Clinical Trials Logo

Clinical Trial Summary

The primary aim of the present study is to examine the efficacy and safety of tolcapone in adults with moderate to severe OCD.


Clinical Trial Description

Based on the mechanism of action and our previous pilot data, the primary aim of the present study is to examine the efficacy and safety of 8-week treatment with tolcapone vs. placebo in adults with moderate to severe OCD, as indicated by a score of at least 21 on the Yale Brown Obsessive Compulsive Scale (YBOCS), a scale of illness severity, at the baseline visit. We hypothesize that tolcapone will significantly improve symptoms of OCD compared to placebo. A secondary aim of the proposed study is to examine the cognitive effects of tolcapone in OCD, by conducting objective neuropsychological tasks pre- and post-pharmacological trial. The rationale for this approach is that: dopamine plays a key role in cognition; cognitive effects of tolcapone are likely to be relevant in explaining symptomatic effects; and cognitive dysfunction constitutes an important treatment target in OCD that is not generally ameliorated by current first-line interventions. We hypothesize that any symptomatic benefit with tolcapone would also be associated with improvement in executive functions including cognitive flexibility. Another secondary aim of the proposed study is to evaluate whether the single nucleotide polymorphism (SNP) Val-158-Met polymorphism significantly relates to changes in symptoms and cognition observed with tolcapone. Prior data indicate cognitive effects of tolcapone are affected by this SNP. We hypothesize that the val/val COMT variant will be associated with significantly higher tolcapone-related improvements in cognition and symptoms, since this is linked to lower cortical dopamine function. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05624528
Study type Interventional
Source University of Chicago
Contact Madison P Collins, BA
Phone 773-834-3778
Email mcollins4@bsd.uchicago.edu
Status Recruiting
Phase Phase 2
Start date June 22, 2023
Completion date July 2025

See also
  Status Clinical Trial Phase
Recruiting NCT04934007 - Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder N/A
Recruiting NCT04071990 - Family Involvement in CBGT of OCD: a Randomized Controlled Trial N/A
Completed NCT02541968 - Internet-based vs Face-to-face Cognitive Behavioural Therapy for Obsessive-compulsive Disorder N/A
Recruiting NCT05651295 - A Precision Medicine Approach to Target Engagement for Emotion Regulation N/A
Recruiting NCT05391503 - Light Therapy for Obsessive-compulsive Disorder (OCD) N/A
Recruiting NCT04539951 - Pragmatic Trial of Obsessive-compulsive Disorder Phase 2
Completed NCT03416504 - Methods for Managing Intrusive Thoughts N/A
Not yet recruiting NCT06029738 - Effect on Obsessive-Compulsive Beliefs and Symptoms of MCT-OCD N/A
Recruiting NCT02844049 - European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS N/A
Completed NCT02911324 - Cannabinoid Medication for Adults With OCD Phase 1/Phase 2
Terminated NCT02909660 - What Are You Looking for? Psychometric and Experimental Analyses of Reassurance Seeking in Obsessive-compulsive Disorder N/A
Terminated NCT02234011 - A Trial of Intranasal Ketamine for the Treatment of Obsessive-Compulsive Disorder Phase 2
Completed NCT02217995 - Mindfulness-Based Cognitive Therapy in a Clinical Sample of OCD Patients N/A
Withdrawn NCT01953042 - Benefits of a Psychoeducation Program for Those Awaiting Treatment for OCD and OCD Spectrum Disorders N/A
Completed NCT02655926 - Deep Brain Stimulation for Severe Obsessive Compulsive Disorder N/A
Completed NCT04919785 - Deep Brain Stimulation in Severe Obsessive-compulsive Disorder N/A
Completed NCT00742664 - Behavioral Treatment of Obsessive-Compulsive Symptoms in Youth With Prader-Willi Syndrome: A Pilot Project Phase 1/Phase 2
Terminated NCT00758966 - Naltrexone SR and Fluoxetine Combination Therapy in Subjects With Obsessive-Compulsive Disorder Phase 2
Completed NCT00523718 - Riluzole Augmentation in Treatment-refractory Obsessive-compulsive Disorder Phase 2
Completed NCT00074815 - Treatment of Obsessive Compulsive Disorder in Children Phase 3