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Psychedelic

Psilocybin for Major Depressive Disorder

Q: Has the Food and Drug Administration officially sanctioned the use of psilocybin?

<p><a href="https://www.withpower.com/clinical-trials/psilocybin">Psilocybin</a>'s safety is rated as 2 on a scale of 1 to 3 by our team at Power for this Phase 2 trial, indicating that there is limited data supporting its safety but none supporting efficacy.</p>

Phase 2

Waitlist Available

Led By Andrew M Novick, MD, PhD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

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

Must have

Adults ≥ 21 years of age at Baseline Visit 1

The participant's Major depressive disorder meets the criteria for being treatment-resistant, defined as not experiencing a 50% improvement to two or more antidepressant treatments for adequate duration (6 weeks minimum) within the current episode, as determined by the Antidepressant Treatment Response Questionnaire (Desseilles et al., 2011; Posternak et al., 2004)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up eight weeks post-dosing

Awards & highlights

Study Summary

This trial aims to assess how effective psilocybin is in treating the lack of pleasure or enjoyment (anhedonia) in people with major depression who have not responded to other treatments.

Who is the study for?

This trial is for individuals who have major depressive disorder that hasn't improved with standard treatments. Participants should be experiencing anhedonia, which is the inability to feel pleasure.Check my eligibility

What is being tested?

The study is testing the effects of psilocybin on depression symptoms. Two different doses of psilocybin (1mg and 25mg) are being compared to see how they affect anhedonia in participants.See study design

What are the potential side effects?

Psilocybin may cause headaches, nausea, increased heart rate, mood changes, and altered perception during treatment. Long-term side effects are still being studied.

Eligibility Criteria

Inclusion Criteria

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

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I am 21 years old or older.

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My depression hasn't improved after trying two or more antidepressants for at least 6 weeks each.

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I have someone to take me home safely after treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one, four, and eight weeks post-dosing

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one, four, and eight weeks post-dosing

This trial's timeline: 3 weeks for screening, Varies for treatment, and one, four, and eight weeks post-dosing for reporting.

Treatment Details

Study Objectives

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

Secondary outcome measures

Change from baseline in depression scores as measured by self-report on the Quick Inventory of Depressive Symptomatology (QIDS-SR-16).

Change from baseline in depression scores of the clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS).

Change from baseline in nucleus accumbens neural activation during expectation of reward versus expectation of non-reward during the Monetary Incentive Delay Task (MID).

+3 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

Fungal infection

Pyrexia

Hypoesthesia

Oedema

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

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PsilocybinExperimental Treatment1 Intervention

Participants receive Psilocybin 25mg capsule orally, administered with psychological support, on dosing day.

Group II: Active PlaceboPlacebo Group1 Intervention

Participants receive Psilocybin 1mg capsule (identical to the Psilocybin 25mg capsule) orally, administered with psychological support, on dosing day.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,732 Previous Clinical Trials

2,143,508 Total Patients Enrolled

Andrew M Novick, MD, PhDPrincipal InvestigatorUniversity of Colorado - Anschutz Medical Campus

Frequently Asked Questions

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

Are there any ongoing efforts to enroll participants for this research study at the present time?

"According to information available on clinicaltrials.gov, this particular trial is not currently accepting new participants. The trial was originally posted on March 1st, 2024 and its most recent update occurred on January 19th, 2024. However, it's worth noting that there are currently 1384 other trials actively recruiting participants at this time."

Answered by AI

Has the Food and Drug Administration officially sanctioned the use of psilocybin?

"Psilocybin's safety is rated as 2 on a scale of 1 to 3 by our team at Power for this Phase 2 trial, indicating that there is limited data supporting its safety but none supporting efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Psilocybin for Treatment-Resistant Depression

2024. "Psilocybin for Treatment-Resistant Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06230757.