Depression - Major Depressive DisorderPhase 2NCT07566104
Group PACBT for Depression
A Phase 2 study testing Psilocybin (drug) and Group Cognitive Behavioral Therapy in people with Depression - Major Depressive Disorder and Psilocybin, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study will seek to determine the (1) acceptability and (2) feasibility of psilocybin as an adjunct to cognitive-behavioral therapy, delivered as a group treatment (G-PACBT) for major depressive disorder and (3) explore the clinical effects of G-PACBT on depressive symptoms and psychosocial functioning. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Depression - Major Depressive Disorder, Psilocybin, Cognitive Behavioral Therapy
- What is being tested?
- Psilocybin (drug) and Group Cognitive Behavioral Therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Dec 2028
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ages 21-60,
- Fluent in English
- Able to swallow capsules,
- Meets for a current major depressive episode or a history of major depressive episodes based on the DSM-5 criteria (American Psychiatric Association, 2013),
- Active current depressive symptoms (i.e., scores >16 on the Hamilton-Depression Rating Scale covering the prior 2 weeks; Hamilton, 1986),
- Have an identified support person (i.e., trusted adult friend or relative) who can pick up the individual from UCLA Semel Institute and drive individual home following psilocybin sessions,
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- For women of child-bearing potential - using one form of highly effective contraception (e.g., oral contraceptive pill) and willingness to continue contraceptive use for duration of study. Must be willing to take on-site pregnancy tests.
- Agree to refrain from any psychoactive drug (including alcohol) within 24 hours of each drug session and during the drug sessions. Participants will be allowed to consume their usual amount of caffeine prior to and after the drug sessions.
- Agree to not take any PRN medications on the mornings of the drug sessions
- Has been medically cleared for the study by a physician
- Participants must remain on anti-hypertensive medications if prescribed previously to manage hypertension
Who cannot join
- A personal or family history (first-degree) of psychosis or mania
- Resting blood pressure above 140 systolic, 90 diastolic or heart rate > 90 beats per minute (averaged across four separate measurements)
- Meeting criteria for a DSM-5 cluster B personality disorder (narcissistic, histrionic, borderline, antisocial personality disorder),
- Active suicidality (i.e., HAM-D item 3 score of greater than 3) or other psychiatric disturbance requiring acute treatment
- Current use of antidepressants or other serotonergic-affecting substances (e.g., St. John's Wort and 5-hydroxytryptophan), lithium, or efavirenz [regardless of whether the drug(s) is/are prescribed for MDD or other conditions]
- Current use of opioids (e.g., codeine, fentanyl, hydrocodone, meperidine, tramadol)
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- Currently receiving cognitive behavioral therapy,
- Any of the following cardiovascular conditions: uncontrolled hypertension, coronary artery disease, congenital long QT syndrome, cardiac hypertrophy, cardiac ischemia, congestive heart failure, myocardial infarction, tachycardia, artificial heart valve, a clinically significant screening ECG abnormality, or any other significant cardiovascular condition
- QTc interval measurement of > 450 ms in males or > 460 ms in females as measured by the baseline ECG
- A history of stroke or Transient Ischemic Attack (TIA)
- Epilepsy or history of seizures
- Insulin-dependent diabetes
- Meeting criteria for a DSM-5 substance abuse or dependence within prior 6 months (including for nicotine and cannabis)
- Positive urine drug screen for illicit substances (not including cannabis)
- Use of other psychedelics or ketamine within prior 12 months
- Adverse prior reaction to a 5-HT2A receptor agonist psychedelic agent
- Pregnant, trying to get pregnant, or nursing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UCLA Semel Institute
Los Angeles, California, 90095
Shelby Grody, 3108254354, UCLAPAT@mednet.ucla.edu
Marc Weintraub, PhD
About this study
Official title: Group Psilocybin-assisted Cognitive Behavioral Therapy for Major Depressive Disorder
This study will seek to determine the (1) acceptability and (2) feasibility of psilocybin as an adjunct to cognitive-behavioral therapy, delivered as a group treatment (G-PACBT) for major depressive disorder and (3) explore the clinical effects of G-PACBT on depressive symptoms and psychosocial functioning.
- Being tested
- Psilocybin (drug), Group Cognitive Behavioral Therapy
- Keywords
- group treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin (drug)Drug
Two administrations of psilocybin, administered orally (a 10mg dose followed by a 25mg dose one month later)
Group Cognitive Behavioral TherapyBehavioural
12 sessions of PA-CBT (as manualized by our research team; Weintraub et al., 2023)
| Study group | Role | What they receive |
|---|---|---|
| Group PACBT | Experimental | 12 sessions of PA-CBT (as manualized by our research team; Weintraub et al., 2023) and two administrations of psilocybin, administered orally (a 10mg dose followed by a 25mg dose one month later), all of which will be delivered in a group format whereby participants receive the treatments together and simultaneously Receives: Drug: Psilocybin (drug); Behavioral: Group Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment acceptability
Treatment acceptability as measured by the participant on the Client Satisfaction Questionnaire-8. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Measured: 4 months (Baseline to Post-treatment)
Feasibility as measured by participant retention
Participant retention over the treatment
Measured: 4 months
Hamilton Depression Rating Scale
Depressive symptom severity scored from 0-53, with larger values indicating greater depressive severity
Measured: 7 months (Baseline to end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (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 University of California, Los AngelesThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc J. Weintraub, PhD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566104
- Sponsor's protocol ID
- 25-0602
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Psilocybin-assisted Cognitive Behavioral Therapy for Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT07566104
- Acronym / sponsor ID
- 25-0602
- Keywords
- group treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 4 May 2026 (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.
This study will seek to determine the (1) acceptability and (2) feasibility of psilocybin as an adjunct to cognitive-behavioral therapy, delivered as a group treatment (G-PACBT) for major depressive disorder and (3) explore the clinical effects of G-PACBT on depressive symptoms and psychosocial functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group PACBT | Experimental | Drug: Psilocybin (drug), Behavioral: Group Cognitive Behavioral Therapy12 sessions of PA-CBT (as manualized by our research team; Weintraub et al., 2023) and two administrations of psilocybin, administered orally (a 10mg dose followed by a 25mg dose one month later), all of which will be delivered in a group format whereby participants receive the treatments together and simultaneously |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Ages 21-60,
- Fluent in English
- Able to swallow capsules,
- Meets for a current major depressive episode or a history of major depressive episodes based on the DSM-5 criteria (American Psychiatric Association, 2013),
- Active current depressive symptoms (i.e., scores >16 on the Hamilton-Depression Rating Scale covering the prior 2 weeks; Hamilton, 1986),
Key exclusion criteria (17 listed)
- A personal or family history (first-degree) of psychosis or mania
- Resting blood pressure above 140 systolic, 90 diastolic or heart rate > 90 beats per minute (averaged across four separate measurements)
- Meeting criteria for a DSM-5 cluster B personality disorder (narcissistic, histrionic, borderline, antisocial personality disorder),
- Active suicidality (i.e., HAM-D item 3 score of greater than 3) or other psychiatric disturbance requiring acute treatment
- Current use of antidepressants or other serotonergic-affecting substances (e.g., St. John's Wort and 5-hydroxytryptophan), lithium, or efavirenz [regardless of whether the drug(s) is/are prescribed for MDD or other conditions]
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 (drug)Two administrations of psilocybin, administered orally (a 10mg dose followed by a 25mg dose one month later) | Drug | Group PACBT |
| Group Cognitive Behavioral Therapy12 sessions of PA-CBT (as manualized by our research team; Weintraub et al., 2023) | Behavioural | Group PACBT |
Primary outcome
Treatment acceptability
Time frame: 4 months (Baseline to Post-treatment)
Treatment acceptability as measured by the participant on the Client Satisfaction Questionnaire-8. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Feasibility as measured by participant retention
Time frame: 4 months
Participant retention over the treatment
Hamilton Depression Rating Scale
Time frame: 7 months (Baseline to end of study)
Depressive symptom severity scored from 0-53, with larger values indicating greater depressive severity
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 4 May 2026.
- Individual participant dataSharing planned: No
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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.
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 (drug) and Group Cognitive Behavioral Therapy in people with Depression - Major Depressive Disorder and Psilocybin, run by University of California, Los Angeles 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 11 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: opening soon, as of the sponsor's last update on 4 May 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment acceptability (time frame: 4 months (Baseline to Post-treatment)). The study lists 3 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 4 May 2026.