← Back to Search

Psychedelic

Psilocybin for Depression

Phase 2

Recruiting

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)

Must not have

Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or EKG that in the opinion of the study physician would preclude safe participation in the trial. Some examples include: Congestive heart failure, Clinically significant arrhythmias (e.g. ventricular fibrillation, torsades) or clinically significant EKG abnormality (i.e. QTC interval > 450), Recent acute myocardial infarction or evidence of ischemia, Malignant hypertension, Congenital long QT syndrome, Acute renal failure, Severe hepatic impairment, Respiratory failure, Risk for hypertensive crisis defined as Screening, Baseline, and Medication Session (prior to dosing) Blood Pressure >140/90 mmHg, High resting heart rate defined as Screening, Baseline, and Medication Session (prior to dosing) heart of rate of >90 BPM

Significant CNS pathology as determined by self-report and confirmed by a history and physical examination and review of medical records. Current and historical psychiatric disorders will be determined by the MINI. Specific examples include: Primary or secondary cerebral neoplasm, Epilepsy, History of stroke, Cerebral aneurysm, Dementia, Delirium, Post-traumatic Stress Disorder, Current or lifetime primary psychotic disorder, bipolar affective disorder, affective disorder with psychotic features. Some examples include: Schizophrenia spectrum disorders, Schizoaffective disorder, Bipolar I or Bipolar II disorder, History of mania, Major depressive disorder with psychotic features

Timeline

Screening 3 weeks

Treatment Varies

Follow Up eight weeks post-dosing

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.

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.

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

Select...

I am 21 years old or older.

Select...

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

Select...

I have someone to take me home safely after treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any serious heart, liver, kidney, or blood pressure conditions that would make it unsafe for me to join the trial.

Select...

I have a significant brain condition or mental health issue confirmed by medical review.

Select...

A close family member has had a serious mental health condition like schizophrenia or bipolar.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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

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 / 6Eligibility criteria met