Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06230757
Other study ID # 22-1681
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date March 1, 2024
Est. completion date March 1, 2025

Study information

Verified date January 2024
Source University of Colorado, Denver
Contact Lily C Vonesh, BA
Phone 3037240658
Email lily.vonesh@cuanschutz.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Psilocybin 25mg
25mg psilocybin capsule
Placebo (active placebo)
1mg psilocybin capsule

Locations

Country Name City State
United States University of Colorado Anschutz Medical Campus Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in self-reported anhedonia scores on the Dimensional Anhedonia Rating Scale (DARS). The DARS is a 17-item scale that captures multiple domains of anhedonia found in depression. Scores range from 0 to 68 with lower scores indicating greater anhedonia and 68 indicating no anhedonia. One week post-dosing
Secondary Change from baseline in self-reported anhedonia scores on the Dimensional Anhedonia Rating Scale (DARS). The DARS is a 17-item scale that captures multiple domains of anhedonia found in depression. Scores range from 0 to 68 with lower scores indicating greater anhedonia and 68 indicating no anhedonia. Eight weeks post-dosing
Secondary Change from baseline in self-reported anhedonia scores on the Snaith-Hamilton Pleasure Scale (SHAPS). The SHAPS is a 14-item scale that assesses the pleasure component of hedonic experience across multiple domains. Scores range from 0 to 14 with 0 indicating no anhedonia and high scores indicating greater anhedonia. One week and eight weeks post-dosing
Secondary Change from baseline in response bias for the high reward condition on the Probabilistic Reward Task (PRT) The PRT is a behavioral task that assesses the capacity to develop a response bias towards more highly rewarded stimuli, in which individuals with MDD demonstrate reduced bias towards highly rewarded stimuli. One and eight weeks post-dosing
Secondary Change from baseline in nucleus accumbens neural activation during expectation of reward versus expectation of non-reward during the Monetary Incentive Delay Task (MID). The MID is used in conjunction with fMRI to assess neural activity during reward processing and reliably induces neural activation in brain regions related to reward. One week post-dosing
Secondary Change from baseline in depression scores of the clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS). The MADRS is a standard 10-item clinician-rated scale that assesses severity of depression in anti-depressant trials. Scores range form 0-60, with scores of 0-6 indicating no depression, 7-19 indicating mild depression, 20-34 indicating moderate depression and 35 or greater indicating severe depression. One and eight weeks post-dosing
Secondary Change from baseline in depression scores as measured by self-report on the Quick Inventory of Depressive Symptomatology (QIDS-SR-16). The QIDS-SR-16 is a widely used 16-item self-report scale of depressive symptoms. Scores range form 0-27, with scores of 0-5 indicating no depression, 6-10 indicating mild depression, 11-15 indicating moderate depression, 16-20 indicating severe depression, and 21-27 indicating very severe depression. One, four, and eight weeks post-dosing
See also
  Status Clinical Trial Phase
Recruiting NCT05537558 - Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
Terminated NCT02192099 - Open Label Extension for GLYX13-C-202, NCT01684163 Phase 2
Completed NCT03142919 - Lipopolysaccharide (LPS) Challenge in Depression Phase 2
Recruiting NCT05547035 - Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders N/A
Terminated NCT02940769 - Neurobiological Effects of Light on MDD N/A
Recruiting NCT05892744 - Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression Phase 4
Recruiting NCT05537584 - SMART Trial to Predict Anhedonia Response to Antidepressant Treatment Phase 4
Active, not recruiting NCT05061706 - Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder Phase 3
Completed NCT04479852 - A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder Phase 2
Recruiting NCT04032301 - Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans Phase 1
Recruiting NCT05527951 - Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study N/A
Completed NCT03511599 - Cycloserine rTMS Plasticity Augmentation in Depression Phase 1
Recruiting NCT04392947 - Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation N/A
Recruiting NCT05895747 - 5-HTP and Creatine for Depression R33 Phase Phase 2
Recruiting NCT05273996 - Predictors of Cognitive Outcomes in Geriatric Depression Phase 4
Recruiting NCT05813093 - Interleaved TMS-fMRI in Ultra-treatment Resistant Depression N/A
Recruiting NCT05135897 - The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
Enrolling by invitation NCT04509102 - Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder Early Phase 1
Recruiting NCT06145594 - EMA-Guided Maintenance TMS for Depression N/A
Recruiting NCT06026917 - Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET) Phase 4