Psilocybin for Treatment-Resistant Depression

Completed · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder, Anhedonia, Treatment Resistant Depression

In brief

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.

Key facts

Study ID: NCT06230757
Run by: University of Colorado, Denver
People needed: 20
Starts: 2024-07-08
Expected to finish: 2026-05-08
Last updated by the study team: 2026-05-22

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
Written informed consent obtained from participant and ability for subject to comply with the requirements of the study.
Ability to abstain from caffeine and nicotine for 2 hours prior to fMRI scan visits

You may not qualify if…

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
h. Current or lifetime primary psychotic disorder, bipolar affective disorder, affective disorder with psychotic features. Some examples include: i. Schizophrenia spectrum disorders j. Schizoaffective disorder k. Bipolar I or Bipolar II disorder l. History of mania m. Major depressive disorder with psychotic features
Family history of first-degree relative with psychotic or serious bipolar spectrum illnesses. Examples include first-degree relative with:
Schizophrenia spectrum disorders
Schizoaffective disorder
Bipolar I disorder with psychotic features
High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation. Examples include:
Agitation

Where it is running

University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.