Dissociative DisordersNCT01512641
Prevalence of Dissociative Disorders in Children
A study testing Primary stage and Secondary stage in people with Dissociative Disorders and Schizophrenia, run by Centre Hospitalier Universitaire de Nice at 4 sites in France.
Trial summary
Schizophrenia beginning before 18 years is a clinical entity not well known because of its low incidence and difficulties in the clinical diagnosis. However, in the investigators clinical practice, due to the specialization of the investigators service, the investigators are led to hospital to receive important feel… Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Dissociative Disorders, Schizophrenia
- What is being tested?
- Primary stage and Secondary stage
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 4 sitesFrance
- Study dates
- Dec 2011to May 2013
- Phase
- Interventional
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 7 to 18 years
- Supported in the partner institutions of the study
- IQ>35 on the certificate of orientation of the Maison Départementale des Personnes Handicapées (MDPH)
- Obtaining the agreement of parents and children
Who cannot join
- QI<35 on the certificate file Guidance MDPH
- Children not speaking french
Trial locations and contacts
4 sites in 1 country.
France4 sites
Psychiatrie infanto-juvénile - Centre Hospitalier d'Antibes
Antibes, 06600
Psychiatrie infanto-juvénile-Pôle femme-mère -enfant
Fréjus, 83608
Service de psychiatrie de l'enfant et de l'adolescent
Marseille, 13009
Service de psychiatrie de l'enfant et de l'adolescent
Nice, 06000
About this study
Official title: Prevalence of Dissociative Disorders in Children in a Population Supported in the Medico-social and Health Structures in Provence Alpes Cote d'Azur
Schizophrenia beginning before 18 years is a clinical entity not well known because of its low incidence and difficulties in the clinical diagnosis.
However, in the investigators clinical practice, due to the specialization of the investigators service, the investigators are led to hospital to receive important feel active of patients meeting the Diagnostic and Statistical Manual of Mental Disorders IV text revision (DSM IV-TR) precose schizophrenia.
Read more
The work of us team on the theme of the relationship between Pervasive Developmental Disorders and precose Schizophrenia led us to hypothesize that a number of children in care in the medical and educational institutes, hospitals and day shelters therapeutic part-time symptoms of schizophrenia or a line real early diagnosis of schizophrenia undervalued or not diagnosed.
The main goal is to estimate the prevalence of dissociative disorders in a population of children in care institutions and medical education in child psychiatry in hospitals and others structures.
- Conditions
- Dissociative Disorders, Schizophrenia
- Being tested
- Primary stage, Secondary stage
- Keywords
- children dissociative disorders schizophrenia
- Medical subject headings
- Dissociative Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary stageOther
Kiddie-Schedule for Affective Disorders and Schizophrenia
Secondary stageOther
children who are positive to the kiddie-SADS (primary stage), will take the tests: PANSS, Scale for the Assessment of Negative Symptoms (SANS), ADI-R, scale TLC and WISC IV
| Study group | Role | What they receive |
|---|---|---|
| Children with Dissociative Disorders | Experimental | Children will take first the primary stage. If one child is positive, he will pass the secondary stage. Receives: Other: Primary stage; Other: Secondary stage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of children diagnosed with dissociative disorders
Rate of children diagnosed with dissociative disorders: children positive for the test Kiddie-Schedule for Affective Disorders and Schizophrenia (Kiddie-SADS).
Measured: between 2 and 4 hours depending children
Secondary outcomes (5)
Percentage of children positive for test: Autism Diagnostic Interview-Revise (ADI-R).
Measured: 1 day on average
Scores of three dimensions of schizophrenia in the Positive And Negative Syndrome Scale (PANSS)
3 dimensions: positive symptoms, negative symptoms and general psychopathology, based on these scores the diagnostic subtype of schizophrenia is established.
Measured: 4 hours
Score at the Test Lillois de Communication (TLC)
Measured: 30 minutes
Score on the Wechsler Intelligence Scale for Children-Fourth Edition (WISC IV)subtests and overall intelligence quotient (IQ).
Measured: 4 hours
Response time to test verbal fluency, scores on the Trail Making Test A (TMT) and TMT B.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dissociative DisordersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence ASKENAZY, PU-PH, Study director, University hospital of NiceEmmanuelle DOR, PH, Principal investigator, University hospital of NiceFrançois POINSO, PU-PH, Principal investigator, AP-HMMichèle BATTISTA, PH, Principal investigator, Frejus's hospitalMichel BOUBLIL, PH, Principal investigator, Antibes's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512641
- Sponsor's protocol ID
- 11-API-01
- Status last verified
- Jan 2014
- First submitted
- 13 Dec 2011
- Last updated
- 3 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Dor-Nedonsel E, Menard ML, Fernandez A, Sakarovitch C, Fontas E, Salle-Collemiche X, Poinso F, Tosello AL, Maria F, Manera V, Askenazy F, Thummler S. Early-Onset Schizophrenia in a paediatric population of French psychiatric and medico-social care centres: A cross sectional study. PLoS One. 2020 Jul 27;15(7):e0236241. doi: 10.1371/journal.pone.0236241. eCollection 2020.
PubMed 32716957
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Dissociative Disorders in Children in a Population Supported in the Medico-social and Health Structures in Provence Alpes Cote d'Azur
- ClinicalTrials.gov ID
- NCT01512641
- Acronym / sponsor ID
- 11-API-01
- Conditions
- Dissociative Disorders, Schizophrenia
- Keywords
- children dissociative disorders schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 19 Jan 2012 (estimated)
- 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.
Schizophrenia beginning before 18 years is a clinical entity not well known because of its low incidence and difficulties in the clinical diagnosis.
However, in the investigators clinical practice, due to the specialization of the investigators service, the investigators are led to hospital to receive important feel active of patients meeting the Diagnostic and Statistical Manual of Mental Disorders IV text revision (DSM IV-TR) precose schizophrenia.
The work of us team on the theme of the relationship between Pervasive Developmental Disorders and precose Schizophrenia led us to hypothesize that a number of children in care in the medical and educational institutes, hospitals and day shelters therapeutic part-time symptoms of schizophrenia or a line real early diagnosis of schizophrenia undervalued or not diagnosed.
The main goal is to estimate the prevalence of dissociative disorders in a population of children in care institutions and medical education in child psychiatry in hospitals and others structures.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with Dissociative Disorders | Experimental | Other: Primary stage, Other: Secondary stageChildren will take first the primary stage. If one child is positive, he will pass the secondary stage. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 7 to 18 years
- Supported in the partner institutions of the study
- IQ>35 on the certificate of orientation of the Maison Départementale des Personnes Handicapées (MDPH)
- Obtaining the agreement of parents and children
Key exclusion criteria (2 listed)
- QI<35 on the certificate file Guidance MDPH
- Children not speaking french
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary stageKiddie-Schedule for Affective Disorders and Schizophrenia | Other | Children with Dissociative Disorders |
| Secondary stagechildren who are positive to the kiddie-SADS (primary stage), will take the tests: PANSS, Scale for the Assessment of Negative Symptoms (SANS), ADI-R, scale TLC and WISC IV | Other | Children with Dissociative Disorders |
Primary outcome
Rate of children diagnosed with dissociative disorders
Time frame: between 2 and 4 hours depending children
Rate of children diagnosed with dissociative disorders: children positive for the test Kiddie-Schedule for Affective Disorders and Schizophrenia (Kiddie-SADS).
5 secondary outcomes
Percentage of children positive for test: Autism Diagnostic Interview-Revise (ADI-R).
Time frame: 1 day on average
Scores of three dimensions of schizophrenia in the Positive And Negative Syndrome Scale (PANSS)
Time frame: 4 hours
Score at the Test Lillois de Communication (TLC)
Time frame: 30 minutes
Score on the Wechsler Intelligence Scale for Children-Fourth Edition (WISC IV)subtests and overall intelligence quotient (IQ).
Time frame: 4 hours
Response time to test verbal fluency, scores on the Trail Making Test A (TMT) and TMT B.
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2014.
- Derived from this study: PubMed 32716957Dor-Nedonsel E, Menard ML, Fernandez A, Sakarovitch C, Fontas E, Salle-Collemiche X, Poinso F, Tosello AL, Maria F, Manera V, Askenazy F, Thummler S. Early-Onset Schizophrenia in a paediatric population of French psychiatric and medico-social care centres: A cross sectional study. PLoS One. 2020 Jul 27;15(7):e0236241. doi: 10.1371/journal.pone.0236241. eCollection 2020.
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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.
Florence ASKENAZY, PU-PH study director
University hospital of Nice
Emmanuelle DOR, PH principal investigator
University hospital of Nice
François POINSO, PU-PH principal investigator
AP-HM
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary stage and Secondary stage in people with Dissociative Disorders and Schizophrenia, run by Centre Hospitalier Universitaire de Nice at 4 sites 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 3 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of children diagnosed with dissociative disorders (time frame: between 2 and 4 hours depending children). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01512641, which also lists 1 linked publication.
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 3 Feb 2014.