Major Depressive DisorderPhase 2PsiloMDDAUDNCT04620759
Psilocybin Treatment of Major Depressive Disorder With Co-occurring Alcohol Use Disorder
A Phase 2 study testing Psilocybin in people with Major Depressive Disorder and Alcohol Use Disorder, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether psilocybin, a hallucinogenic drug, is effective in reducing depressive symptoms and amount of drinking in patients with co-occurring Major Depressive Disorder (MDD) and Alcohol Use Disorder (AUD). Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Major Depressive Disorder, Alcohol Use Disorder
- What is being tested?
- Psilocybin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2021to 30 Mar 2027
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 to 65 years old
- Fluent in English
- Have given written informed consent
- Have at least a high-school level of education or equivalent (e.g. GED).
- Have a baseline GRID-HAMD score ≥ 16
- Have a confirmed DSM-5 diagnosis of Major Depressive Disorder and currently experiencing a major depressive episode
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- Have a confirmed DSM-5 diagnosis of Alcohol Use Disorder
- Have undergone some form of therapy for MDD or AUD in the past, but are not interested in initiating standard pharmacotherapies for major depressive disorder or alcohol use disorder (e.g. selective serotonin reuptake inhibitor, disulfiram, naloxone, etc.)
- Be judged by study team clinicians to be at low risk for suicidality
- Average of at least 4 non-drinking day/month in the past 90 days, or a score of less than 4 on the PAWWS scale
- Have at least 2 heavy drinking days per month in the past 90 days
- Concurrent psychotherapy or pharmacotherapy with SSRIs, SNRIs, and/or bupropion is allowed if the type and frequency of the therapy has been stable for at least two months prior to screening and is expected to remain stable during participation in the study
- Be medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests
- Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of drug session days. If the participant does not routinely consume caffeinated beverages, he/she must agree not to do so on session days
- Agree to refrain from using any psychoactive drugs, including nicotine, within 24 hours of each drug administration. The exception is caffeine
- Agree not to take any "as needed" medications on the mornings of drug sessions
- Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration
- Agree to use effective methods of contraception during the study (females)
- Agree that for one week before each drug session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals
- Have limited lifetime use of hallucinogens (the following criteria are preferred: no use in the past 5 years; total hallucinogen use less than 10 times)
- Proof of COVID-19 vaccination
Who cannot join
- Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of child-bearing potential and sexually active who are not practicing an effective means of contraception.
- Blood liver tests assessed at screening that are outside of 3x the normal range
- Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g., atrial fibrilation), prolonged corrected QT (QTc) interval (i.e., QTc > 450 msec), artificial heart valve, or transient ischemic attack in the past year
- Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar) score > 9, or any other indication that the volunteer may experience medically complicated withdrawal from alcohol
- Any history of seizures, including alcohol withdrawal seizures
- Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
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- Currently taking psychoactive prescription medication on a regular (e.g., daily) basis
- Currently taking on a regular (e.g., daily) basis any antidepressant medications other than SSRIs, SNRIs, or bupropion, or any other medications that have a primary centrally-acting serotonergic effect, including mono-amine oxidase inhibitors (MAOIs). For individuals who have intermittent or "as-needed" use of such medications, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose.
- Currently taking more than 300mg bupropion daily
- Currently taking medications for the treatment of depression or alcohol use disorder
- Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I or II Disorder
- Current or history within one year of meeting DSM-5 criteria for a moderate or severe substance use disorder (excluding caffeine, nicotine, and alcohol)
- If a smoker or nicotine user, consuming the equivalent of more than 10 cigarettes per day.
- Have a first or second-degree relative with schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition)
- Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin
- History of a medically significant suicide attempt (e.g. an attempt characterized by strong intent and/or high lethality)
- Has failed to respond to electroconvulsive therapy during the current major depressive episode
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Center for Psychedelic and Consciousness Research
Baltimore, Maryland, 21224
About this study
The purpose of this study is to determine whether psilocybin, a hallucinogenic drug, is effective in reducing depressive symptoms and amount of drinking in patients with co-occurring Major Depressive Disorder (MDD) and Alcohol Use Disorder (AUD).
Read the detailed description
The objectives of this double-blind, placebo-controlled study are to test the hypotheses that a single high (25 mg) oral dose of psilocybin will lead to enduring reductions in depressive symptoms (as measured by the clinician-rated grid version of the Hamilton Depression Rating Scale, or GRID-HAMD) and amount of drinking (as measured using the Time Line Follow Back, or TLFB, procedure) compared to placebo in patients with co-occurring MDD and AUD. 90 male and female volunteers who are between the ages of 21 and 65 years old and who meet Diagnostic and Statistical Manual, Fifth Edition (DSM-5) criteria for MDD and AUD will be recruited from the community and complete all study procedures. Volunteers will be randomized to one of two study arms (psilocybin [N=45] or placebo [N=45]), and will complete a drug administration session paired with a brief Motivational Interviewing intervention for alcohol use. Volunteers will undergo assessments of depression and alcohol use before and after treatment. After primary endpoints are measured, all volunteers will receive a second, unblinded intervention with a single high dose of psilocybin (25 mg) to test a secondary hypothesis that two doses of psilocybin are more effective in treating MDD with co-occurring AUD than a single dose.
- Conditions
- Major Depressive Disorder, Alcohol Use Disorder
- Being tested
- Psilocybin, Placebo
- Medical subject headings
- Depressive Disorder, Major, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Also called 4-phosphoryloxy-N,N-dimethyltryptamine
The psilocybin used in this study is synthetically manufactured and formulated under current good manufacturing practices (cGMP). The active drug is encapsulated using a size 0 blue gelatin capsule and contains 25 mg of psilocybin.
PlaceboDrug
The placebo used in this study is microcrystalline cellulose, an inert substance, encapsulated using a size 0 blue gelatin capsule.
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin Treatment | Experimental | Participants will be administered 25mg of psilocybin in a clinical setting. Psilocybin is administered orally as a capsule and taken with water. Receives: Drug: Psilocybin |
| Placebo | Placebo comparator | Participants will be administered placebo in a clinical setting. Placebo is administered orally as a capsule taken with water. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in grid-version of the Hamilton Depression Rating Scale (GRID-HAMD) score
The GRID-Hamilton Depression Rating Scale is a 17-item clinician-administered rating scale designed to assess severity of depressive symptoms. The score range for the GRID-HAMD is 0 to 52, with higher score indicating more severe depression.
Measured: Baseline and 1 month after first experimental drug administration session
Change from baseline in percentage of days abstinent as measured by the Time Line Follow Back (TLFB) assessment
The TLFB is a widely used, standardized, calendar-based retrospective self-report assessment to quantify daily alcohol use. The investigators will examine the primary outcome of percentage of abstinent days in the past 90 days.
Measured: Baseline and 3 months after first experimental drug administration session
Change from baseline in percentage of days of heavy drinking as measured by the TLFB assessment
The TLFB is a widely used, standardized, calendar-based retrospective self-report assessment to quantify daily alcohol use. The investigators will examine the primary outcome of percentage of drinking days in the past 90 days.
Measured: Baseline and 3 months after first experimental drug administration session
Change from baseline in gamma-glutamyl transferase (GGT)
Change in GGT (IU/L) will be measured by peripheral blood tests. GGT is elevated in chronic drinkers. Elevated GGT due to drinking can begin to reduce after a week of abstinence, and can return to normal levels after roughly 4 weeks of abstinence.
Measured: Baseline and 3 months after first experimental drug administration session
Change from baseline in the percentage of carbohydrate deficient transferrin relative to total transferrin concentration (%CDT)
Change in %CDT will be measured by peripheral blood tests. %CDT can become elevated after 1 to 2 weeks of heavy drinking, and can return to normal levels within 2 weeks of abstinence.
Measured: Baseline and 3 months after first experimental drug administration session
Change from baseline in the ratio of aspartate transaminase to alanine transaminase (AST/ALT)
Change in AST/ALT ratio will be measured by peripheral blood tests. Elevated AST/ALT ratio has been associated with heavy drinking, and can return to normal levels after extended abstinence.
Measured: Baseline and 3 months after first experimental drug administration session
Secondary outcomes (7)
Change from baseline in Quick Inventory of Depressive Symptomatology - Self Rated (QIDS-SR) score
The Quick Inventory of Depressive Symptomatology is a 16-item self-report questionnaire that measures the nine symptom domains of a depressive episode, with higher scores indicating greater depression severity. This questionnaire is rated on a scale of 0 to 3. These values represent varying answers for each item and can be found within the questionnaire.
Measured: Baseline, 1 week, 1 month, and 3 month post-drug-session visits; 6 and 12 month follow-ups after the second experimental drug administration session.
Change from baseline in State Trait Anxiety Index (STAI) score
The STAI is a 40-item self-report measure that assessing anxiety on two different scales: State and Trait. State anxiety is scored on a 4-point scale (1 = Not at all; 2 = Somewhat; 3 = Moderately so; 4 = Very much so) and Trait anxiety is scored on the 4-point scale (1 = Almost never; 2 = Sometimes; 3 = Often; 4 = Almost always).
Measured: Baseline, 1 week, 1 month, and 3 month post-drug-session visits; 6 and 12 month follow-ups after the second experimental drug administration session
Change from baseline in percentage of days abstinent as measured by the TLFB assessment
The TLFB is a widely used, standardized, calendar-based retrospective self-report assessment to quantify daily alcohol use. The investigators will examine the secondary outcome of percentage of abstinent days either within the last 30 days or the last 90 days, depending on study visit.
Measured: Baseline, 1 month post drug administration session, 3 months after the second (unblinded) drug administration session, and at 6 and 12 months post second (unblinded) drug administration session
Change from baseline in percentage of days of heavy drinking as measured by the TLFB assessment
The TLFB is a widely used, standardized, calendar-based retrospective self-report assessment to quantify daily alcohol use. The investigators will examine the secondary outcome of percentage of drinking days either within the last 30 days or the last 90 days, depending on study visit.
Measured: Baseline, 1 month post drug administration session, 3 months after the second (unblinded) drug administration session, and at 6 and 12 months post second (unblinded) drug administration session
Change from baseline in GGT
Change in GGT (IU/L) will be measured by peripheral blood tests. GGT is elevated in chronic drinkers. Elevated GGT due to drinking can begin to reduce after a week of abstinence, and can return to normal levels after roughly 4 weeks of abstinence.
Measured: Baseline, 1 month post drug administration session, 3 months after the second (unblinded) drug administration session
Change from baseline in %CDT
Change in %CDT will be measured by peripheral blood tests. %CDT can become elevated after 1 to 2 weeks of heavy drinking, and can return to normal levels within 2 weeks of abstinence.
Measured: Baseline, 1 month post drug administration session, 3 months after the second (unblinded) drug administration session
Change from baseline in AST/ALT ratio
Change in AST/ALT ratio will be measured by peripheral blood tests. Elevated AST/ALT ratio has been associated with heavy drinking, and can return to normal levels after extended abstinence.
Measured: Baseline, 1 month post drug administration session, 3 months after the second (unblinded) drug administration session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start14 Apr 2021
- Primary completion2 Mar 2026
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Usona Institute
- Responsible party
- Sponsor
- Investigators
- Frederick S Barrett, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620759
- Sponsor's protocol ID
- IRB00233684
- Acronym
- PsiloMDDAUD
- Status last verified
- Mar 2026
- First submitted
- 3 Nov 2020
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psilocybin Treatment of Major Depressive Disorder With Co-occurring Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT04620759
- Acronym / sponsor ID
- PsiloMDDAUD / IRB00233684
- Conditions
- Major Depressive Disorder, Alcohol Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Usona Institute
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 9 Nov 2020 (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 purpose of this study is to determine whether psilocybin, a hallucinogenic drug, is effective in reducing depressive symptoms and amount of drinking in patients with co-occurring Major Depressive Disorder (MDD) and Alcohol Use Disorder (AUD).
Detailed description
The objectives of this double-blind, placebo-controlled study are to test the hypotheses that a single high (25 mg) oral dose of psilocybin will lead to enduring reductions in depressive symptoms (as measured by the clinician-rated grid version of the Hamilton Depression Rating Scale, or GRID-HAMD) and amount of drinking (as measured using the Time Line Follow Back, or TLFB, procedure) compared to placebo in patients with co-occurring MDD and AUD. 90 male and female volunteers who are between the ages of 21 and 65 years old and who meet Diagnostic and Statistical Manual, Fifth Edition (DSM-5) criteria for MDD and AUD will be recruited from the community and complete all study procedures. Volunteers will be randomized to one of two study arms (psilocybin [N=45] or placebo [N=45]), and will complete a drug administration session paired with a brief Motivational Interviewing intervention for alcohol use. Volunteers will undergo assessments of depression and alcohol use before and after treatment. After primary endpoints are measured, all volunteers will receive a second, unblinded intervention with a single high dose of psilocybin (25 mg) to test a secondary hypothesis that two doses of psilocybin are more effective in treating MDD with co-occurring AUD than a single dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psilocybin Treatment | Experimental | Drug: PsilocybinParticipants will be administered 25mg of psilocybin in a clinical setting. Psilocybin is administered orally as a capsule and taken with water. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will be administered placebo in a clinical setting. Placebo is administered orally as a capsule taken with water. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 21 to 65 years old
- Fluent in English
- Have given written informed consent
- Have at least a high-school level of education or equivalent (e.g. GED).
- Have a baseline GRID-HAMD score ≥ 16
Key exclusion criteria (17 listed)
- Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of child-bearing potential and sexually active who are not practicing an effective means of contraception.
- Blood liver tests assessed at screening that are outside of 3x the normal range
- Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g., atrial fibrilation), prolonged corrected QT (QTc) interval (i.e., QTc > 450 msec), artificial heart valve, or transient ischemic attack in the past year
- Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar) score > 9, or any other indication that the volunteer may experience medically complicated withdrawal from alcohol
- Any history of seizures, including alcohol withdrawal seizures
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 |
|---|---|---|
| PsilocybinAlso: 4-phosphoryloxy-N,N-dimethyltryptamineThe psilocybin used in this study is synthetically manufactured and formulated under current good manufacturing practices (cGMP). The active drug is encapsulated using a size 0 blue gelatin capsule and contains 25 mg of psilocybin. | Drug | Psilocybin Treatment |
| PlaceboThe placebo used in this study is microcrystalline cellulose, an inert substance, encapsulated using a size 0 blue gelatin capsule. | Drug | Placebo |
Primary outcome
Change from baseline in grid-version of the Hamilton Depression Rating Scale (GRID-HAMD) score
Time frame: Baseline and 1 month after first experimental drug administration session
The GRID-Hamilton Depression Rating Scale is a 17-item clinician-administered rating scale designed to assess severity of depressive symptoms. The score range for the GRID-HAMD is 0 to 52, with higher score indicating more severe depression.
Change from baseline in percentage of days abstinent as measured by the Time Line Follow Back (TLFB) assessment
Time frame: Baseline and 3 months after first experimental drug administration session
The TLFB is a widely used, standardized, calendar-based retrospective self-report assessment to quantify daily alcohol use. The investigators will examine the primary outcome of percentage of abstinent days in the past 90 days.
Change from baseline in percentage of days of heavy drinking as measured by the TLFB assessment
Time frame: Baseline and 3 months after first experimental drug administration session
The TLFB is a widely used, standardized, calendar-based retrospective self-report assessment to quantify daily alcohol use. The investigators will examine the primary outcome of percentage of drinking days in the past 90 days.
Change from baseline in gamma-glutamyl transferase (GGT)
Time frame: Baseline and 3 months after first experimental drug administration session
Change in GGT (IU/L) will be measured by peripheral blood tests. GGT is elevated in chronic drinkers. Elevated GGT due to drinking can begin to reduce after a week of abstinence, and can return to normal levels after roughly 4 weeks of abstinence.
Change from baseline in the percentage of carbohydrate deficient transferrin relative to total transferrin concentration (%CDT)
Time frame: Baseline and 3 months after first experimental drug administration session
Change in %CDT will be measured by peripheral blood tests. %CDT can become elevated after 1 to 2 weeks of heavy drinking, and can return to normal levels within 2 weeks of abstinence.
Change from baseline in the ratio of aspartate transaminase to alanine transaminase (AST/ALT)
Time frame: Baseline and 3 months after first experimental drug administration session
Change in AST/ALT ratio will be measured by peripheral blood tests. Elevated AST/ALT ratio has been associated with heavy drinking, and can return to normal levels after extended abstinence.
7 secondary outcomes
Change from baseline in Quick Inventory of Depressive Symptomatology - Self Rated (QIDS-SR) score
Time frame: Baseline, 1 week, 1 month, and 3 month post-drug-session visits; 6 and 12 month follow-ups after the second experimental drug administration session.
Change from baseline in State Trait Anxiety Index (STAI) score
Time frame: Baseline, 1 week, 1 month, and 3 month post-drug-session visits; 6 and 12 month follow-ups after the second experimental drug administration session
Change from baseline in percentage of days abstinent as measured by the TLFB assessment
Time frame: Baseline, 1 month post drug administration session, 3 months after the second (unblinded) drug administration session, and at 6 and 12 months post second (unblinded) drug administration session
Change from baseline in percentage of days of heavy drinking as measured by the TLFB assessment
Time frame: Baseline, 1 month post drug administration session, 3 months after the second (unblinded) drug administration session, and at 6 and 12 months post second (unblinded) drug administration session
Change from baseline in GGT
Time frame: Baseline, 1 month post drug administration session, 3 months after the second (unblinded) drug administration session
Change from baseline in %CDT
Time frame: Baseline, 1 month post drug administration session, 3 months after the second (unblinded) drug administration session
Change from baseline in AST/ALT ratio
Time frame: Baseline, 1 month post drug administration session, 3 months after the second (unblinded) drug administration session
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 13 Mar 2026.
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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.
Frederick S Barrett, PhD principal investigator
Johns Hopkins University
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 in people with Major Depressive Disorder and Alcohol Use Disorder, run by Johns Hopkins University at 1 site in United States.
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 21 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 13 Mar 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 United States. 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?
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?
Change from baseline in grid-version of the Hamilton Depression Rating Scale (GRID-HAMD) score (time frame: Baseline and 1 month after first experimental drug administration session). The study lists 6 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 13 Mar 2026.