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Psilocybin-assisted 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 contraception such as oral contraceptive pills if applicable and commit to continuing its use for the duration of their

Phase < 1

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7-month study period

Awards & highlights

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.

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.Check my eligibility

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.See study design

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.

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

Nausea

Pain

Viral upper resp. tract infection

Back pain

Bronchitis

Suicidal Ideation

Oropharyngeal pain

Insomnia

Influenza

Depression

Diarrhea

Headache

Sinus headache

Depressed mood

Lower resp. tract congestion

Alcohol withdrawal syndrome

Restlessness

Pyrexia

Hypoesthesia

Oedema

Fungal infection

Vomiting

Rhinorrhea

Musculoskeletal pain

Peripheral swelling

Thrombocytosis

Eye infection

Constipation

Dermatitis contact

Bronchitis bacterial

Traumatic lung injury

Hyponatremia

Arthralgia

Pain in extremity

Dizziness

Migraine

Sedation

Anger

Anxiety

Cough

Sexual abuse

Sinus congestion

Malignant melanoma

Endodontic procedure

Mallory-Weiss Syndrom

Anemia

Influenza like Illness

Gingivitis

Arthoscopic surgery

100%

80%

60%

40%

20%

Study treatment Arm

Diphenhydramine

Psilocybin

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,528 Previous Clinical Trials

10,276,821 Total Patients Enrolled

102 Trials studying Depression

48,443 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?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I have tried numerous drugs without success. My depression has a significant impact on my life and I would like it to be better.

PatientReceived 1 prior treatment

I have tried 3 different drugs for the last 3 years for depression, anxiety and insomnia: nothing worked. I searched for alternative healing methods and come across mushroom therapy for veterans with depression and ptsd . I hope it may help me. Thank you for giving me chance.

PatientReceived 1 prior treatment

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.

PatientReceived 2+ prior treatments

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.

All > Psilocybin