A Clinical Trial of Tolcapone in Obsessive Compulsive Disorder

NCT05624528 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IRB22-1729
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obsessive-Compulsive Disorder; OCD

Outcome Measures

Primary Outcomes (1)

• Yale Brown Obsessive Compulsive Scale (YBOCS)

  A measure of OCD illness severity

  Baseline to Week 8

Secondary Outcomes (4)

• CANTAB Cognitive Testing

  Baseline to Week 8

• Val-158-Met polymorphism

  Baseline to Week 8

• Quality of Life Inventory

  Baseline to Week 8

• Montgomery-Asberg Depression Rating Scale

  Baseline to Week 8

Study Arms (2)

Tolcapone

EXPERIMENTAL

100mg of tolcapone twice daily for two weeks, then 200mg tolcapone twice daily for the remaining six weeks.

Drug: Tolcapone

Placebo

PLACEBO COMPARATOR

100mg of placebo twice daily for two weeks, then 200mg of placebo twice daily for the remaining six weeks.

Drug: Placebo

Interventions

Tolcapone DRUG

catechol-O-methyl transferase inhibitor

Also known as: Tasmar

Tolcapone

Placebo DRUG

Pill that contains no medicine

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Tolcapone

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitrophenols; Phenols; Ketones; Nitro Compounds

Study Officials

• Jon E Grant, MD, JD, MPH

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 22, 2022
• Study Start: June 22, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)