Tolcapone in Obsessive Compulsive Disorder

The University of Chicago

Status and phase: Completed; Phase 3; Phase 2

Conditions: Obsessive-Compulsive Disorder

Treatments: Drug: Tolcapone 200 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT03348930

17-1379

Details and patient eligibility

About

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.

Full 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 effective and well tolerated in adults with OCD compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder where current treatments are often ineffective.

The primary aim of this application is to conduct a randomized placebo-controlled pharmacotherapy trial using tolcapone in 20 participants with OCD. The study will consist of two phases: a 2 week active treatment phase with tolcapone, a one-week wash-out phase, and a 2 week placebo phase. The subjects will be randomized to either receive tolcapone or placebo treatment in the first 2 weeks, and the other during the remaining 2 week phase.

This will be one of few studies assessing the use of pharmacotherapy for the treatment of OCD in adults. Assessing the efficacy and safety of tolcapone will help inform clinicians about additional treatment options for adults suffering from this disorder.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

20 participants in 2 patient groups, including a placebo group

Tolcapone

Experimental group

Description:

Each subject will have a 4 week treatment phase with Tolcapone

Treatment:

Drug: Tolcapone 200 MG

Placebo

Placebo Comparator group

Description:

4 week placebo phase before or after Tolcapone phase depending on randomization.

Treatment:

Drug: Tolcapone 200 MG