Tolcapone in Obsessive Compulsive Disorder

• Status: Completed
• Trial end date: 2020-12-14
• Target enrollment: 0
• Participant gender: All

Summary

The proposed study will consist of a 5-week double-blind cross-over study trial of tolcapone in 20 people (ages 18-65). The study will be divided into an initial 2 week phase and a second 2 week phase, with one of the 2 week phases consisting of active treatment with tolcapone, and the other 2 week phase consisting of inactive placebo treatment. There will be a one-week wash-out phase between the 2-week treatment phases. Participants will be randomized to receive either tolcapone or placebo during the first 2 week phase on a 1:1 basis. This blinding will be maintained by the IDS pharmacy at the University of Chicago.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Treatments: Tolcapone

Criteria

Inclusion Criteria:

1. Males and females age 18-65;

2. Diagnosis of current OCD based on DSM-5 criteria and confirmed using the clinician-administered Structured Clinical Interview for DSM-5 (SCID);

3. Able and willing to provide written consent for participation.

Exclusion Criteria:

1. Unstable medical illness, including liver disease, as determined by the investigator;

2. History of seizures;

3. Clinically significant suicidality (defined by the Columbia Suicide Severity Rating Scale);

4. Baseline score of ≥17 on the Hamilton Depression Rating Scale (17-item HDRS);

5. Lifetime history of bipolar disorder type I or II, schizophrenia, autism, any psychotic disorder, or any substance use disorder;

6. Initiation of psychotherapy or behavior therapy within 3 months prior to study baseline;

7. Previous treatment with tolcapone;

8. Any history of psychiatric hospitalization in the past year;

9. Currently pregnant (confirmed by urine pregnancy test)