Psychotic; Disorder, CannabiscanhopeNCT06314204
Impact of Cannabis Consumption on the Course, Modalities of Hospitalization and the Short-term Prognosis of Inpatients Suffering From Psychotic Symptoms
An observational study of Psychotic; Disorder, Cannabis, run by Centre hospitalier de Ville-Evrard, France at 1 site in France.
Trial summary
Few studies have evaluated, in patients with symptomatology the impact of cannabis use on the duration of hospitalization and on short- and medium-term developments. The objective of this study will be to assess the impact of cannabis on the duration, the hospitalization and the short- and medium-term evolution of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychotic; Disorder, Cannabis
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 20 Sep 2016to 6 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population of this study will consist of patients over the age of 18 with trans-nosographic psychotic symptomatology (schizophrenia, schizoaffective disorder, mood disorder with psychotic characteristic, psychotic disorder induced by substances, brief psychotic disorder, schizophrenic disorder, delirious disorders), hospitalized in psychiatry, free care or under duress in the Hospitalization Units to Full-time (UHTP) EPS Ville-Evrard. This protocol also concerns protected adults. Forecasted number of patients: 200 patients.
Who may be able to join
- Hospitalized in psychiatry regardless of the mode of hospitalization
- With or without protective measures (guardianship or curatorship)
- Presenting psychotic symptoms (schizophrenia, schizo affective disorder, thymic disorder with psychotic characteristic, psychotic disorder substance-induced, brief psychotic disorder, schizophrenic disorders, delirious disorders)
- Members of the social security system
- Enlightened information
Who cannot join
- Degenerative neurological pathologies or mental retardation
- Psychotic disorders secondary to generalized medical conditions(epilepsy, delirium tremens, tumors, etc.)
- Other psychiatric pathologies
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
unité de recherche clinique de l'E.P.S de Ville Evrard
Neuilly-sur-Marne, 93332
Rusheenthira THAVASEELAN, Msc, 0143093232, r.thavaseelan@epsve.fr
About this study
Official title: Impact of Cannabis Consumption on the Course, Modalities of Hospitalization and the Short-term Prognosis of Inpatients Suffering From Psychotic Symptoms : Multicenter Comparative Observational Study
Few studies have evaluated, in patients with symptomatology the impact of cannabis use on the duration of hospitalization and on short- and medium-term developments. The objective of this study will be to assess the impact of cannabis on the duration, the hospitalization and the short- and medium-term evolution of patients with psychotic symptoms and cannabis use. We hypothesize that these patients (in comparison with patients with psychotic symptomatology and not using cannabis) would be hospitalized more long, exposed to a higher risk of resistance to the usual therapeutics, would have a lack of therapeutic alliance and insight, relapses and hospitalizations more frequent, more marked negative symptoms and lower quality remission. They would also be more prone to impulsive and aggressive behaviour.
Read the detailed description
Several studies have reported that cannabis use worsen the prognosis of psychiatric pathologies in general and psychotic in particular.
Few or no studies have evaluated the impact of cannabis consumption on patients with psychotic symptoms during their hospitalization (duration, type of hospitalization, quality of relationship with staff hospital), and on the short-term prognosis.
The objective of this study will be to assess the impact of cannabis on the duration of the hospitalization and the short- and medium-term evolution of patients with a psychotic symptomatology and cannabis use. Making the hypothesis that these patients (compared to patients with symptomatology psychotic and not using cannabis) would be hospitalized longer, exposed at a higher risk of resistance to the usual therapies, to have a lack of alliance therapeutic and insight, relapses and more frequent hospitalizations and symptoms.
They would also be more likely to have lower quality. They would also be more likely to be impulsive, and have aggressive behaviours.
- Conditions
- Psychotic; Disorder, Cannabis
- Keywords
- cannabis-Timing-hospitalization-psychotic sympyomatology
- Medical subject headings
- Mental Disorders, Marijuana Abuse
What is being measured
The primary outcome is the main question the study is designed to answer.
PANSS: Positive and Negative Syndrom Scale
This scale permit to assess the severity of schizophrenia.Positive Scale, Negative Scale, and General Psychopathology Scale. Each subscale is rated with 1 to 7 points ranging from absent to extreme. The range for the Positive and Negative Scales is 7-49, and the range for the General Psychopathology Scale is 16-112. The total PANSS score is simply the sum of the sub scales.
Measured: AT the beginning of the study, before any procedure, (T1)
PANSS: Positive and Negative Syndrom Scale
This scale permit to assess the severity of schizophrenia.Positive Scale, Negative Scale, and General Psychopathology Scale. Each subscale is rated with 1 to 7 points ranging from absent to extreme. The range for the Positive and Negative Scales is 7-49, and the range for the General Psychopathology Scale is 16-112. The total PANSS score is simply the sum of the sub scales.
Measured: Approximatively 2 or 3 weeks after T1,On the day of the discharge (T2)
PANSS: Positive and Negative Syndrom Scale
This scale permit to assess the severity of schizophrenia.Positive Scale, Negative Scale, and General Psychopathology Scale. Each subscale is rated with 1 to 7 points ranging from absent to extreme. The range for the Positive and Negative Scales is 7-49, and the range for the General Psychopathology Scale is 16-112. The total PANSS score is simply the sum of the sub scales.
Measured: 1 month after the discharge (T3)
PANSS: Positive and Negative Syndrom Scale
This scale permit to assess the severity of schizophrenia.Positive Scale, Negative Scale, and General Psychopathology Scale. Each subscale is rated with 1 to 7 points ranging from absent to extreme. The range for the Positive and Negative Scales is 7-49, and the range for the General Psychopathology Scale is 16-112. The total PANSS score is simply the sum of the sub scales.
Measured: 3 month after the discharge (T4)
MCQ-SF :Marijuana Craving Questionnaire- Short Form
The scale permit to determine the marijuana craving. The subscales exhibited low to moderate, positive intercorrelations and were significantly correlated with marijuana use history and a wide range of single-item measures of craving. Conclusions. Findings suggested that four specific constructs characterize craving for marijuana: (1) compulsivity, an inability to control marijuana use; (2) emotionality, use of marijuana in anticipation of relief from withdrawal or negative mood; (3) expectancy, anticipation of positive outcomes from smoking marijuana; and (4) purposefulness, intention and planning to use marijuana for positive outcomes.
Measured: AT the beginning of the study, before any procedure (T1)
MCQ-SF :Marijuana Craving Questionnaire- Short Form)
The scale permit to determine the marijuana craving. The subscales exhibited low to moderate, positive intercorrelations and were significantly correlated with marijuana use history and a wide range of single-item measures of craving. Conclusions. Findings suggested that four specific constructs characterize craving for marijuana: (1) compulsivity, an inability to control marijuana use; (2) emotionality, use of marijuana in anticipation of relief from withdrawal or negative mood; (3) expectancy, anticipation of positive outcomes from smoking marijuana; and (4) purposefulness, intention and planning to use marijuana for positive outcomes.
Measured: Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)
MCQ-SF :Marijuana Craving Questionnaire- Short Form)
The scale permit to determine the marijuana craving. The subscales exhibited low to moderate, positive intercorrelations and were significantly correlated with marijuana use history and a wide range of single-item measures of craving. Conclusions. Findings suggested that four specific constructs characterize craving for marijuana: (1) compulsivity, an inability to control marijuana use; (2) emotionality, use of marijuana in anticipation of relief from withdrawal or negative mood; (3) expectancy, anticipation of positive outcomes from smoking marijuana; and (4) purposefulness, intention and planning to use marijuana for positive outcomes.
Measured: one month after the discharge
MCQ-SF :Marijuana Craving Questionnaire- Short Form)
The scale permit to determine the marijuana craving. The subscales exhibited low to moderate, positive intercorrelations and were significantly correlated with marijuana use history and a wide range of single-item measures of craving. Conclusions. Findings suggested that four specific constructs characterize craving for marijuana: (1) compulsivity, an inability to control marijuana use; (2) emotionality, use of marijuana in anticipation of relief from withdrawal or negative mood; (3) expectancy, anticipation of positive outcomes from smoking marijuana; and (4) purposefulness, intention and planning to use marijuana for positive outcomes.
Measured: three month after the discharge
CGI: Clinical Global Impression
It is used with all patients, allowing the evaluation of the improvement of assessing the severity and change of the overall clinical condition.
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
- Normal, not at all ill
- Borderline mentally ill
- Mildly ill
- Moderately ill
- Markedly ill
- Severely ill
- Among the most extremely ill patients
Improvement scale The clinical global impression - improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
- Very much improved
- Much improved
- Minimally improved
- No change
- Minimally worse
- Much worse
- Very much worse
Measured: AT the beginning of the study, before any procedure (T1)
CGI: Clinical Global Impression
It is used with all patients, allowing the evaluation of the improvement of assessing the severity and change of the overall clinical condition.
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
- Normal, not at all ill
- Borderline mentally ill
- Mildly ill
- Moderately ill
- Markedly ill
- Severely ill
- Among the most extremely ill patients
Improvement scale The clinical global impression - improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
- Very much improved
- Much improved
- Minimally improved
- No change
- Minimally worse
- Much worse
- Very much worse
Measured: Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)
CGI: Clinical Global Impression
It is used with all patients, allowing the evaluation of the improvement of assessing the severity and change of the overall clinical condition.
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
- Normal, not at all ill
- Borderline mentally ill
- Mildly ill
- Moderately ill
- Markedly ill
- Severely ill
- Among the most extremely ill patients
Improvement scale The clinical global impression - improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
- Very much improved
- Much improved
- Minimally improved
- No change
- Minimally worse
- Much worse
- Very much worse
Measured: one month after the discharge
CGI: Clinical Global Impression
It is used with all patients, allowing the evaluation of the improvement of assessing the severity and change of the overall clinical condition.
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
- Normal, not at all ill
- Borderline mentally ill
- Mildly ill
- Moderately ill
- Markedly ill
- Severely ill
- Among the most extremely ill patients
Improvement scale The clinical global impression - improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
- Very much improved
- Much improved
- Minimally improved
- No change
- Minimally worse
- Much worse
- Very much worse
Measured: three month after the discharge
MADRS: Montgomery Åsberg Depression Rating Scale
It is validated in France by Pellet and its collaborators in 1987. It allows to evaluate the modifications of mood.
It has 10 psychic and somatic items (apparent sadness, sadness expressed, inner tension, insomnia, loss of appetite, difficulty concentrating, weariness, loss of feelings, pessimism and thoughts of suicide) sides from 0 to 6 according to the 6 degrees of severity and whose scores add up.
Measured: AT the beginning of the study, before any procedure (T1)
MADRS: Montgomery Åsberg Depression Rating Scale
It is validated in France by Pellet and its collaborators in 1987. It allows to evaluate the modifications of mood.
It has 10 psychic and somatic items (apparent sadness, sadness expressed, inner tension, insomnia, loss of appetite, difficulty concentrating, weariness, loss of feelings, pessimism and thoughts of suicide) sides from 0 to 6 according to the 6 degrees of severity and whose scores add up.
Measured: Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)
MADRS: Montgomery Åsberg Depression Rating Scale
It is validated in France by Pellet and its collaborators in 1987. It allows to evaluate the modifications of mood.
It has 10 psychic and somatic items (apparent sadness, sadness expressed, inner tension, insomnia, loss of appetite, difficulty concentrating, weariness, loss of feelings, pessimism and thoughts of suicide) sides from 0 to 6 according to the 6 degrees of severity and whose scores add up.
Measured: one month after the discharge
MADRS: Montgomery Åsberg Depression Rating Scale
It is validated in France by Pellet and its collaborators in 1987. It allows to evaluate the modifications of mood.
It has 10 psychic and somatic items (apparent sadness, sadness expressed, inner tension, insomnia, loss of appetite, difficulty concentrating, weariness, loss of feelings, pessimism and thoughts of suicide) sides from 0 to 6 according to the 6 degrees of severity and whose scores add up.
Measured: Three month after the discharge
PDS: Psychotic Depression Scale
It is composed of 32 items. Among the PDS items, those related to the "mood" factors depressive" (8 items) and "vegetative signs" (3 items) allow an evaluation of the depression regardless of negative symptoms or extrapyramidal symptoms.
All items are scoring from 0 to 6:
0: nothing 2 :light 4: important 6: extreme
Measured: AT the beginning of the study, before any procedure (T1)
PDS: Psychotic Depression Scale
It is composed of 32 items. Among the PDS items, those related to the "mood" factors depressive" (8 items) and "vegetative signs" (3 items) allow an evaluation of the depression regardless of negative symptoms or extrapyramidal symptoms.
All items are scoring from 0 to 6:
0: nothing 2 :light 4: important 6: extreme
Measured: Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)
PDS: Psychotic Depression Scale
It is composed of 32 items. Among the PDS items, those related to the "mood" factors depressive" (8 items) and "vegetative signs" (3 items) allow an evaluation of the depression regardless of negative symptoms or extrapyramidal symptoms. The overall PDS score is correlated to the overall MADRS scores.
All items are scoring from 0 to 6:
0: nothing 2 :light 4: important 6: extreme
Measured: one month after the discharge
PDS: Psychotic Depression Scale
It is composed of 32 items. Among the PDS items, those related to the "mood" factors depressive" (8 items) and "vegetative signs" (3 items) allow an evaluation of the depression regardless of negative symptoms or extrapyramidal symptoms. The overall PDS score is correlated to the overall MADRS scores.
All items are scoring from 0 to 6:
0: nothing 2 :light 4: important 6: extreme
Measured: Three month after the discharge
YMRS: Young Mania Rating Scale
The YMRS is a scale of 11 questions to assess the severity of symptoms maniacs. It is considered the gold standard of scales evaluating mania.
This instrument is widely used both in the clinic and in research. It is appropriate both to assess the initial severity of manic symptoms, and the response to treatment in patients with bipolar disorder type I and II. Each item of YMRS given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale.
There are well described anchor points for each grade of severity.
Measured: AT the beginning of the study, before any procedure (T1)
YMRS: Young Mania Rating Scale
The YMRS is a scale of 11 questions to assess the severity of symptoms maniacs. It is considered the gold standard of scales evaluating mania.
This instrument is widely used both in the clinic and in research. It is appropriate both to assess the initial severity of manic symptoms, and the response to treatment in patients with bipolar disorder type I and II. Each item of YMRS given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale.
There are well described anchor points for each grade of severity.
Measured: Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)
YMRS: Young Mania Rating Scale
The YMRS is a scale of 11 questions to assess the severity of symptoms maniacs. It is considered the gold standard of scales evaluating mania.
This instrument is widely used both in the clinic and in research. It is appropriate both to assess the initial severity of manic symptoms, and the response to treatment in patients with bipolar disorder type I and II. Each item of YMRS given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale.
There are well described anchor points for each grade of severity.
Measured: one month after the discharge
YMRS: Young Mania Rating Scale
The YMRS is a scale of 11 questions to assess the severity of symptoms maniacs. It is considered the gold standard of scales evaluating mania.
This instrument is widely used both in the clinic and in research. It is appropriate both to assess the initial severity of manic symptoms, and the response to treatment in patients with bipolar disorder type I and II. Each item of YMRS given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale.
There are well described anchor points for each grade of severity.
Measured: Three month after the discharge
CDS: Self-Consciousness Revised Scale
This scale represents a cross-cultural validation in of the Self-Consciousness Revised Scale by Scheier et al. This scale measures three aspects of the self-awareness, that is, private, public self-awareness and social anxiety. It includes 22 statements. The scale is rating 0-3 point:
0: not at all like me
- a little bit like me
- quite similar to me
- Very much like me . The time to complete will be 10 minutes.
Measured: Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)
CTQ: Childhood Trauma Questionnaire
The Child Trauma Questionnaire is a questionnaire developed by Bernstein et al. (1994) which includes 70 items with a scale of type Likert in five answer choices (from 1 = "never true" to 5 = "very often true").
It was developed from a detailed review of the literature on abuse and also from experience a structured interview, the Childhood Trauma Interview, developed by the same authors. The ten minutes will be required.
Measured: Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)
BFI: Big Five Inventory
The Personality Dimension Scale, BIG FIVE, FFS: John et al. developed the Big Five Inventory (BFI). This consists of 44 items in its American version, consisting of short phrases based on the adjectives of traits known to be the prototype markers of the "Big Five" John et al. no longer denotes the factors but assigns them a letter accompanied by a set of explanatory and synthetic terms of the definition: E (Extraversion, Energy, Enthusiasm); A (Agreeability, Altruism, Affection); C (Consciousness, Control, Constraint); N (Negative Emotions, Neuroticism, Nervousness); O (Openness, Originality, Openness).
The Time of passing is 10 minutes.
- disagree strongly
- disagree a little
- Neither agree or nor disagree
- agree a little
- agree strongly
Measured: Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start20 Sep 2016
- Primary completion6 Sep 2025 (estimated)
- Study completion6 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic; Disorder, CannabisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de Ville-Evrard, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noomane Bouaziz, MD, Centre hospitalier de Ville-Evrard, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314204
- Sponsor's protocol ID
- 2015-A01222-47
- Acronym
- canhope
- Status last verified
- Mar 2024
- First submitted
- 29 Feb 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cannabis Consumption on the Course, Modalities of Hospitalization and the Short-term Prognosis of Inpatients Suffering From Psychotic Symptoms : Multicenter Comparative Observational Study
- ClinicalTrials.gov ID
- NCT06314204
- Acronym / sponsor ID
- canhope / 2015-A01222-47
- Conditions
- Psychotic; Disorder, Cannabis
- Keywords
- cannabis-Timing-hospitalization-psychotic sympyomatology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre hospitalier de Ville-Evrard, FranceUniversity, hospital or other
- Study start
- 20 Sep 2016 (actual)
- Primary completion
- 6 Sep 2025 (estimated)
- Study completion
- 6 Sep 2026 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Few studies have evaluated, in patients with symptomatology the impact of cannabis use on the duration of hospitalization and on short- and medium-term developments. The objective of this study will be to assess the impact of cannabis on the duration, the hospitalization and the short- and medium-term evolution of patients with psychotic symptoms and cannabis use. We hypothesize that these patients (in comparison with patients with psychotic symptomatology and not using cannabis) would be hospitalized more long, exposed to a higher risk of resistance to the usual therapeutics, would have a lack of therapeutic alliance and insight, relapses and hospitalizations more frequent, more marked negative symptoms and lower quality remission. They would also be more prone to impulsive and aggressive behaviour.
Detailed description
Several studies have reported that cannabis use worsen the prognosis of psychiatric pathologies in general and psychotic in particular.
Few or no studies have evaluated the impact of cannabis consumption on patients with psychotic symptoms during their hospitalization (duration, type of hospitalization, quality of relationship with staff hospital), and on the short-term prognosis.
The objective of this study will be to assess the impact of cannabis on the duration of the hospitalization and the short- and medium-term evolution of patients with a psychotic symptomatology and cannabis use. Making the hypothesis that these patients (compared to patients with symptomatology psychotic and not using cannabis) would be hospitalized longer, exposed at a higher risk of resistance to the usual therapies, to have a lack of alliance therapeutic and insight, relapses and more frequent hospitalizations and symptoms.
They would also be more likely to have lower quality. They would also be more likely to be impulsive, and have aggressive behaviours.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of this study will consist of patients over the age of 18 with trans-nosographic psychotic symptomatology (schizophrenia, schizoaffective disorder, mood disorder with psychotic characteristic, psychotic disorder induced by substances, brief psychotic disorder, schizophrenic disorder, delirious disorders), hospitalized in psychiatry, free care or under duress in the Hospitalization Units to Full-time (UHTP) EPS Ville-Evrard. This protocol also concerns protected adults. Forecasted number of patients: 200 patients.
Key inclusion criteria (5 listed)
- Hospitalized in psychiatry regardless of the mode of hospitalization
- With or without protective measures (guardianship or curatorship)
- Presenting psychotic symptoms (schizophrenia, schizo affective disorder, thymic disorder with psychotic characteristic, psychotic disorder substance-induced, brief psychotic disorder, schizophrenic disorders, delirious disorders)
- Members of the social security system
- Enlightened information
Key exclusion criteria (3 listed)
- Degenerative neurological pathologies or mental retardation
- Psychotic disorders secondary to generalized medical conditions(epilepsy, delirium tremens, tumors, etc.)
- Other psychiatric pathologies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PANSS: Positive and Negative Syndrom Scale
Time frame: AT the beginning of the study, before any procedure, (T1)
This scale permit to assess the severity of schizophrenia.Positive Scale, Negative Scale, and General Psychopathology Scale. Each subscale is rated with 1 to 7 points ranging from absent to extreme. The range for the Positive and Negative Scales is 7-49, and the range for the General Psychopathology Scale is 16-112. The total PANSS score is simply the sum of the sub scales.
PANSS: Positive and Negative Syndrom Scale
Time frame: Approximatively 2 or 3 weeks after T1,On the day of the discharge (T2)
This scale permit to assess the severity of schizophrenia.Positive Scale, Negative Scale, and General Psychopathology Scale. Each subscale is rated with 1 to 7 points ranging from absent to extreme. The range for the Positive and Negative Scales is 7-49, and the range for the General Psychopathology Scale is 16-112. The total PANSS score is simply the sum of the sub scales.
PANSS: Positive and Negative Syndrom Scale
Time frame: 1 month after the discharge (T3)
This scale permit to assess the severity of schizophrenia.Positive Scale, Negative Scale, and General Psychopathology Scale. Each subscale is rated with 1 to 7 points ranging from absent to extreme. The range for the Positive and Negative Scales is 7-49, and the range for the General Psychopathology Scale is 16-112. The total PANSS score is simply the sum of the sub scales.
PANSS: Positive and Negative Syndrom Scale
Time frame: 3 month after the discharge (T4)
This scale permit to assess the severity of schizophrenia.Positive Scale, Negative Scale, and General Psychopathology Scale. Each subscale is rated with 1 to 7 points ranging from absent to extreme. The range for the Positive and Negative Scales is 7-49, and the range for the General Psychopathology Scale is 16-112. The total PANSS score is simply the sum of the sub scales.
MCQ-SF :Marijuana Craving Questionnaire- Short Form
Time frame: AT the beginning of the study, before any procedure (T1)
The scale permit to determine the marijuana craving. The subscales exhibited low to moderate, positive intercorrelations and were significantly correlated with marijuana use history and a wide range of single-item measures of craving. Conclusions. Findings suggested that four specific constructs characterize craving for marijuana: (1) compulsivity, an inability to control marijuana use; (2) emotionality, use of marijuana in anticipation of relief from withdrawal or negative mood; (3) expectancy, anticipation of positive outcomes from smoking marijuana; and (4) purposefulness, intention and planning to use marijuana for positive outcomes.
MCQ-SF :Marijuana Craving Questionnaire- Short Form)
Time frame: Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)
The scale permit to determine the marijuana craving. The subscales exhibited low to moderate, positive intercorrelations and were significantly correlated with marijuana use history and a wide range of single-item measures of craving. Conclusions. Findings suggested that four specific constructs characterize craving for marijuana: (1) compulsivity, an inability to control marijuana use; (2) emotionality, use of marijuana in anticipation of relief from withdrawal or negative mood; (3) expectancy, anticipation of positive outcomes from smoking marijuana; and (4) purposefulness, intention and planning to use marijuana for positive outcomes.
MCQ-SF :Marijuana Craving Questionnaire- Short Form)
Time frame: one month after the discharge
The scale permit to determine the marijuana craving. The subscales exhibited low to moderate, positive intercorrelations and were significantly correlated with marijuana use history and a wide range of single-item measures of craving. Conclusions. Findings suggested that four specific constructs characterize craving for marijuana: (1) compulsivity, an inability to control marijuana use; (2) emotionality, use of marijuana in anticipation of relief from withdrawal or negative mood; (3) expectancy, anticipation of positive outcomes from smoking marijuana; and (4) purposefulness, intention and planning to use marijuana for positive outcomes.
MCQ-SF :Marijuana Craving Questionnaire- Short Form)
Time frame: three month after the discharge
The scale permit to determine the marijuana craving. The subscales exhibited low to moderate, positive intercorrelations and were significantly correlated with marijuana use history and a wide range of single-item measures of craving. Conclusions. Findings suggested that four specific constructs characterize craving for marijuana: (1) compulsivity, an inability to control marijuana use; (2) emotionality, use of marijuana in anticipation of relief from withdrawal or negative mood; (3) expectancy, anticipation of positive outcomes from smoking marijuana; and (4) purposefulness, intention and planning to use marijuana for positive outcomes.
CGI: Clinical Global Impression
Time frame: AT the beginning of the study, before any procedure (T1)
It is used with all patients, allowing the evaluation of the improvement of assessing the severity and change of the overall clinical condition. The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. 1. Normal, not at all ill 2. Borderline mentally ill 3. Mildly ill 4. Moderately ill 5. Markedly ill 6. Severely ill 7. Among the most extremely ill patients Improvement scale The clinical global impression - improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse
CGI: Clinical Global Impression
Time frame: Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)
It is used with all patients, allowing the evaluation of the improvement of assessing the severity and change of the overall clinical condition. The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. 1. Normal, not at all ill 2. Borderline mentally ill 3. Mildly ill 4. Moderately ill 5. Markedly ill 6. Severely ill 7. Among the most extremely ill patients Improvement scale The clinical global impression - improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse
CGI: Clinical Global Impression
Time frame: one month after the discharge
It is used with all patients, allowing the evaluation of the improvement of assessing the severity and change of the overall clinical condition. The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. 1. Normal, not at all ill 2. Borderline mentally ill 3. Mildly ill 4. Moderately ill 5. Markedly ill 6. Severely ill 7. Among the most extremely ill patients Improvement scale The clinical global impression - improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse
CGI: Clinical Global Impression
Time frame: three month after the discharge
It is used with all patients, allowing the evaluation of the improvement of assessing the severity and change of the overall clinical condition. The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. 1. Normal, not at all ill 2. Borderline mentally ill 3. Mildly ill 4. Moderately ill 5. Markedly ill 6. Severely ill 7. Among the most extremely ill patients Improvement scale The clinical global impression - improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse
MADRS: Montgomery Åsberg Depression Rating Scale
Time frame: AT the beginning of the study, before any procedure (T1)
It is validated in France by Pellet and its collaborators in 1987. It allows to evaluate the modifications of mood. It has 10 psychic and somatic items (apparent sadness, sadness expressed, inner tension, insomnia, loss of appetite, difficulty concentrating, weariness, loss of feelings, pessimism and thoughts of suicide) sides from 0 to 6 according to the 6 degrees of severity and whose scores add up.
MADRS: Montgomery Åsberg Depression Rating Scale
Time frame: Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)
It is validated in France by Pellet and its collaborators in 1987. It allows to evaluate the modifications of mood. It has 10 psychic and somatic items (apparent sadness, sadness expressed, inner tension, insomnia, loss of appetite, difficulty concentrating, weariness, loss of feelings, pessimism and thoughts of suicide) sides from 0 to 6 according to the 6 degrees of severity and whose scores add up.
MADRS: Montgomery Åsberg Depression Rating Scale
Time frame: one month after the discharge
It is validated in France by Pellet and its collaborators in 1987. It allows to evaluate the modifications of mood. It has 10 psychic and somatic items (apparent sadness, sadness expressed, inner tension, insomnia, loss of appetite, difficulty concentrating, weariness, loss of feelings, pessimism and thoughts of suicide) sides from 0 to 6 according to the 6 degrees of severity and whose scores add up.
MADRS: Montgomery Åsberg Depression Rating Scale
Time frame: Three month after the discharge
It is validated in France by Pellet and its collaborators in 1987. It allows to evaluate the modifications of mood. It has 10 psychic and somatic items (apparent sadness, sadness expressed, inner tension, insomnia, loss of appetite, difficulty concentrating, weariness, loss of feelings, pessimism and thoughts of suicide) sides from 0 to 6 according to the 6 degrees of severity and whose scores add up.
PDS: Psychotic Depression Scale
Time frame: AT the beginning of the study, before any procedure (T1)
It is composed of 32 items. Among the PDS items, those related to the "mood" factors depressive" (8 items) and "vegetative signs" (3 items) allow an evaluation of the depression regardless of negative symptoms or extrapyramidal symptoms. All items are scoring from 0 to 6: 0: nothing 2 :light 4: important 6: extreme
PDS: Psychotic Depression Scale
Time frame: Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)
It is composed of 32 items. Among the PDS items, those related to the "mood" factors depressive" (8 items) and "vegetative signs" (3 items) allow an evaluation of the depression regardless of negative symptoms or extrapyramidal symptoms. All items are scoring from 0 to 6: 0: nothing 2 :light 4: important 6: extreme
PDS: Psychotic Depression Scale
Time frame: one month after the discharge
It is composed of 32 items. Among the PDS items, those related to the "mood" factors depressive" (8 items) and "vegetative signs" (3 items) allow an evaluation of the depression regardless of negative symptoms or extrapyramidal symptoms. The overall PDS score is correlated to the overall MADRS scores. All items are scoring from 0 to 6: 0: nothing 2 :light 4: important 6: extreme
PDS: Psychotic Depression Scale
Time frame: Three month after the discharge
It is composed of 32 items. Among the PDS items, those related to the "mood" factors depressive" (8 items) and "vegetative signs" (3 items) allow an evaluation of the depression regardless of negative symptoms or extrapyramidal symptoms. The overall PDS score is correlated to the overall MADRS scores. All items are scoring from 0 to 6: 0: nothing 2 :light 4: important 6: extreme
YMRS: Young Mania Rating Scale
Time frame: AT the beginning of the study, before any procedure (T1)
The YMRS is a scale of 11 questions to assess the severity of symptoms maniacs. It is considered the gold standard of scales evaluating mania. This instrument is widely used both in the clinic and in research. It is appropriate both to assess the initial severity of manic symptoms, and the response to treatment in patients with bipolar disorder type I and II. Each item of YMRS given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. There are well described anchor points for each grade of severity.
YMRS: Young Mania Rating Scale
Time frame: Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)
The YMRS is a scale of 11 questions to assess the severity of symptoms maniacs. It is considered the gold standard of scales evaluating mania. This instrument is widely used both in the clinic and in research. It is appropriate both to assess the initial severity of manic symptoms, and the response to treatment in patients with bipolar disorder type I and II. Each item of YMRS given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. There are well described anchor points for each grade of severity.
YMRS: Young Mania Rating Scale
Time frame: one month after the discharge
The YMRS is a scale of 11 questions to assess the severity of symptoms maniacs. It is considered the gold standard of scales evaluating mania. This instrument is widely used both in the clinic and in research. It is appropriate both to assess the initial severity of manic symptoms, and the response to treatment in patients with bipolar disorder type I and II. Each item of YMRS given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. There are well described anchor points for each grade of severity.
YMRS: Young Mania Rating Scale
Time frame: Three month after the discharge
The YMRS is a scale of 11 questions to assess the severity of symptoms maniacs. It is considered the gold standard of scales evaluating mania. This instrument is widely used both in the clinic and in research. It is appropriate both to assess the initial severity of manic symptoms, and the response to treatment in patients with bipolar disorder type I and II. Each item of YMRS given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. There are well described anchor points for each grade of severity.
CDS: Self-Consciousness Revised Scale
Time frame: Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)
This scale represents a cross-cultural validation in of the Self-Consciousness Revised Scale by Scheier et al. This scale measures three aspects of the self-awareness, that is, private, public self-awareness and social anxiety. It includes 22 statements. The scale is rating 0-3 point: 0: not at all like me 1. a little bit like me 2. quite similar to me 3. Very much like me . The time to complete will be 10 minutes.
CTQ: Childhood Trauma Questionnaire
Time frame: Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)
The Child Trauma Questionnaire is a questionnaire developed by Bernstein et al. (1994) which includes 70 items with a scale of type Likert in five answer choices (from 1 = "never true" to 5 = "very often true"). It was developed from a detailed review of the literature on abuse and also from experience a structured interview, the Childhood Trauma Interview, developed by the same authors. The ten minutes will be required.
BFI: Big Five Inventory
Time frame: Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)
The Personality Dimension Scale, BIG FIVE, FFS: John et al. developed the Big Five Inventory (BFI). This consists of 44 items in its American version, consisting of short phrases based on the adjectives of traits known to be the prototype markers of the "Big Five" John et al. no longer denotes the factors but assigns them a letter accompanied by a set of explanatory and synthetic terms of the definition: E (Extraversion, Energy, Enthusiasm); A (Agreeability, Altruism, Affection); C (Consciousness, Control, Constraint); N (Negative Emotions, Neuroticism, Nervousness); O (Openness, Originality, Openness). The Time of passing is 10 minutes. 1. disagree strongly 2. disagree a little 3. Neither agree or nor disagree 4. agree a little 5. agree strongly
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychotic; Disorder, Cannabis, run by Centre hospitalier de Ville-Evrard, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact RUSHEENTHIRA THAVASEELAN, MSc (0143083232, r.thavaseelan@epsve.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PANSS: Positive and Negative Syndrom Scale (time frame: AT the beginning of the study, before any procedure, (T1)). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.