Depressive DisorderPSILODACNCT06650800
Effect of Psilocybin on the Positive Valence System in Treatment-resistant Depression
A study testing Psilocybin and MRI in people with Depressive Disorder and Depressive Disorder, Treatment-Resistant, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The study hypothesis is that the antidepressant effect of psilocybin is mediated by a normalization of the functioning of the positive valence system. Depressive states, especially moderate to severe depressions that associate a certain level of anhedonia, produce an overvaluation of the cost of efforts and an… Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Depressive Disorder, Depressive Disorder, Treatment-Resistant, Hallucinogens
- What is being tested?
- Psilocybin and MRI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 19 Nov 2024to 26 Jun 2025
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- Patient with a current DSM-IV diagnosis of moderate or severe major depressive episode (MDE) without psychotic features (based on clinical assessment and confirmed by the MINI interview and the QIDS).
- Patient who has not responded to at least two antidepressant treatments of different classes, administered appropriately in terms of dose and duration, for a moderate to severe major depressive episode.
- Patients receiving antidepressant treatment of the SSRI (Selective Serotonin Reuptake Inhibitors) or SNRI (Serotonin Norepinephrine Reuptake Inhibitors) classes may maintain this treatment for the duration of the trial, without modification • Patient with a score > 10 on the QIDS scale.
- Patient available for a 4-month follow-up.
- Patient able to speak and understand French easily.
Who cannot join
- The patient is participating in a medical product-based interventional study, or is in a period of exclusion determined by a previous study
- Patient unable to express consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient with allergy, hypersensitivity or other adverse reaction to previous use of psilocybin or other hallucinogens.
- Patient who has used hallucinogenic substances (excluding cannabis) more than 5 times in his/her lifetime or at any time in the last twelve months.
Show all 26Show fewer
- Patient on medication or illicit substances likely to interfere with the effects of psychedelics (urine analysis and breathalyzer on D0).
- Patient with regular consumption of alcoholic beverages (>20 drinks/week)
- Any other major clinically significant concomitant disease that, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a risk to the health of the participant, if he or she participates in the study
- Patient with a prolonged QTc interval (interval corrected by the Fridericia formula >450 ms for men and >470 ms for women
- Participant planning to donate sperm within three months of psilocybin administration
- Female participant having sexual intercourse that could result in pregnancy and not agreeing to use a highly effective contraceptive method (combined hormonal contraception (containing estrogen and progestin), contraception associated with inhibition of ovulation, hormonal progestin-only contraception associated with inhibition of ovulation, intrauterine device intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, and sexual abstinence) throughout their participation in the study and for at least three months after psilocybin administration.
- Positive serum pregnancy test at inclusion for participants of childbearing potential. NB: a urine pregnancy test will also be performed on the day of psilocybin administration.
- Pregnant patient (confirmed by pregnancy test), parturient or breastfeeding, or wishing to become pregnant during their participation in the study
- Active substance dependence according to the MINI questionnaire (excluding tobacco).
- Patient whose psychotropic treatment (anxiolytics, antipsychotics, hypnotics, mood stabilizers) has been modified in the last month.
- Patient on antidepressant treatment other than SSRIs or SNRIs. (Antidepressant treatments other than SSRIs or SNRIs are prohibited in the trial. Patients receiving antidepressant treatment of a different class (MAOIs, tricyclics, tetracyclics), alone or in combination, will not be included in the study).
- Patient suffering from intellectual disability (IQ less than or equal to 75).
- Patient with a history of bipolar disorder, schizophrenia, schizoaffective disorder or psychosis not otherwise specified during life.
- Patient with a family history of schizophrenia, schizoaffective disorder or bipolar disorder type 1 in first or second degree relatives.
- Patient who has started psychotherapy in the 30 days preceding the screening visit, or whose psychotherapy is likely to undergo changes during the clinical trial.
- Patient who has received in the last 6 months treatments such as: ECT, vagus nerve stimulation, deep brain stimulation, transcranial magnetic stimulation.
- Patient with any disease or unstable physical condition determined by clinical examination, history or laboratory tests (ECG, blood test at inclusion) These pathologies include cardiovascular comorbidities: history of stroke, myocardial infarction, heart failure, intracranial hypertension, arrhythmia, uncontrolled hypertension (greater than 140/90 mmHg at screening), tachycardia (resting heart rate > 100 beats per minute); organic epileptic syndrome and active neurological comorbidities; endocrine pathologies (dysthyroidism and adrenals, type I diabetes or insulin-requiring type II diabetes, history of severe hypoglycemia requiring hospitalization); significant impairment of liver function; glaucoma; symptomatic prostatic hypertrophy or bladder neck obstruction; renal failure; respiratory failure; presence of fever or inflammatory syndrome.
- Patient with contraindications to magnetic resonance imaging: patients with a metallic foreign body, pacemaker, neurostimulator or any electronic medical equipment implanted in a non-removable manner, implantable cardiac defibrillators, prostheses, transdermal patches (placed under the skin), catheters (tubes introduced into a vessel or organ), implantable pumps, artificial heart valves, implants to treat deafness.
- Patient at moderate or severe risk of suicide based on clinical judgment (according to the MINI Suicidality Module).
- Patient at high risk of adverse emotional or behavioral reaction based on the investigator's clinical assessment (e.g., severe personality disorder, antisocial behavior, severe current stressors, lack of significant social support, or any psychotic symptoms identified during interviews).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Psilocybin on the Positive Valence System in Treatment-resistant Depression: a Pilot Clinical Neuroimaging Study
The study hypothesis is that the antidepressant effect of psilocybin is mediated by a normalization of the functioning of the positive valence system. Depressive states, especially moderate to severe depressions that associate a certain level of anhedonia, produce an overvaluation of the cost of efforts and an infra-evaluation of the possible rewards derived from an action. Psilocybin would reduce anhedonia and the cost of efforts, facilitating the anticipation of reward. Thus, the antidepressant effect of psilocybin would be mediated by a greater anticipation of rewards (reduction of anhedonia) and a more optimistic estimation of the results of efforts (increase in motivation). Psilocybin-induced changes in the positive valence system will be observable on brain MRI images, particularly in the effort evaluation circuits: basolateral amygdala, dorsal anterior cingulate cortex, ventral pallidum, ventral striatum (VS), ventral tegmental area (VTA). The mesolimbic circuit (VS, VTA) is the anatomical substrate of anticipation of rewarding stimuli (food, sex, drugs). The amygdala also fulfills an associative function between environmental cues and rewarding stimuli. Structural and functional alterations in this circuit are associated with depressive symptoms such as anhedonia or distortions in the perception and memories of rewards. This hypothesis will be tested on a population of patients with moderate or severe depressive symptoms who meet the criteria for TRD.
Read the detailed description
Depressive disorders are strongly associated with suicide risk and are the leading cause of disability in the world. Psilocybin is a natural alkaloid with psychedelic and hallucinogenic effects, produced by its active metabolite: psilocin. In recent years, there has been a resurgence of research aimed at using psilocybin in the treatment of psychiatric disorders, and in particular depression, combined or not with various psychotherapeutic programs. Psilocybin-assisted therapy is effective in treating cancer-associated depression and resistant depression. The Federal Drug Administration (FDA) has designated it as a "Breakthrough Therapy" in the treatment of treatment-resistant depression (TRD). Most researchers consider that the antidepressant effects of psilocybin are associated with the activation of the serotonin 5-HT2a receptor, with acute neuromodulation effects that modify the connectivity of cortico-striatal loops, but the mechanisms supporting this effect are unknown. The purpose of this study is to verify whether the antidepressant action of psilocybin is associated with an activation of the brain areas involved in the positive valence system, by comparing the activity of the neural circuits responsible for the evaluation of effort before and after taking psilocybin. The correlations between the activation of brain areas and the depression severity, behavioral activation and anhedonia scores will help establish a link with the response to treatment. Finally, the study authors wish to test the feasibility of a study with psilocybin in a French clinical population.
- Conditions
- Depressive Disorder, Depressive Disorder, Treatment-Resistant, Hallucinogens, Reinforcement, Psychology
- Being tested
- Psilocybin, MRI
- Medical subject headings
- Depressive Disorder, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Single-dose psilocybin administration: oral ingestion of one 25 mg capsule
MRIOther
1.5 hour brain MRI before and after psilocybin administration
| Study group | Role | What they receive |
|---|---|---|
| Patient with major depressive episode | Experimental | Not described Receives: Drug: Psilocybin; Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity of the neural circuits responsible for the evaluation of effort before taking psilocybin
Brain activity measured by fMRI at resting state and during Effort Expenditure for Rewards Task in the basolateral amygdala, dorsal anterior cingulate cortex, ventral pallidum, ventral striatum and ventral tegmental area
Measured: Two days before administration of psilocybin
Activity of the neural circuits responsible for the evaluation of effort after taking psilocybin
Brain activity measured by fMRI at resting state and during Effort Expenditure for Rewards Task in the basolateral amygdala, dorsal anterior cingulate cortex, ventral pallidum, ventral striatum and ventral tegmental area
Measured: Five days after administration of psilocybin
Secondary outcomes (19)
Effect of a single-dose administration of psilocybin on self-reported treatment-resistant depression
Quick Inventory of Depressive Symptomatology (QIDS-SR16); 16 items rated from 0 to 3. Total scores range from 0 to 27, with scores of 11 to 15 indicating moderate depression, 16 to 20 reflecting severe depression, and total scores greater than 21 indicating very severe depression.
Measured: Day 0
Effect of a single-dose administration of psilocybin on self-reported treatment-resistant depression
Quick Inventory of Depressive Symptomatology (QIDS-SR16); 16 items rated from 0 to 3. Total scores range from 0 to 27, with scores of 11 to 15 indicating moderate depression, 16 to 20 reflecting severe depression, and total scores greater than 21 indicating very severe depression.
Measured: Day 4
Effect of a single-dose administration of psilocybin on self-reported treatment-resistant depression
Quick Inventory of Depressive Symptomatology (QIDS-SR16); 16 items rated from 0 to 3. Total scores range from 0 to 27, with scores of 11 to 15 indicating moderate depression, 16 to 20 reflecting severe depression, and total scores greater than 21 indicating very severe depression.
Measured: Month 1
Effect of a single-dose administration of psilocybin on self-reported treatment-resistant depression
Quick Inventory of Depressive Symptomatology (QIDS-SR16); 16 items rated from 0 to 3. Total scores range from 0 to 27, with scores of 11 to 15 indicating moderate depression, 16 to 20 reflecting severe depression, and total scores greater than 21 indicating very severe depression.
Measured: Month 3
Effect of a single-dose administration of psilocybin on clinician-rated treatment-resistant depression
Inventory of Depressive Symptomatology, clinician-rated (IDS-C-30); 30 items with each symptom rated from 0 to 3.
Measured: Day 0
Effect of a single-dose administration of psilocybin on clinician-rated treatment-resistant depression
Inventory of Depressive Symptomatology, clinician-rated (IDS-C-30); 30 items with each symptom rated from 0 to 3.
Measured: Day 4
Effect of a single-dose administration of psilocybin on clinician-rated treatment-resistant depression
Inventory of Depressive Symptomatology, clinician-rated (IDS-C-30); 30 items with each symptom rated from 0 to 3.
Measured: Month 1
Effect of a single-dose administration of psilocybin on clinician-rated treatment-resistant depression
Inventory of Depressive Symptomatology, clinician-rated (IDS-C-30); 30 items with each symptom rated from 0 to 3.
Measured: Month 3
Effect of a single-dose administration of psilocybin on anhedonia
Behavioral Activation for Depression Scale (BADS); 9 questions, each rated on a seven-point scale ranging from 0 (not at all) to 6 (completely) for a total score 0-36.
Measured: Day 0
Effect of a single-dose administration of psilocybin on anhedonia
Behavioral Activation for Depression Scale (BADS); 9 questions, each rated on a seven-point scale ranging from 0 (not at all) to 6 (completely) for a total score 0-36.
Measured: Day 4
Effect of a single-dose administration of psilocybin on anhedonia
Behavioral Activation for Depression Scale (BADS); 9 questions, each rated on a seven-point scale ranging from 0 (not at all) to 6 (completely) for a total score 0-36.
Measured: Month 1
Effect of a single-dose administration of psilocybin on anhedonia
Behavioral Activation for Depression Scale (BADS); 9 questions, each rated on a seven-point scale ranging from 0 (not at all) to 6 (completely) for a total score 0-36.
Measured: Month 3
Effect of a single-dose administration of psilocybin on behavioral activation scores
Snaith-Hamilton Pleasure Scale (SHAPS); score ranging from 0-14.
Measured: Day 0
Effect of a single-dose administration of psilocybin on behavioral activation scores
Snaith-Hamilton Pleasure Scale (SHAPS); score ranging from 0-14.
Measured: Day 4
Effect of a single-dose administration of psilocybin on behavioral activation scores
Snaith-Hamilton Pleasure Scale (SHAPS); score ranging from 0-14.
Measured: Month 1
Effect of a single-dose administration of psilocybin on behavioral activation scores
Snaith-Hamilton Pleasure Scale (SHAPS); score ranging from 0-14.
Measured: Month 3
Acceptability of a clinical protocol for psilocybin-assisted therapy in France
SATMED-Q; six dimensions for an overall score from 17 items rated from 0 to 4.
Measured: Day 4
Feasibility of a clinical protocol for psilocybin-assisted in France
Adverse events or tolerance problems collected using the PRISE (Patient Rated Inventory of Side Effect) questionnaire
Measured: Day 4
Effect of psilocybin treatment on states of consciousness.
5-Dimensional Altered States of Consciousness Questionnaire; 94 items rated on a visual analog scale, marked as "no, no more than usual" to "yes, much more than usual", with higher values indicating stronger effects.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start19 Nov 2024
- Primary completion26 Mar 2025
- Study completion26 Jun 2025
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 Universitaire de NīmesThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ismaël Conejero, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650800
- Sponsor's protocol ID
- NIMAO/2021-2/JLC-01
- Acronym
- PSILODAC
- Status last verified
- Aug 2025
- First submitted
- 18 Oct 2024
- Last updated
- 20 Aug 2025
- 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 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Psilocybin on the Positive Valence System in Treatment-resistant Depression: a Pilot Clinical Neuroimaging Study
- ClinicalTrials.gov ID
- NCT06650800
- Acronym / sponsor ID
- PSILODAC / NIMAO/2021-2/JLC-01
- Conditions
- Depressive Disorder, Depressive Disorder, Treatment-Resistant, Hallucinogens, Reinforcement, Psychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 26 Mar 2025 (actual)
- Study completion
- 26 Jun 2025 (actual)
- First posted
- 21 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.
The study hypothesis is that the antidepressant effect of psilocybin is mediated by a normalization of the functioning of the positive valence system. Depressive states, especially moderate to severe depressions that associate a certain level of anhedonia, produce an overvaluation of the cost of efforts and an infra-evaluation of the possible rewards derived from an action. Psilocybin would reduce anhedonia and the cost of efforts, facilitating the anticipation of reward. Thus, the antidepressant effect of psilocybin would be mediated by a greater anticipation of rewards (reduction of anhedonia) and a more optimistic estimation of the results of efforts (increase in motivation). Psilocybin-induced changes in the positive valence system will be observable on brain MRI images, particularly in the effort evaluation circuits: basolateral amygdala, dorsal anterior cingulate cortex, ventral pallidum, ventral striatum (VS), ventral tegmental area (VTA). The mesolimbic circuit (VS, VTA) is the anatomical substrate of anticipation of rewarding stimuli (food, sex, drugs). The amygdala also fulfills an associative function between environmental cues and rewarding stimuli. Structural and functional alterations in this circuit are associated with depressive symptoms such as anhedonia or distortions in the perception and memories of rewards. This hypothesis will be tested on a population of patients with moderate or severe depressive symptoms who meet the criteria for TRD.
Detailed description
Depressive disorders are strongly associated with suicide risk and are the leading cause of disability in the world. Psilocybin is a natural alkaloid with psychedelic and hallucinogenic effects, produced by its active metabolite: psilocin. In recent years, there has been a resurgence of research aimed at using psilocybin in the treatment of psychiatric disorders, and in particular depression, combined or not with various psychotherapeutic programs. Psilocybin-assisted therapy is effective in treating cancer-associated depression and resistant depression. The Federal Drug Administration (FDA) has designated it as a "Breakthrough Therapy" in the treatment of treatment-resistant depression (TRD). Most researchers consider that the antidepressant effects of psilocybin are associated with the activation of the serotonin 5-HT2a receptor, with acute neuromodulation effects that modify the connectivity of cortico-striatal loops, but the mechanisms supporting this effect are unknown. The purpose of this study is to verify whether the antidepressant action of psilocybin is associated with an activation of the brain areas involved in the positive valence system, by comparing the activity of the neural circuits responsible for the evaluation of effort before and after taking psilocybin. The correlations between the activation of brain areas and the depression severity, behavioral activation and anhedonia scores will help establish a link with the response to treatment. Finally, the study authors wish to test the feasibility of a study with psilocybin in a French clinical population.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with major depressive episode | Experimental | Drug: Psilocybin, Other: MRI |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- Patient with a current DSM-IV diagnosis of moderate or severe major depressive episode (MDE) without psychotic features (based on clinical assessment and confirmed by the MINI interview and the QIDS).
- Patient who has not responded to at least two antidepressant treatments of different classes, administered appropriately in terms of dose and duration, for a moderate to severe major depressive episode.
- Patients receiving antidepressant treatment of the SSRI (Selective Serotonin Reuptake Inhibitors) or SNRI (Serotonin Norepinephrine Reuptake Inhibitors) classes may maintain this treatment for the duration of the trial, without modification • Patient with a score > 10 on the QIDS scale.
Key exclusion criteria (26 listed)
- The patient is participating in a medical product-based interventional study, or is in a period of exclusion determined by a previous study
- Patient unable to express consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient with allergy, hypersensitivity or other adverse reaction to previous use of psilocybin or other hallucinogens.
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 |
|---|---|---|
| PsilocybinSingle-dose psilocybin administration: oral ingestion of one 25 mg capsule | Drug | Patient with major depressive episode |
| MRI1.5 hour brain MRI before and after psilocybin administration | Other | Patient with major depressive episode |
Primary outcome
Activity of the neural circuits responsible for the evaluation of effort before taking psilocybin
Time frame: Two days before administration of psilocybin
Brain activity measured by fMRI at resting state and during Effort Expenditure for Rewards Task in the basolateral amygdala, dorsal anterior cingulate cortex, ventral pallidum, ventral striatum and ventral tegmental area
Activity of the neural circuits responsible for the evaluation of effort after taking psilocybin
Time frame: Five days after administration of psilocybin
Brain activity measured by fMRI at resting state and during Effort Expenditure for Rewards Task in the basolateral amygdala, dorsal anterior cingulate cortex, ventral pallidum, ventral striatum and ventral tegmental area
19 secondary outcomes
Effect of a single-dose administration of psilocybin on self-reported treatment-resistant depression
Time frame: Day 0
Effect of a single-dose administration of psilocybin on self-reported treatment-resistant depression
Time frame: Day 4
Effect of a single-dose administration of psilocybin on self-reported treatment-resistant depression
Time frame: Month 1
Effect of a single-dose administration of psilocybin on self-reported treatment-resistant depression
Time frame: Month 3
Effect of a single-dose administration of psilocybin on clinician-rated treatment-resistant depression
Time frame: Day 0
Effect of a single-dose administration of psilocybin on clinician-rated treatment-resistant depression
Time frame: Day 4
Effect of a single-dose administration of psilocybin on clinician-rated treatment-resistant depression
Time frame: Month 1
Effect of a single-dose administration of psilocybin on clinician-rated treatment-resistant depression
Time frame: Month 3
Effect of a single-dose administration of psilocybin on anhedonia
Time frame: Day 0
Effect of a single-dose administration of psilocybin on anhedonia
Time frame: Day 4
Effect of a single-dose administration of psilocybin on anhedonia
Time frame: Month 1
Effect of a single-dose administration of psilocybin on anhedonia
Time frame: Month 3
Effect of a single-dose administration of psilocybin on behavioral activation scores
Time frame: Day 0
Effect of a single-dose administration of psilocybin on behavioral activation scores
Time frame: Day 4
Effect of a single-dose administration of psilocybin on behavioral activation scores
Time frame: Month 1
Effect of a single-dose administration of psilocybin on behavioral activation scores
Time frame: Month 3
Acceptability of a clinical protocol for psilocybin-assisted therapy in France
Time frame: Day 4
Feasibility of a clinical protocol for psilocybin-assisted in France
Time frame: Day 4
Effect of psilocybin treatment on states of consciousness.
Time frame: Day 0
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 20 Aug 2025.
Related trials for Depressive Disorder
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
Ismaël Conejero principal investigator
CHU Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psilocybin and MRI in people with Depressive Disorder and Depressive Disorder, Treatment-Resistant, run by Centre Hospitalier Universitaire de Nīmes 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 7 inclusion and 26 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 20 Aug 2025. 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?
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?
Activity of the neural circuits responsible for the evaluation of effort before taking psilocybin (time frame: Two days before administration of psilocybin). The study lists 2 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 20 Aug 2025.