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Psilocybin for Treatment-Resistant Depression | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Psilocybin for Treatment-Resistant Depression

Effects of Psilocybin With Psychological Support on Anhedonia in Treatment-resistant Depression: a Randomized Controlled Pilot Trial

NCT06230757•University of Colorado, Denver

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy of psilocybin on the symptom of anhedonia in individuals with treatment-resistant major depressive disorder.

Eligibility

Age

21 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adults ≥ 21 years of age at Screening
•Diagnosis of Major Depressive Disorder (MDD)
•Score of at least 12 (symptomatic depression) on administration of the Montgomery Asberg Depression Rating Scale (MADRS)
•Score of at least a 3 on question 8 on the MADRS evaluating loss of interest and ability to feel at both Screening and 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)
•Sufficiently competent in English Language
•Currently under the care of a psychiatric practitioner (MD, DO, NP, PA) OR under the consistent care of a clinician within the UCHealth/CUMedicine health system (for example, primary care provider, neurologist, therapist). Participants engaged in additional psychosocial treatments beyond seeing a psychiatric practitioner or regular therapist will be evaluated on a case by case basis.
•Right-handed
•Women of childbearing potential (WOCBP) must agree to practice an effective means of birth control throughout the duration of the study. A person of childbearing potential is anyone born female who has experienced menarche and who has not undergone surgical sterilization (eg, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or has not completed menopause. Menopause is defined clinically as 12 months of amenorrhea in a person over age 45 in the absence of other biological, physiological, or pharmacological causes.
•Have an identified support person and agree to be accompanied home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing
+2 more criteria

Exclusion Criteria

•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:
•1. Congestive heart failure
•2. Clinically significant arrhythmias (e.g. ventricular fibrillation, torsades) or clinically significant EKG abnormality (i.e. QTC interval \> 450)
•3. Recent acute myocardial infarction or evidence of ischemia
•4. Malignant hypertension
•5. Congenital long QT syndrome
•6. Acute renal failure
•7. Severe hepatic impairment
•8. Respiratory failure
•Risk for hypertensive crisis defined as Screening, Baseline, and Medication Session (prior to dosing) Blood Pressure \>140/90 mmHg.
+53 more criteria

Locations (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Key Dates

Start Date

July 8, 2024

Primary Completion Date

March 1, 2026

Completion Date

March 1, 2026

Last Updated

January 21, 2026

Enrollment

ESTIMATED participants

Conditions

Major Depressive DisorderAnhedoniaTreatment Resistant Depression

Interventions

Psilocybin 25mg

DRUG

Placebo (active placebo)

DRUG

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

NCT07115329

Major Depressive Disorder

View study

RECRUITINGPHASE3

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

NCT06793397

Major Depressive Disorder (MDD)Depression in Adults+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Psilocybin for Treatment-Resistant Depression

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

University of Iowa Interventional Psychiatry Service Patient Registry

Virtual Reality-Based Mindfulness as an Adjunct to Treatment as Usual in Treatment-Resistant Depression