Depression - Major Depressive DisorderPhase 2PSILOTRAZNCT07210112
Efficacy of Psilocybin and Trazodone Combination in Treatment-resistant Depression: a Randomized Controlled Proof-of-concept Study (PSILOTRAZ)
A Phase 2 study testing Psilocybin 25 mg per os, Trazodone 5mg and Trazodone 30 mg in people with Depression - Major Depressive Disorder and Treatment-resistant Depression (TRD), run by Centre Hospitalier St Anne at 1 site in France.
Trial summary
Psilocybin, a serotonin receptor agonist in the brain, significantly and quickly improves depressive symptoms while inducing profound acute subjective effects. The benefit-risk ratio of psilocybin in treatment-resistant depression seems favorable, but needs to be confirmed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
- What is being tested?
- Psilocybin 25 mg per os, Trazodone 5mg and Trazodone 30 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2026to 30 Jun 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patient with major depressive episode without psychotic features according to DSM-5 criteria;
- Treatment-resistant depressive episode, i.e. failure to respond to at least two lines of antidepressant medication at an adequate dose and for a sufficient period of time (6 weeks according to the MGH-ATRQ);
- MADRS ≥ 20;
- Written signed informed consent;
- Patient covered by the social security system.
Who cannot join
- Psychiatric comorbidities known from medical history or identified during inclusion assessment:
- Bipolar disorder;
- Schizophrenia and psychosis;
- Personal or family history of psychotic disorder;
- History of personality disorder;
- Post-traumatic stress disorder, obsessive-compulsive disorder, eating disorders;
Show all 31Show fewer
- Alcohol or substance use disorder in past 12 months or positive urine toxins at time of assessment;
- Significant suicide risk, as defined by: (a) suicidal ideation as indicated by items 4 or 5 on the C-SSRS within the past six months, at Screening, during the Screening Period, or at Baseline (b) demonstrating suicidal behaviors in the past six months, or; (c). clinical assessment of significant suicidal risk or risk of self-injury during participant interview;
- Patient with a psychiatric decompensation following a previous use of psychedelic substance like LSD;
- Comorbidities or somatic specificities:
- Pregnancy and breastfeeding women;
- Cardiovascular history (myocardial infarction, stroke, heart rhythm disorder, uncontrolled hypertension, QT interval prolongation, tachycardia and poor cardiovascular health);
- Uncontrolled diabetes;
- Uncontrolled thyroid disorder;
- Epilepsy;
- Parkinson's disease treated by selegiline or levodopa;
- HIV treated by ritonavir and indinavir;
- Active infection treated by erythromycin;
- Fungal infection treated by ketoconazole and itraconazole;
- Contraindications to MRI;
- Concomitant therapies:
- 5-HT antagonist treatment2A (including quetiapine, olanzapine, aripiprazole);
- Lithium treatment;
- Treatment with buprenorphine or opioids, clonidine, methyldopa, digoxin, Monoamine oxidase inhibitors (MAOI), aldehyde dehydrogenase (ALDH) inhibitors and alcohol dehydrogenase (ADH) inhibitors, St. John's Wort, or warfarin should be discontinued completely before study drug administration;
- Use of electroconvulsive therapy and/or transcranial magnetic stimulation, during the current depressive episode; or lifetime vagus nerve stimulation, deep brain stimulation, and/or ablative neurosurgery;
- Use of psychedelics (psilocybin, lysergic acid, ayahuasca, mescaline and derivatives) during current episode;
- Legal status:
- Persons deprived of their liberty by judicial or administrative decision, persons under compulsory psychiatric care;
- Persons under legal protection or unable to give consent;
- Other:
- Any clinical manifestation which, in the opinion of the investigator, may interfere with the interpretation of study results or constitute a health risk to the participant if he or she participates in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
GHU Paris Psychiatrie and Neurosciences
Paris, 75014
Lucie BERKOVITCH, MD, +33 145657481, l.berkovitch@ghu-paris.fr
Cécile BULTEZ, MSc, cecile.bultez@ghu-paris.fr
About this study
Psilocybin, a serotonin receptor agonist in the brain, significantly and quickly improves depressive symptoms while inducing profound acute subjective effects.
The benefit-risk ratio of psilocybin in treatment-resistant depression seems favorable, but needs to be confirmed. Moreover, the role of 5-HT2A receptors, involved in the psychedelic experience, on the therapeutic efficacy of psilocybin is still poorly understood. For example, pre-administration of trazodone, a 5-HT2A antagonist antidepressant, could annihilate the acute subjective effects of psilocybin without altering its beneficial effects (Rosenblat et al., 2023). We intend to test this hypothesis by comparing, in a randomized, double-blind, placebo-controlled study, the effect of two possible doses of trazodone (total or partial occupancy of 5-HT2A receptors) on the benefit/risk ratio of psilocybin.
We hypothesize that the therapeutic effects of psilocybin are partially independent of 5-HT2A receptor activation and thus persist even after total or partial neutralization of its acute subjective effects.
Read the detailed description
Treatment-resistant depression (TRD) is a frequent and potentially severe psychiatric disorder characterized by specific neurocognitive impairments. It has previously been demonstrated that psilocybin, a serotonin receptor agonist in the brain, significantly and quickly improved depressive symptoms while inducing profound acute subjective effects.
The benefit-risk ratio of psilocybin in TRD seems favorable, but needs to be confirmed. Moreover, the role of 5-HT2A receptors, involved in the psychedelic experience, on the therapeutic efficacy of psilocybin is still poorly understood. For example, pre-administration of trazodone, a 5-HT2A antagonist antidepressant, could annihilate the acute subjective effects of psilocybin without altering its beneficial effects (Rosenblat et al., 2023). We intend to test this hypothesis in a randomized, double-blind, placebo-controlled phase II, monocentric, 4 parallel-group proof-of-concept study involving 112 adult subjects with a depressive episode who had failed to respond to at least two lines of antidepressant treatment. Patients will be randomized in a 1:1:1:1 ratio to one of the following treatment groups:
- Group 1: Psilocybin PEX010 (25 mg) + trazodone placebo (pharmaceutical master preparation prepared according to GPP)
- Group 2: Psilocybin PEX010 (25 mg) + trazodone 5 mg
- Group 3: Psilocybin PEX010 (25 mg) + trazodone 30 mg
- Group 4: PCB2 (Placebo of PEX010 (25)) + trazodone 30 mg Stratification factors: gender (M/F).
- Being tested
- Psilocybin 25 mg per os, Trazodone 5mg, Trazodone 30 mg, Placebo of psilocybin, Placebo of trazodone
- Keywords
- psilocybin, trazodone, TRD, RCT
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin 25 mg per osDrug
Caps of psilocybin administered orally once (V3) under medical and psychologist supervision in group 1, 2, and 3 and in an open-label setting for group 4
Trazodone 5mgDrug
Oral preparation of trazodone administered orally once (V3) with psilocybin in Group 2
Trazodone 30 mgDrug
Oral preparation of trazodone administered orally once (V3) with psilocybin in Groups 3 \& 4
Placebo of psilocybinDrug
Caps of psilocybin placebo will be administered at V3 in group 4
Placebo of trazodoneDrug
A placebo of trazodone will be administered orally at V3 in group 1
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Psilocybin PEX010 25 mg + trazodone placebo (pharmaceutical master preparation prepared according to GPP) Receives: Drug: Psilocybin 25 mg per os; Drug: Placebo of trazodone |
| Group 2 | Experimental | Psilocybin PEX010 (25 mg) + trazodone 5 mg Receives: Drug: Psilocybin 25 mg per os; Drug: Trazodone 5mg |
| Group 3 | Experimental | Psilocybin PEX010 (25 mg) + trazodone 30 mg Receives: Drug: Psilocybin 25 mg per os; Drug: Trazodone 30 mg |
| Group 4 | Placebo comparator | PCB2 (Placebo of PEX010 (25)) + trazodone 30 mg Receives: Drug: Trazodone 30 mg; Drug: Placebo of psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the mean score of Montgomery-Åsberg Depression Rating Scale (MADRS) at 1 month
Mean difference of MADRS scores between one month and Baseline, between the following groups: psilocybin + trazodone 30 mg (Group 3) and placebo + trazodone (Group 4).
Measured: Baseline, Month 1
Secondary outcomes (16)
Change from Baseline in the MADRS scores at Month1 in the Groups 1, 2 and 4
MADRS scores at Baseline and Month 1 in the Groups 1, 2 and 4
Measured: Baseline and Month 1
Change from Inclusion in the MADRS scores at Baseline, Day0 H7, Day 1, Day 7, Month 2 and Month 3 in each group
MADRS scores at Inclusion, Baseline, Day0 H7, Day 1, Day 7, Month 2 and Month 3 in each group
Measured: Inclusion, Baseline, Day0 H7, Day 1, Day 7, Month 2 and Month 3
Change from Inclusion in the Beck Depression Inventory (BDI-II) scores at Baseline, Day0 H7, Day 1, Day 7, Month 1, Month 2 and Month 3 in each group
BDI-II scores at Inclusion, Baseline, Day0 H7, Day 1, Day 7, Month 1, Month 2 and Month 3 in each group
Measured: Inclusion, Baseline, Day0 H7, Day 1, Day 7, Month 1, Month 2 and Month 3
Change from Inclusion in the Columbia-Suicide Severity Rating Scale (C-SSRS) scores at Baseline, Day0 H7, Day 1, Day 7, Month 1, Month 2 and Month 3 in each group
C-SSRS scores at Inclusion, Baseline, Day0 H7, Day 1, Day 7, Month 1, Month 2 and Month 3 in each group
Measured: Inclusion, Baseline, Day0 H7, Day 1, Day 7, Month 1, Month 2 and Month 3
Response rate
Proportion of patients with 50% reduction in MADRS scores in each group at Day 7, Month 1, Month 2 and Month 3 compared to Baseline
Measured: Baseline, Day 7, Month 1, Month 2 and Month 3
Remission rate
Remission rates defined as the proportion of patients with a MADRS score <10 in each group at Day 7, Month 1, Month 2 and Month 3 compared to Baseline score
Measured: Baseline, Day 7, Month 1, Month 2 and Month 3
Number of adverse events observed including vital signs and clinical laboratory abnormalities
Side effects in all groups between study drug administration at Day 0, Day 1, Day 7, Month 1, Month 2 and Month 3 including vital signs worsening and biological adverse events (laboratory exams worsening)
Measured: Day 0, Day 1, Day 7, Month 1, Month 2, Month 3
Change from Inclusion in the mean YMRS at Baseline, Day 0 H7, Day 1, Day 7, Month 1, Month 2 and Month 3
Mean YMRS scores at Inclusion, Baseline, Day 0 H7, Day 1, Day 7, Month 1, Month 2 and Month 3 in each group
Measured: Inclusion, Baseline, Day 0 H7, Day 1, Day 7, Month 1, Month 2, Month 3
Proportion of patients with a new antidepressant after study treatment administration (Day 0)
Proportion of patients with an introduction of a new antidepressant after Day 0 in each group
Measured: From Day 0 to end of study
Mean score of visual analog scale (VAS) of patients' drug acute subjective effects at Day 0
Measured: Day 0
Mean scores of Mystical Experience Questionnaire (MEQ30) at Day 0
Measured: Day 0
Mean score of 5-Dimensional Altered States of Consciousness (5D-ASC) at Day 0
Measured: Day 0
Mean score of Stanford Expectations of Treatment Scale (SETS) at Baseline
Measured: Baseline
Mean score of the Credibility/Expectancy Questionnaire (CEQ) at Baseline
Measured: Baseline
Change from Inclusion in the mean score of Quality of Life in Depression Scale (QLDS) at Baseline, Day 7, Month 1, Month 2 and Month 3
Measured: Inclusion, Baseline, Day 7, Month 1, Month 2 and Month 3
Change in mean reaction time from Baseline at Day 0, Day 7, Month 1and Month 3
Measured: Baseline, Day 0, Day 7, Month 1, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start30 Jun 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucie BERKOVITCH, MD, Principal investigator, GHU Paris Psychiatrie and Neurosciences - Neuromodulation Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210112
- Sponsor's protocol ID
- D24-P003
- Acronym
- PSILOTRAZ
- Status last verified
- Jun 2026
- First submitted
- 29 Sep 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Psilocybin and Trazodone Combination in Treatment-resistant Depression: a Randomized Controlled Proof-of-concept Study (PSILOTRAZ)
- ClinicalTrials.gov ID
- NCT07210112
- Acronym / sponsor ID
- PSILOTRAZ / D24-P003
- Keywords
- psilocybin, trazodone, TRD, RCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 7 Oct 2025 (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.
Psilocybin, a serotonin receptor agonist in the brain, significantly and quickly improves depressive symptoms while inducing profound acute subjective effects.
The benefit-risk ratio of psilocybin in treatment-resistant depression seems favorable, but needs to be confirmed. Moreover, the role of 5-HT2A receptors, involved in the psychedelic experience, on the therapeutic efficacy of psilocybin is still poorly understood. For example, pre-administration of trazodone, a 5-HT2A antagonist antidepressant, could annihilate the acute subjective effects of psilocybin without altering its beneficial effects (Rosenblat et al., 2023). We intend to test this hypothesis by comparing, in a randomized, double-blind, placebo-controlled study, the effect of two possible doses of trazodone (total or partial occupancy of 5-HT2A receptors) on the benefit/risk ratio of psilocybin.
We hypothesize that the therapeutic effects of psilocybin are partially independent of 5-HT2A receptor activation and thus persist even after total or partial neutralization of its acute subjective effects.
Detailed description
Treatment-resistant depression (TRD) is a frequent and potentially severe psychiatric disorder characterized by specific neurocognitive impairments. It has previously been demonstrated that psilocybin, a serotonin receptor agonist in the brain, significantly and quickly improved depressive symptoms while inducing profound acute subjective effects.
The benefit-risk ratio of psilocybin in TRD seems favorable, but needs to be confirmed. Moreover, the role of 5-HT2A receptors, involved in the psychedelic experience, on the therapeutic efficacy of psilocybin is still poorly understood. For example, pre-administration of trazodone, a 5-HT2A antagonist antidepressant, could annihilate the acute subjective effects of psilocybin without altering its beneficial effects (Rosenblat et al., 2023). We intend to test this hypothesis in a randomized, double-blind, placebo-controlled phase II, monocentric, 4 parallel-group proof-of-concept study involving 112 adult subjects with a depressive episode who had failed to respond to at least two lines of antidepressant treatment. Patients will be randomized in a 1:1:1:1 ratio to one of the following treatment groups:
- Group 1: Psilocybin PEX010 (25 mg) + trazodone placebo (pharmaceutical master preparation prepared according to GPP)
- Group 2: Psilocybin PEX010 (25 mg) + trazodone 5 mg
- Group 3: Psilocybin PEX010 (25 mg) + trazodone 30 mg
- Group 4: PCB2 (Placebo of PEX010 (25)) + trazodone 30 mg Stratification factors: gender (M/F).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Psilocybin 25 mg per os, Drug: Placebo of trazodonePsilocybin PEX010 25 mg + trazodone placebo (pharmaceutical master preparation prepared according to GPP) |
| Group 2 | Experimental | Drug: Psilocybin 25 mg per os, Drug: Trazodone 5mgPsilocybin PEX010 (25 mg) + trazodone 5 mg |
| Group 3 | Experimental | Drug: Psilocybin 25 mg per os, Drug: Trazodone 30 mgPsilocybin PEX010 (25 mg) + trazodone 30 mg |
| Group 4 | Placebo comparator | Drug: Trazodone 30 mg, Drug: Placebo of psilocybinPCB2 (Placebo of PEX010 (25)) + trazodone 30 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with major depressive episode without psychotic features according to DSM-5 criteria;
- Treatment-resistant depressive episode, i.e. failure to respond to at least two lines of antidepressant medication at an adequate dose and for a sufficient period of time (6 weeks according to the MGH-ATRQ);
- MADRS ≥ 20;
- Written signed informed consent;
- Patient covered by the social security system.
Key exclusion criteria (31 listed)
- Psychiatric comorbidities known from medical history or identified during inclusion assessment:
- Bipolar disorder;
- Schizophrenia and psychosis;
- Personal or family history of psychotic disorder;
- History of personality disorder;
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 |
|---|---|---|
| Psilocybin 25 mg per osCaps of psilocybin administered orally once (V3) under medical and psychologist supervision in group 1, 2, and 3 and in an open-label setting for group 4 | Drug | Group 1, Group 2, Group 3 |
| Trazodone 5mgOral preparation of trazodone administered orally once (V3) with psilocybin in Group 2 | Drug | Group 2 |
| Trazodone 30 mgOral preparation of trazodone administered orally once (V3) with psilocybin in Groups 3 \& 4 | Drug | Group 3, Group 4 |
| Placebo of psilocybinCaps of psilocybin placebo will be administered at V3 in group 4 | Drug | Group 4 |
| Placebo of trazodoneA placebo of trazodone will be administered orally at V3 in group 1 | Drug | Group 1 |
Primary outcome
Change from Baseline in the mean score of Montgomery-Åsberg Depression Rating Scale (MADRS) at 1 month
Time frame: Baseline, Month 1
Mean difference of MADRS scores between one month and Baseline, between the following groups: psilocybin + trazodone 30 mg (Group 3) and placebo + trazodone (Group 4).
16 secondary outcomes
Change from Baseline in the MADRS scores at Month1 in the Groups 1, 2 and 4
Time frame: Baseline and Month 1
Change from Inclusion in the MADRS scores at Baseline, Day0 H7, Day 1, Day 7, Month 2 and Month 3 in each group
Time frame: Inclusion, Baseline, Day0 H7, Day 1, Day 7, Month 2 and Month 3
Change from Inclusion in the Beck Depression Inventory (BDI-II) scores at Baseline, Day0 H7, Day 1, Day 7, Month 1, Month 2 and Month 3 in each group
Time frame: Inclusion, Baseline, Day0 H7, Day 1, Day 7, Month 1, Month 2 and Month 3
Change from Inclusion in the Columbia-Suicide Severity Rating Scale (C-SSRS) scores at Baseline, Day0 H7, Day 1, Day 7, Month 1, Month 2 and Month 3 in each group
Time frame: Inclusion, Baseline, Day0 H7, Day 1, Day 7, Month 1, Month 2 and Month 3
Response rate
Time frame: Baseline, Day 7, Month 1, Month 2 and Month 3
Remission rate
Time frame: Baseline, Day 7, Month 1, Month 2 and Month 3
Number of adverse events observed including vital signs and clinical laboratory abnormalities
Time frame: Day 0, Day 1, Day 7, Month 1, Month 2, Month 3
Change from Inclusion in the mean YMRS at Baseline, Day 0 H7, Day 1, Day 7, Month 1, Month 2 and Month 3
Time frame: Inclusion, Baseline, Day 0 H7, Day 1, Day 7, Month 1, Month 2, Month 3
Proportion of patients with a new antidepressant after study treatment administration (Day 0)
Time frame: From Day 0 to end of study
Mean score of visual analog scale (VAS) of patients' drug acute subjective effects at Day 0
Time frame: Day 0
Mean scores of Mystical Experience Questionnaire (MEQ30) at Day 0
Time frame: Day 0
Mean score of 5-Dimensional Altered States of Consciousness (5D-ASC) at Day 0
Time frame: Day 0
Mean score of Stanford Expectations of Treatment Scale (SETS) at Baseline
Time frame: Baseline
Mean score of the Credibility/Expectancy Questionnaire (CEQ) at Baseline
Time frame: Baseline
Change from Inclusion in the mean score of Quality of Life in Depression Scale (QLDS) at Baseline, Day 7, Month 1, Month 2 and Month 3
Time frame: Inclusion, Baseline, Day 7, Month 1, Month 2 and Month 3
Change in mean reaction time from Baseline at Day 0, Day 7, Month 1and Month 3
Time frame: Baseline, Day 0, Day 7, Month 1, Month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Lucie BERKOVITCH, MD principal investigator
GHU Paris Psychiatrie and Neurosciences - Neuromodulation Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin 25 mg per os, Trazodone 5mg and Trazodone 30 mg in people with Depression - Major Depressive Disorder and Treatment-resistant Depression (TRD), 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 5 inclusion and 31 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucie BERKOVITCH, MD (+33 145657481, l.berkovitch@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the mean score of Montgomery-Åsberg Depression Rating Scale (MADRS) at 1 month (time frame: Baseline, Month 1). 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 21 Sep 2026.