Status:
COMPLETED
Tolcapone in Obsessive Compulsive Disorder
Lead Sponsor:
University of Chicago
Conditions:
Obsessive-Compulsive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
The goal of the proposed study is to evaluate the efficacy and safety of tolcapone in adults with obsessive compulsive disorder (OCD). The hypothesis to be tested is that tolcapone will be more effect...
Eligibility Criteria
Inclusion
- Males and females age 18-65;
- Diagnosis of current OCD based on DSM-5 criteria and confirmed using the clinician-administered Structured Clinical Interview for DSM-5 (SCID);
- Able and willing to provide written consent for participation.
Exclusion
- Unstable medical illness, including liver disease, as determined by the investigator;
- History of seizures;
- Clinically significant suicidality (defined by the Columbia Suicide Severity Rating Scale);
- Baseline score of ≥17 on the Hamilton Depression Rating Scale (17-item HDRS);
- Lifetime history of bipolar disorder type I or II, schizophrenia, autism, any psychotic disorder, or any substance use disorder;
- Initiation of psychotherapy or behavior therapy within 3 months prior to study baseline;
- Previous treatment with tolcapone;
- Any history of psychiatric hospitalization in the past year;
- Currently pregnant (confirmed by urine pregnancy test)
Key Trial Info
Start Date :
March 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03348930
Start Date
March 20 2018
End Date
December 14 2020
Last Update
April 7 2022
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637