RECRUITING

A Clinical Trial of Tolcapone in Obsessive Compulsive Disorder

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Double-Blind, Randomized, Placebo-Controlled Study of Tolcapone for OCD

Quick Facts

Study Start:2023-06-22

Study Completion:2025-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05624528

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Men and women age 18-65 years 2. Primary diagnosis of OCD 3. YBOCS score of at least 21 at baseline (moderate or higher severity) 4. Ability to understand and sign the consent form	1. Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination 2. Current pregnancy or lactation, or inadequate contraception in women of childbearing potential 3. Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs) 4. History of psychosis or bipolar disorder based on DSM-5 criteria 5. Alcohol/substance use disorder and/or illegal substance use based on urine toxicology 6. Initiation of psychological interventions within 3 months of screening (those who are continuing with CBT will be included) 7. Use of any new psychotropic medication within 3 months of study entry (stable doses of psychotropics will be allowed) 8. Major cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent 9. Abnormal liver function tests at baseline 10. MADRS \>30 at baseline

Inclusion Criteria

Exclusion Criteria

1. Men and women age 18-65 years
2. Primary diagnosis of OCD
3. YBOCS score of at least 21 at baseline (moderate or higher severity)
4. Ability to understand and sign the consent form

1. Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination
2. Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
3. Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)
4. History of psychosis or bipolar disorder based on DSM-5 criteria
5. Alcohol/substance use disorder and/or illegal substance use based on urine toxicology
6. Initiation of psychological interventions within 3 months of screening (those who are continuing with CBT will be included)
7. Use of any new psychotropic medication within 3 months of study entry (stable doses of psychotropics will be allowed)
8. Major cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent
9. Abnormal liver function tests at baseline
10. MADRS \>30 at baseline

Contacts and Locations

Study Contact

Sophie Boutouis, BS

CONTACT

773-702-9066

sboutouis@bsd.uchicago.edu

Laurie Avila, BA

CONTACT

773-702-5523

laurie.avila@bsd.uchicago.edu

Principal Investigator

Jon E Grant, MD, JD, MPH

PRINCIPAL_INVESTIGATOR

University of Chicago

Study Locations (Sites)

University of Chicago Medical Center

Chicago, Illinois, 60637

United States

Collaborators and Investigators

Sponsor: University of Chicago

Jon E Grant, MD, JD, MPH, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-22

Study Completion Date2025-07

Study Record Updates

Study Start Date2023-06-22

Study Completion Date2025-07

Terms related to this study

Additional Relevant MeSH Terms

Obsessive-Compulsive Disorder
OCD