Depressive DisorderEMOKETNCT06630065
Study of the Neural Circuits Underlying the Negative Emotional Bias of Depressive Disorders and Their Response to Ketamine
A study testing fMRI with emotional task and pupillometry, Behavioral task with emotional facial expressions and Biological investigation in people with Depressive Disorder, run by Centre Hospitalier St Anne at 1 site in France.
Trial summary
Major depressive disorder is the leading cause of disability worldwide, affecting up to 300 million people each year, and one in five people will experience depression at least once in their lives. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- fMRI with emotional task and pupillometry, Behavioral task with emotional facial expressions and Biological investigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 13 Mar 2023to 13 Apr 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient inclusion criteria :
- Age over 18
- Patient hospitalized or consulting at GHU Paris Psychiatrie et Neurosciences
- Patient with EDC (unipolar or bipolar) diagnosed according to the DSM-5 CRITERIA
- With MADRS score > 20
- For whom a course of esketamine has been decided by the psychiatrist of the patient
Show all 10Show fewer
- Patient having given written informed consent
- Patient covered by a social security plan
- Over 18 years old
- No EDC assessed by MADRS < 8
Who cannot join
- Patient non-inclusion criteria:
- Psychiatric comorbidities: schizophrenic disorder or schizoaffective disorder, history of recreational use of ketamine
- Protected adults, persons under legal protection
- Contraindications to MRI, including refusal to be informed of the discovery of a clinically significant abnormality on MRI
- Pregnant or breast-feeding women
- Usual contraindications to esketamine :
Show all 12Show fewer
- Neurological comorbidity: epilepsy, neurodegenerative disease, cerebrovascular disease with recent history (< 3 months) of stroke or ischemic attack or transient ischemic attack
- Cardiological co-morbidity: vascular aneurysm, ischemic heart disease with acute elements or stent within the previous 12 months, uncontrolled hypertension, heart failure, rhythm or conduction disorders on ECG
- History of cirrhosis (or ALAT, ASAT or bilirubin greater than 2 N)
- Severe chronic respiratory insufficiency
- MADRS <8
- Contraindications to MRI, including refusal to be informed of a clinically significant clinically significant abnormality on MRI
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
- Groupe hospitalo-universitaire Paris Psychiatrie et Neurosciences
Paris, Paris, 75014
Chantal Henry, Pr, 0145658452, ch.henry@ghu-paris.fr
About this study
Official title: Translational Study of the Neural Circuits Underlying the Negative Emotional Bias of Depressive Disorders and Their Response to Ketamine
Major depressive disorder is the leading cause of disability worldwide, affecting up to 300 million people each year, and one in five people will experience depression at least once in their lives. Emotional bias is an essential component of characterized depressive episodes, leading depressed patients to attribute a more negative valence to emotional stimuli.
On the basis of recent and robust neuroscientific data revisiting the role of the cerebral amygdala as an essential essential structure for encoding the negative and positive valences and of emotional stimuli, the team has shown in mice that a depressive phenotype induced by a chronic administration of corticosterone, a well-known model of depression, is associated with a change in hedonic value allocation, i.e. pleasant odors become less pleasant, and aversive odors become even more unpleasant, mimicking what happens in humans (identical data in humans).
Read more
It assumes that:
- There is a negative emotional bias in depressed patients compared with control subjects, evidenced by the assignment of more negative valences when viewing images.
- In depressed subjects, compared with controls subjects, there is greater activation of the basolateral amygdala/ventral hippocampus pathway (the level of imaging resolution of imaging does not allow to study the basolateral amygdala/central amygdala pathway in humans) and less of the basolateral amygdala/nucleus accumbens pathway.
- In depressed subjects, improvement in negative emotional bias correlated with a good response after after 4 weeks of treatment with esketamine (Spravato) measured by a 50% reduction in the Montgomery-Åsberg Depression Rating Scale.
- In depressed patients, early improvement of emotional bias (after a single administration) is predictive of response to treatment at 4 weeks.
- In depressed patients with a good response to a single 4-weeks course of esketamine (Spravato), a normalization of activation of basolateral amygdala/ventral hippocampus and basolateral amygdala/nucleus accumbens pathways is observed.
- Depressed subjects have different immunoinflammatory and RNA editing patterns different from control subjects.
- In depressed patients, clinical improvement correlates with normalization of patients; inflammatory profile and certain mRNA editing
- Some clinical features of major depressive disorder are associated with greater negative emotional bias significant
- Conditions
- Depressive Disorder
- Being tested
- fMRI with emotional task and pupillometry, Behavioral task with emotional facial expressions, Biological investigation
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRI with emotional task and pupillometryBehavioural
Anatomical and functional magnetic resonance imaging (fMRI) imaging sequences with pupillometry (~90 min)
A functional sequence - Task (~20min):
- Emotional task in fMRI: Instructions: simply look images, then evaluate the emotions triggered at the end of each block; rating on a valence and intensity scale and intensity (arousal) scale.
- Experimental conditions: positive, negative and neutral
- Paradigm: block validated image banks: IAPS, GAPED, EMOPICS, OASIS, etc. Pupillometry: In order to collect objective data on emotional bias, we will use pupillometry (or eye-tracking) during functional MRI sequences.
Behavioral task with emotional facial expressionsBehavioural
Description of the recognized emotion joy - sadness. Test to assess the hedonic value of an olfactory stimulus (10 min)
Biological investigationGenetic
Standard biological assessment, immuno-inflammatory profile and the association of 8 mRNA editing variants
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Depressed patients treated with Esketamin Receives: Behavioral: fMRI with emotional task and pupillometry; Behavioral: Behavioral task with emotional facial expressions; Genetic: Biological investigation |
| healthy volunteers | Other | Healthy subjects Receives: Behavioral: fMRI with emotional task and pupillometry; Behavioral: Behavioral task with emotional facial expressions; Genetic: Biological investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant difference in negative emotional bias measured by an image perception task before vs. after esketamine treatment
Comparison of the negative emotional bias measured by an image perception task (valence) before vs. after esketamine treatment [Baseline/1 month of treatment].
Measured: 1 month
Secondary outcomes (17)
Measure of the blood oxygenation level with the Blood-Oxygen-Level Dependent (BOLD) signal obtained at the functional magnetic resonance imaging (fMRI) task in depressed patients and in control subjects
The blood oxygenation level is measured thanks to the blood-oxygen-level dependent (BOLD) signal obtained at the fMRI task. This signal will be recorded in depressed patients and control subjects at baseline (Day 0) and at the end-of-study visit (6 weeks after Day 0) only for patients.
Measured: patients: at baseline (Day 0) and at the end-of study visit (6 weeks); control subjects: at baseline (Day 0)
Measure of the functional connectivity obtained at the resting-state functional magnetic resonance imaging (fMRI) in depressed patients and in control subjects
The basolateral amygdala/ventral hippocampus and basolateral amygdala/nucleus accumbens (BLA/vHPC, and BLA/Nac) functional connectivity obtained at the resting-state fMRI will be recorded in depressed patients and control subjects at baseline (Day 0) and at the end-of-study visit (6 weeks) only for patients
Measured: patients: at baseline (Day 0) and at the end-of study visit (6 weeks); control subjects: at baseline (Day 0)
Measure of the gray matter integrity obtained at the High-resolution anatomical (T1) magnetic resonance imaging (MRI) in depressed patients and in control subjects
The gray matter integrity obtained at the T1 (longitudinal relaxation time) MRI will be recorded in depressed patients and control subjects at baseline (Day 0) and at the end-of-study visit (6 weeks) only for patients
Measured: Patients: at baseline (Day 0) and at the end-of study visit (6 weeks); control subjects: at baseline (Day 0)
Measure of the white matter integrity obtained at the diffusion imaging in depressed patients and in control subjects
The white matter integrity obtained at the diffusion imaging will be recorded in depressed patients and control subjects at baseline (Day 0) and at the end-of-study visit (6 weeks) only for patients.
Measured: Patients: at baseline (Day 0) and at the end-of study visit (6 weeks); control subjects: at baseline (Day 0)
Measure of the depression severity in patients and control subjects thanks to the Montgomery-Åsberg Depression Rating Scale score
The depression severity will be assessed by the investigator with the Montgomery-Åsberg Depression Rating Scale (MADRS). The depression severity score will be then calculated. Score range (min - max): 0 - 60. Higher score relates to high depression severity. The questionnaire will be realized in depressed patients and control subjects at baseline (day 0) and throughout the study only for patients.
Measured: Patients: at baseline (Day 0), Day 7, Week 2 (2 times), Week 3 (2 times), Week 4 (2 times), Week 5 (2 times) and at the end-of-study visit (Week 6); control subjects: at baseline (Day 0)
Assessment of the emotional bias measured by an image perception task
The task used to calculate the emotional bias score involves presenting images to patients and control subjects, each of which has normative ratings for valence and arousal. The objective is to present ten images per block (9 blocks repeated 3 times) allowing for an evaluation of high, neutral or low emotional valence as well as high, low or medium arousal levels. The results for each participant will be summarized in a contingency table. The total emotional bias score (accuracy score) will be calculated at baseline (Day 0) for patients and control subjects and at the end-of-study (Week 6) only for patients.
Measured: Patients: at baseline (Day 0) and at the end-of-study visit (Week 6); control subjects: at baseline (Day 0)
Measure of the suicidality score in depressed patients thanks to the Columbia-Suicide Severity Rating Scale
The suicidality will be assessed by the investigator with the Columbia-Suicide Severity Rating Scale. The suicidality score will be then calculated. The suicidal ideation section is rated on a scale from 1 to 5, with increasing severity from passive thoughts of death to active suicidal intent with a plan. The Suicidal Behavior section assesses past suicide attempts or preparation, with a focus on the presence and severity of suicidal actions. There is no overall score in C-SSRS but the investigator will evaluate the individual's risk level at baseline (Day 0) and at the and-of-study visit (Week 6) in depressed patients.
Measured: At baseline (Day 0) and at the end-of-study visit (Week 6)
Measure of anhedonia score in depressed patients thanks to the Snaith-Hamilton Pleasure Scale
The Snaith-Hamilton Pleasure Scale (SHAPS) is used to measure the anhedonia. The total score ranges from 0 to 14 and is proportional to the degree of anhedonia. The questionnaire will be realized in depressed patients at baseline (day 0) and at the end-of-study visit in depressed patients.
Measured: At baseline (Day 0) and at the end-of-study visit (Week 6)
Measure of the anxiety score in depressed patients thanks to the Beck anxiety scale
The Beck anxiety scale consists of 21 self-reported items used to assess the intensity of physical and cognitive anxiety symptoms during the past week. The total score ranges from 0 to 63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63). The questionnaire will be realized in depressed patients at baseline (day 0) and at the end-of-study visit in depressed patients.
Measured: At baseline (Day 0) and at the end-of-study visit (Week 6)
Measure of the emotional reactivity in depressed patients and control subjects thanks to the Multidimensional Assessment of Thymic States scale
The MAThyS is a visual analogic scale consisting of 20 items. Score is determined line-by-line and varies from 0 to 10 for each line (centimeters). A score of 0 indicates an inhibition of the state evaluated by the item. A score of 5 indicates no change from the patient's usual state. A score of 10 corresponds to excitation for the evaluated state. An overall score between 0 and 200 is thus obtained. The questionnaire will be realized in depressed patients and control subjects at baseline (day 0) and throughout the study only for patients.
Measured: Patients: at baseline (Day 0), Day 7, Week 2 (2 times), Week 3 (2 times), Week 4 (2 times), Week 5 (2 times) and at the end-of-study visit (Week 6); control subjects: at baseline (Day 0).
Measure of the mania score in depressed patients and control subjects thanks to the Young Mania Rating Scale
The Young Mania Rating Scale (YMRS) has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. The total score ranges from 0 to 44 and is proportional to the degree of mania. The questionnaire will be assessed by the investigator at baseline (Day 0) in patients and control subjects as well as throughout the study for patients.
Measured: Patients: at baseline (Day 0), Day 7, Week 2 (2 times), Week 3 (2 times), Week 4 (2 times), Week 5 (2 times) and at the end-of-study visit (Week 6); control subjects: at baseline (Day 0)
Assessment of the severity and improvement of the clinical condition using the Clinical Global Impression Severity scale
The Clinical Global Impression scale (CGI) will be used by the physician to assess, with a 7-point scale, the depression severity of the patient's clinical condition, as well as, the improvement in the patient's clinical condition following treatment. Each of these scales is rated from 0 to 7. A score of 7 indicates the maximum level of severity of the patient's depressive state, and in the other case, a score of 7 indicates the maximum worsening of the patient's condition. The questionnaire will be assessed by the physician at baseline (Day 0) in patients and control subjects as well as throughout the study for patients.
Measured: Patients: at baseline (Day 0), Day 7, Week 2 (2 times), Week 3 (2 times), Week 4 (2 times), Week 5 (2 times) and at the end-of-study visit (Week 6); control subjects: at baseline (Day 0)
Assessment of the moral pain in depressed patients with the Psychological and Physical Pain Visual Analog Scale (PPP-VAS)
Patients complete the Psychological and Physical Pain Visual Analog Scale (PPP-VAS) at baseline (Day 0) and at the end-of-study visit (Week 6). The PPP-VAS consists of six dimensions presented as paper-based visual analog scales, which patients must annotate from 0 to 10, measuring current, mean and worst pain over the last 15 days, for physical then psychological pain (0 corresponding to no pain and 10 corresponding to the maximum imaginable pain).
Measured: At baseline (Day 0) and at the end-of-study visit (Week 6)
Assessment of the present-state dissociative symptoms score in depressed patients with the Clinician Administered Dissociative States Scale (CADSS)
The Clinician Administered Dissociative States Scale (CADSS) is administered by a physician to patients at Day 7, Week 2, Week 3, Week 4 and Week 5. This scale consists of 23 items, each rated from 0 to 4, with 0 indicating the absence of symptoms and 4 indicating the maximum severity of the symptom. The total score ranges from 0 (complete absence of dissociative symptoms) to a maximum score of 92 (highest level of dissociation).
Measured: At Day 7, Week 2 (2 times), Week 3 (2 times), Week 4 (2 times) and at Week 5 (2 times)
Measure of the cognitive complaints score with the Cognitive complaints in Bipolar disorder Rating Assessment (COBRA)
The cognitive complaints in Bipolar disorder Rating Assessment (COBRA) consists of 16 items that are rated using a 4-point scale, 0 = never, 1 = sometimes, 2 = often, and 3 = always. The COBRA total score is obtained when the scores of each item are added up (min-max score range: 0 - 48). The higher the score, the more subjective complaints. The COBRA is a self-questionnaire. Patients and control subjects will complete this questionnaire at baseline (Day 0) and patients will also complete it at the end-of-study visit (Week 6).
Measured: Patients: at baseline (Day 0) and at the end-of-study visit (Week 6); control subjects: at baseline (Day 0)
Assessment of the apathy score with the Starkstein Apathy Scale
The Starkstein Apathy Scale is a self-questionnaire that consists of 14 items that are rated using a 4-point scale (from 0 to 3). The total score is is obtained when scores of each item are added up (min-max score range: 0 - 42). The highest score is associated with the most significant apathy. Patients included in the current study will complete this questionnaire at baseline (Day 0) and at the end-of-study visit (Week 6).
Measured: At baseline (Day 0) and at the end-of-study visit (Week 6)
Analysis of immune-inflammatory markers and RNA editing markers in patients and control subjects
Blood samples are collected from patients at baseline (Day 0), at the second week and at the end-of-study visit (Week 6), as well as from healthy subjects at baseline (Day 0). These blood samples will allow for the analysis of immune-inflammatory markers as well as the analysis of RNA editing markers.
Measured: Patients: at baseline (Day 0), Week 2, at the end-of-study visit (Week 10); control subjects: at baseline (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start13 Mar 2023
- Primary completion13 Apr 2026 (estimated)
- Study completion13 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chantal Henry, Pr, Principal investigator, GHU Paris Psychiatry & Neurosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630065
- Sponsor's protocol ID
- D22-P015
- Acronym
- EMOKET
- Status last verified
- Oct 2024
- First submitted
- 26 Sep 2024
- Last updated
- 8 Oct 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 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Study of the Neural Circuits Underlying the Negative Emotional Bias of Depressive Disorders and Their Response to Ketamine
- ClinicalTrials.gov ID
- NCT06630065
- Acronym / sponsor ID
- EMOKET / D22-P015
- Conditions
- Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 13 Apr 2026 (estimated)
- Study completion
- 13 Apr 2026 (estimated)
- First posted
- 8 Oct 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.
Major depressive disorder is the leading cause of disability worldwide, affecting up to 300 million people each year, and one in five people will experience depression at least once in their lives. Emotional bias is an essential component of characterized depressive episodes, leading depressed patients to attribute a more negative valence to emotional stimuli.
On the basis of recent and robust neuroscientific data revisiting the role of the cerebral amygdala as an essential essential structure for encoding the negative and positive valences and of emotional stimuli, the team has shown in mice that a depressive phenotype induced by a chronic administration of corticosterone, a well-known model of depression, is associated with a change in hedonic value allocation, i.e. pleasant odors become less pleasant, and aversive odors become even more unpleasant, mimicking what happens in humans (identical data in humans).
It assumes that:
- There is a negative emotional bias in depressed patients compared with control subjects, evidenced by the assignment of more negative valences when viewing images.
- In depressed subjects, compared with controls subjects, there is greater activation of the basolateral amygdala/ventral hippocampus pathway (the level of imaging resolution of imaging does not allow to study the basolateral amygdala/central amygdala pathway in humans) and less of the basolateral amygdala/nucleus accumbens pathway.
- In depressed subjects, improvement in negative emotional bias correlated with a good response after after 4 weeks of treatment with esketamine (Spravato) measured by a 50% reduction in the Montgomery-Åsberg Depression Rating Scale.
- In depressed patients, early improvement of emotional bias (after a single administration) is predictive of response to treatment at 4 weeks.
- In depressed patients with a good response to a single 4-weeks course of esketamine (Spravato), a normalization of activation of basolateral amygdala/ventral hippocampus and basolateral amygdala/nucleus accumbens pathways is observed.
- Depressed subjects have different immunoinflammatory and RNA editing patterns different from control subjects.
- In depressed patients, clinical improvement correlates with normalization of patients; inflammatory profile and certain mRNA editing
- Some clinical features of major depressive disorder are associated with greater negative emotional bias significant
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Behavioral: fMRI with emotional task and pupillometry, Behavioral: Behavioral task with emotional facial expressions, Genetic: Biological investigationDepressed patients treated with Esketamin |
| healthy volunteers | Other | Behavioral: fMRI with emotional task and pupillometry, Behavioral: Behavioral task with emotional facial expressions, Genetic: Biological investigationHealthy subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age over 18
- Patient hospitalized or consulting at GHU Paris Psychiatrie et Neurosciences
- Patient with EDC (unipolar or bipolar) diagnosed according to the DSM-5 CRITERIA
- With MADRS score > 20
- For whom a course of esketamine has been decided by the psychiatrist of the patient
Key exclusion criteria (12 listed)
- Psychiatric comorbidities: schizophrenic disorder or schizoaffective disorder, history of recreational use of ketamine
- Protected adults, persons under legal protection
- Contraindications to MRI, including refusal to be informed of the discovery of a clinically significant abnormality on MRI
- Pregnant or breast-feeding women
- Usual contraindications to esketamine :
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 |
|---|---|---|
| fMRI with emotional task and pupillometryAnatomical and functional magnetic resonance imaging (fMRI) imaging sequences with pupillometry (~90 min) A functional sequence - Task (~20min): * Emotional task in fMRI: Instructions: simply look images, then evaluate the emotions triggered at the end of each block; rating on a valence and intensity scale and intensity (arousal) scale. * Experimental conditions: positive, negative and neutral * Paradigm: block validated image banks: IAPS, GAPED, EMOPICS, OASIS, etc. Pupillometry: In order to collect objective data on emotional bias, we will use pupillometry (or eye-tracking) during functional MRI sequences. | Behavioural | Patients, healthy volunteers |
| Behavioral task with emotional facial expressionsDescription of the recognized emotion joy - sadness. Test to assess the hedonic value of an olfactory stimulus (10 min) | Behavioural | Patients, healthy volunteers |
| Biological investigationStandard biological assessment, immuno-inflammatory profile and the association of 8 mRNA editing variants | Genetic | Patients, healthy volunteers |
Primary outcome
Significant difference in negative emotional bias measured by an image perception task before vs. after esketamine treatment
Time frame: 1 month
Comparison of the negative emotional bias measured by an image perception task (valence) before vs. after esketamine treatment [Baseline/1 month of treatment].
17 secondary outcomes
Measure of the blood oxygenation level with the Blood-Oxygen-Level Dependent (BOLD) signal obtained at the functional magnetic resonance imaging (fMRI) task in depressed patients and in control subjects
Time frame: patients: at baseline (Day 0) and at the end-of study visit (6 weeks); control subjects: at baseline (Day 0)
Measure of the functional connectivity obtained at the resting-state functional magnetic resonance imaging (fMRI) in depressed patients and in control subjects
Time frame: patients: at baseline (Day 0) and at the end-of study visit (6 weeks); control subjects: at baseline (Day 0)
Measure of the gray matter integrity obtained at the High-resolution anatomical (T1) magnetic resonance imaging (MRI) in depressed patients and in control subjects
Time frame: Patients: at baseline (Day 0) and at the end-of study visit (6 weeks); control subjects: at baseline (Day 0)
Measure of the white matter integrity obtained at the diffusion imaging in depressed patients and in control subjects
Time frame: Patients: at baseline (Day 0) and at the end-of study visit (6 weeks); control subjects: at baseline (Day 0)
Measure of the depression severity in patients and control subjects thanks to the Montgomery-Åsberg Depression Rating Scale score
Time frame: Patients: at baseline (Day 0), Day 7, Week 2 (2 times), Week 3 (2 times), Week 4 (2 times), Week 5 (2 times) and at the end-of-study visit (Week 6); control subjects: at baseline (Day 0)
Assessment of the emotional bias measured by an image perception task
Time frame: Patients: at baseline (Day 0) and at the end-of-study visit (Week 6); control subjects: at baseline (Day 0)
Measure of the suicidality score in depressed patients thanks to the Columbia-Suicide Severity Rating Scale
Time frame: At baseline (Day 0) and at the end-of-study visit (Week 6)
Measure of anhedonia score in depressed patients thanks to the Snaith-Hamilton Pleasure Scale
Time frame: At baseline (Day 0) and at the end-of-study visit (Week 6)
Measure of the anxiety score in depressed patients thanks to the Beck anxiety scale
Time frame: At baseline (Day 0) and at the end-of-study visit (Week 6)
Measure of the emotional reactivity in depressed patients and control subjects thanks to the Multidimensional Assessment of Thymic States scale
Time frame: Patients: at baseline (Day 0), Day 7, Week 2 (2 times), Week 3 (2 times), Week 4 (2 times), Week 5 (2 times) and at the end-of-study visit (Week 6); control subjects: at baseline (Day 0).
Measure of the mania score in depressed patients and control subjects thanks to the Young Mania Rating Scale
Time frame: Patients: at baseline (Day 0), Day 7, Week 2 (2 times), Week 3 (2 times), Week 4 (2 times), Week 5 (2 times) and at the end-of-study visit (Week 6); control subjects: at baseline (Day 0)
Assessment of the severity and improvement of the clinical condition using the Clinical Global Impression Severity scale
Time frame: Patients: at baseline (Day 0), Day 7, Week 2 (2 times), Week 3 (2 times), Week 4 (2 times), Week 5 (2 times) and at the end-of-study visit (Week 6); control subjects: at baseline (Day 0)
Assessment of the moral pain in depressed patients with the Psychological and Physical Pain Visual Analog Scale (PPP-VAS)
Time frame: At baseline (Day 0) and at the end-of-study visit (Week 6)
Assessment of the present-state dissociative symptoms score in depressed patients with the Clinician Administered Dissociative States Scale (CADSS)
Time frame: At Day 7, Week 2 (2 times), Week 3 (2 times), Week 4 (2 times) and at Week 5 (2 times)
Measure of the cognitive complaints score with the Cognitive complaints in Bipolar disorder Rating Assessment (COBRA)
Time frame: Patients: at baseline (Day 0) and at the end-of-study visit (Week 6); control subjects: at baseline (Day 0)
Assessment of the apathy score with the Starkstein Apathy Scale
Time frame: At baseline (Day 0) and at the end-of-study visit (Week 6)
Analysis of immune-inflammatory markers and RNA editing markers in patients and control subjects
Time frame: Patients: at baseline (Day 0), Week 2, at the end-of-study visit (Week 10); control subjects: at baseline (Day 0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 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.
Chantal Henry, Pr principal investigator
GHU Paris Psychiatry & Neurosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI with emotional task and pupillometry, Behavioral task with emotional facial expressions and Biological investigation in people with Depressive Disorder, run by Centre Hospitalier St Anne 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 10 inclusion and 12 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 8 Oct 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 Chantal Henry, Pr (0145658452, ch.henry@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant difference in negative emotional bias measured by an image perception task before vs. after esketamine treatment (time frame: 1 month). 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 8 Oct 2024.