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Psychedelic

Psilocybin for Depression and Personality Disorders

Phase 2

Recruiting

Led By Jon E Grant, MD, JD, MPH

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with current major depressive disorder

Age 18-65

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 2 to week 5

Awards & highlights

Study Summary

This trial will test whether psilocybin is a safe and effective treatment for major depressive disorder and borderline personality disorder.

Who is the study for?

This trial is for adults aged 18-65 with both major depressive disorder and borderline personality disorder, as indicated by specific scores on the MADRS and ZAN-BPD scales. Participants must understand and sign a consent form. Those with bipolar I, schizophrenia, active substance use disorders (except cannabis), or unstable medical conditions cannot join.Check my eligibility

What is being tested?

The study aims to test the safety and effectiveness of psilocybin—a psychedelic compound—in treating individuals who have both major depressive disorder (MDD) and borderline personality disorder (BPD).See study design

What are the potential side effects?

While not explicitly listed in the provided information, common side effects of psilocybin may include nausea, headache, increased heart rate, changes in sensory perception, mood alteration, anxiety or panic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with major depression.

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I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 2 to week 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 2 to week 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2 to week 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Borderline Personality Disorder Symptom Assessment Scale (BPD-SAS)

Montgomery-Asberg Depression Rating Scale (MADRS)

Secondary outcome measures

Clinical Global Impression - Improvement scale (CGI-I)

Clinical Global Impression - Severity scale (CGI-S)

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

Fungal infection

Rhinorrhea

Pyrexia

Hypoesthesia

Oedema

Vomiting

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: Experimental: PsilocybinExperimental Treatment1 Intervention

Single 25 mg capsule oral dose of psilocybin

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psilocybin

Not yet FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,004 Previous Clinical Trials

819,767 Total Patients Enrolled

18 Trials studying Depression

11,249 Patients Enrolled for Depression

Usona InstituteOTHER

12 Previous Clinical Trials

748 Total Patients Enrolled

7 Trials studying Depression

592 Patients Enrolled for Depression

Jon E Grant, MD, JD, MPHPrincipal InvestigatorUniversity of Chicago

9 Previous Clinical Trials

471 Total Patients Enrolled

Media Library

Psilocybin (Psychedelic) Clinical Trial Eligibility Overview. Trial Name: NCT05399498 — Phase 2

Depression Research Study Groups: Experimental: Psilocybin

Depression Clinical Trial 2023: Psilocybin Highlights & Side Effects. Trial Name: NCT05399498 — Phase 2

Psilocybin (Psychedelic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05399498 — Phase 2

Depression Patient Testimony for trial: Trial Name: NCT05399498 — Phase 2

Frequently Asked Questions

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

Are people of majority age being allowed to participate in this research?

"Eligibility requirements for this study include being over 18 and younger than 65."

Answered by AI

Has Psilocybin been certified by the FDA?

"While there is some data supporting its safety, psilocybin only received a 2 because there are no studies yet that confirm its efficacy."

Answered by AI

How can I sign up to participate in this research?

"The aim of this clinical trial is to find 10 participants, all adults between 18-65 years old, who have been diagnosed with both borderline personality disorder and major depressive disorder. Additionally, these patients must have a Montgomery-Asberg Depression Rating Scale (MADRS) score greater than 20 and a Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) score that exceeds 9. Lastly, all potential candidates for the study must be able to understand and sign the required consent form."

Answered by AI

Are patients currently being enrolled in this experiment?

"This particular trial, which was last edited on August 4th, is not recruiting patients at the moment. However, there are 2149 other medical studies that are still looking for participants."

Answered by AI