- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05624528
A Clinical Trial of Tolcapone in Obsessive Compulsive Disorder
A Double-Blind, Randomized, Placebo-Controlled Study of Tolcapone for OCD
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Madison P Collins, BA
- Phone Number: 773-834-3778
- Email: mcollins4@bsd.uchicago.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- Recruiting
- University of Chicago Medical Center
-
Contact:
- Madison Collins, BA
- Phone Number: 773-834-3778
- Email: mcollins4@bsd.uchicago.edu
-
Contact:
- Sophie Boutouis, BS
- Phone Number: 773-702-9066
- Email: sboutouis@bsd.uchicago.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Men and women age 18-65 years
- Primary diagnosis of OCD
- YBOCS score of at least 21 at baseline (moderate or higher severity)
- Ability to understand and sign the consent form
Exclusion Criteria:
- Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination
- Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)
- History of psychosis or bipolar disorder based on DSM-5 criteria
- Alcohol/substance use disorder and/or illegal substance use based on urine toxicology
- Initiation of psychological interventions within 3 months of screening (those who are continuing with CBT will be included)
- Use of any new psychotropic medication within 3 months of study entry (stable doses of psychotropics will be allowed)
- Major cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent
- Abnormal liver function tests at baseline
- MADRS >30 at baseline
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tolcapone
100mg of tolcapone twice daily for two weeks, then 200mg tolcapone twice daily for the remaining six weeks.
|
catechol-O-methyl transferase inhibitor
Other Names:
|
Placebo Comparator: Placebo
100mg of placebo twice daily for two weeks, then 200mg of placebo twice daily for the remaining six weeks.
|
Pill that contains no medicine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Yale Brown Obsessive Compulsive Scale (YBOCS)
Time Frame: Baseline to Week 8
|
A measure of OCD illness severity
|
Baseline to Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CANTAB Cognitive Testing
Time Frame: Baseline to Week 8
|
Neuropsychological tasks that measure cognition
|
Baseline to Week 8
|
Val-158-Met polymorphism
Time Frame: Baseline to Week 8
|
Evaluating whether the single nucleotide polymorphism (SNP) Val-158-Met polymorphism significantly relates to changes in symptoms and cognition observed with tolcapone.
|
Baseline to Week 8
|
Quality of Life Inventory
Time Frame: Baseline to Week 8
|
A self-report measure assessing perceived quality of life.
|
Baseline to Week 8
|
Montgomery-Asberg Depression Rating Scale
Time Frame: Baseline to Week 8
|
A 10-item clinical rated scale measuring depression severity.
|
Baseline to Week 8
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jon E Grant, MD, JD, MPH, University of Chicago
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB22-1729
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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