Psilocybin + CBT for Depression

Q: 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.

Q: 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.

Q: 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 <a href="https://www.withpower.com/clinical-trials/depression">depression</a>. 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 <a href="https://www.withpower.com/clinical-trials/psilocybin">psilocybin</a> sessions, use one form of highly effective cont<a href="https://www.withpower.com/clinical-trials/ra">ra</a>ception such as oral contraceptive pills if applicable and commit to continuing its use for the duration of their

UCLA Semel Institute, Los Angeles, CA

PsilocybinPhase < 1Waitlist AvailableResearch 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 (American Psychiatric Association, 2013)

Be between 18 and 65 years old

Must not have

Be younger than 18 years old

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up7-month study period

Awards & highlights

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7-month study period

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

Suicidal Ideation

Depressed mood

Insomnia

Abdominal pain upper

Vomiting

Corona virus infection

Upper respiratory tract infection

Viral upper resp. tract infection

Alcohol poisoning

Depression

Pneumonia

Palpitations

Cataract

Abdominal pain

Toothache

Pain

Limb injury

Muscle strain

Biopsy cervix

Blood pressure diastolic increased

Blood pressure increased

Back pain

Musculoskeletal pain

Myalgia

Dizziness

Psychomotor hyperactivity

Alcohol withdrawal syndrome

Dysphoria

Illusion

Urinary incontinence

Testicular pain

Hyperventilation

Food poisoning

Food allergy

Dyspepsia

Influenza

Nasal congestion

Skin cosmetic procedure

Photopsia

Diverticulitis

Asthenia

Fatigue

Gingivitis

Dyspnea

Oropharyngeal pain

100%

80%

60%

40%

20%

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

0 / 1Eligibility criteria met

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?

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

Recent research and studies

clinicaltrials.govStudy

Psilocybin-assisted CBT for Depression

Marc J. Weintraub, PhD 2023. "Psilocybin-assisted CBT for Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05227612.