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Psilocybin-assisted CBT for Depression

Phase < 1
Recruiting
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a current major depressive episode or a history of major depressive episodes based on the DSM-5 criteria
Able to swallow capsules
Must not have
Any of the following cardiovascular conditions
Current use of antidepressants or other serotonergic-affecting substances
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7-month study period
Awards & highlights
No Placebo-Only Group

Summary

This trial studies how combining psilocybin (a psychedelic) with therapy helps treat depression. Two doses of psilocybin are given during 12 therapy sessions, and participants are followed for 4 months.

Who is the study for?
This trial is for adults aged 21-60 with depression, who are experiencing a major depressive episode. They must be able to swallow capsules and have someone to drive them home after sessions. Women should use effective contraception. Exclusions include active suicidality, current antidepressant use, certain cardiovascular conditions, insulin-dependent diabetes, history of psychosis or bipolar in the family, prior adverse reaction to psychedelics, pregnancy or nursing.
What is being tested?
The study tests combining psilocybin (a psychedelic drug) with cognitive-behavioral therapy (CBT) for treating major depressive disorder. Participants will receive two oral doses of psilocybin during twelve CBT sessions over four months and then be followed up for three additional months.
What are the potential side effects?
Possible side effects from psilocybin may include nausea, headache, dizziness, increased heart rate and blood pressure changes shortly after taking it. Some might experience emotional distress or confusion during the psychoactive phase.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with major depression now or in the past.
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I can swallow pills.
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I am between 21 and 60 years old.
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I am currently experiencing significant depression symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a heart condition.
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I am currently taking antidepressants or medications that affect serotonin.
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I have epilepsy or a history of seizures.
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I have had a stroke or a transient ischemic attack.
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I use insulin to manage my diabetes.
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I do not have current suicidal thoughts or severe psychiatric issues needing immediate care.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7-month study period
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7-month study period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Global Assessment of Functioning
Hamilton Depression Rating Scale
Treatment acceptability
+1 more

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
9%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Diarrhea
4%
Influenza
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Depression
4%
Insomnia
4%
Suicidal Ideation
4%
Lower resp. tract congestion
4%
Oropharyngeal pain
4%
Alcohol withdrawal syndrome
2%
Migraine
2%
Thrombocytosis
2%
Constipation
2%
Vomiting
2%
Oedema
2%
Peripheral swelling
2%
Pyrexia
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Eye infection
2%
Fungal infection
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Musculoskeletal pain
2%
Pain in extremity
2%
Malignant melanoma
2%
Dizziness
2%
Hypoesthesia
2%
Sedation
2%
Anger
2%
Anxiety
2%
Restlessness
2%
Cough
2%
Rhinorrhea
2%
Sinus congestion
2%
Sexual abuse
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Psilocybin + CBTExperimental Treatment1 Intervention
All participants will receive 12 sessions of cognitive-behavioral therapy (CBT) along with two psilocybin-drug sessions -- the first following the third CBT session (10mg of psilocybin, taken orally) and the second following the sixth CBT session (25mg of psilocybin, taken orally).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
Not yet FDA approved

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,567 Previous Clinical Trials
10,279,461 Total Patients Enrolled
107 Trials studying Depression
49,552 Patients Enrolled for Depression

Media Library

Psilocybin + CBT Clinical Trial Eligibility Overview. Trial Name: NCT05227612 — Phase < 1
Depression Research Study Groups: Psilocybin + CBT
Depression Clinical Trial 2023: Psilocybin + CBT Highlights & Side Effects. Trial Name: NCT05227612 — Phase < 1
Psilocybin + CBT 2023 Treatment Timeline for Medical Study. Trial Name: NCT05227612 — Phase < 1
Depression Patient Testimony for trial: Trial Name: NCT05227612 — Phase < 1
~7 spots leftby Jun 2025