Phase 3
N=20
Tolcapone in Obsessive Compulsive Disorder
Obsessive-Compulsive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03348930 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Yale Brown Obsessive Compulsive Scale (Y-BOCS) — -4.24; -1.10 mean change in YBOCS score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tolcapone 200 MG (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Yale Brown Obsessive Compulsive Scale (Y-BOCS) |
-4.24; -1.10 | — |
| SECONDARY Clinical Global Impression- Severity and Improvement (CGI) |
3.78; 3.5 | — |
| SECONDARY Sheehan Disability Scale (SDS) |
-2.68; -1.97 | — |
| SECONDARY Hamilton Anxiety Rating Scale (HAM-A) |
-1.90; -1.60 | — |
| SECONDARY Hamilton Depression Rating Scale (HAM-D) |
-1.65; -2.00 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT03348930). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.