Psilocybin + CBT for Depression

UCLA Semel Institute, Los Angeles, CA
PsilocybinPhase < 1Waitlist AvailableResearch Sponsored by University of California, Los Angeles

Study 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.

Eligible Conditions
  • Depression

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You are currently experiencing a severe episode of depression or have a history of severe depression according to a specific set of guidelines.

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

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

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
44%
Headache
21%
Nausea
15%
Anxiety
8%
Suicidal Ideation
6%
Depressed mood
6%
Insomnia
4%
Abdominal pain upper
4%
Vomiting
4%
Corona virus infection
4%
Upper respiratory tract infection
4%
Viral upper resp. tract infection
4%
Alcohol poisoning
4%
Depression
4%
Pneumonia
2%
Palpitations
2%
Cataract
2%
Abdominal pain
2%
Toothache
2%
Pain
2%
Limb injury
2%
Muscle strain
2%
Biopsy cervix
2%
Blood pressure diastolic increased
2%
Blood pressure increased
2%
Back pain
2%
Musculoskeletal pain
2%
Myalgia
2%
Dizziness
2%
Psychomotor hyperactivity
2%
Alcohol withdrawal syndrome
2%
Dysphoria
2%
Illusion
2%
Urinary incontinence
2%
Testicular pain
2%
Hyperventilation
2%
Food poisoning
2%
Food allergy
2%
Dyspepsia
2%
Influenza
2%
Nasal congestion
2%
Skin cosmetic procedure
2%
Photopsia
2%
Diverticulitis
2%
Asthenia
2%
Fatigue
2%
Gingivitis
2%
Dyspnea
2%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Psilocybin
Diphenhydramine

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
2021
Completed Phase 2
~680

Find a site

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,467 Previous Clinical Trials
10,148,906 Total Patients Enrolled
99 Trials studying Depression
40,049 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

May seniors aged 70 or younger join this experiment?

"Per the study's specifications, participants must be between 21 and 60 years old. Separately, there are 121 trials targeting minors and 630 for elderly patients."

Answered by AI

Is it currently feasible to enroll in this research project?

"According to clinicaltrials.gov, this medical research project is no longer actively searching for volunteers; it was initially posted on June 27th 2023 and last modified on July 11th 2023. However, 876 other trials are still open for recruitment at present."

Answered by AI

Is participation in this research endeavor open to me?

"This clinical trial is enrolling 30 adults between the ages of 21 and 60 who have been diagnosed with depression. In addition to meeting this requirement, applicants must be able to swallow capsules, present current major depressive episodes or a history thereof based on DSM-5 guidelines (American Psychiatric Association 2013), display active symptoms as measured by Hamilton-Depression Rating Scale scores higher than 16 over the last two weeks(Hamilton 1986), identify an individual that can pick them up from UCLA Semel Institute following psilocybin sessions, use one form of highly effective contraception such as oral contraceptive pills if applicable and commit to continuing its use for the duration of their"

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
What site did they apply to?
UCLA Semel Institute
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I am finally at a point in my life where the suffering is over and it’s time for me to heal. Except everything that is suppose to help me is hurting me more. I feel I’ve fell into the system and I’m stuck. I’m begging for help and there is nothing out there for me. This is my last resort.
Patient
~20 spots leftby Jun 2025