Back to results

Tolcapone in Obsessive Compulsive Disorder

Primary Purpose

Obsessive-Compulsive Disorder

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Tolcapone 200 MG

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tolcapone

Placebo

Arm Description

Each subject will have a 4 week treatment phase with Tolcapone

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

Outcomes

Primary Outcome Measures

Yale Brown Obsessive Compulsive Scale (Y-BOCS)

The entire study for the subject will last 5 weeks. Every 2 weeks and after the one week washout period the subject will take the YBOCS. The change in scores from baseline to after 5 weeks will be assessed. The scale itself assesses severity of OCD symptoms. The YBOCS scale ranges from 0 to 40, with 0 being no symptoms and 40 being severe.

Secondary Outcome Measures

Clinical Global Impression- Severity and Improvement (CGI)

The entire study for the subject will last 5 weeks. Every two weeks and after the one week washout period the subject will complete the CGI. The change in scores from baseline to after 5 weeks will be assessed. The scale itself assesses overall disorder severity on a scale from 1 to 7 with 1 being "not at all" and 7 being "among the most severe cases"

Sheehan Disability Scale (SDS)

The entire study for the subject will last 5 weeks. Every two weeks and after the one week washout period the subject will complete the SDS. The change in scores from baseline to after 5 weeks will be assessed. The scale itself assesses the level of disability from obsessive compulsive disorder (or target disorder). The SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life. Work/school scores range from 0 to 10, Social life scores range from 0 to 10, Family life/home responsibilities scores range from 0 to 10). Total scores are calculated by adding the scores for work/school, social life, and family life. Total scores range from a minimum of 0 to a maximum of 30 (0 unimpaired, 30 highly impaired).

Hamilton Anxiety Rating Scale (HAM-A)

Every study visit, the subject will complete the HAM-A. The change in scores from baseline to after 5 weeks will be assessed. The scale itself assesses level of anxiety. Higher scores indicate higher levels of anxiety, with 0 being no symptoms of anxiety and 30 being severe anxiety.

Hamilton Depression Rating Scale (HAM-D)

The entire study for the subject will last 5 weeks. The HAM-D will be administered at every study visit. The change in scores from baseline to after the end of the 2-week active treatment period will be assessed and the change in scores from baseline to the end of the 2-week placebo period. The scale itself assesses level of depression. The minimum score is 0 and indicates no depressive symptoms, while the highest possible score is 50. Higher total scores indicate high levels of depression. Higher scores indicate a worse outcome. Higher total scored (14-50) indicate higher levels of depression, while a score between 0-7 is considered normal.

Full Information

NCT ID

NCT03348930

First Posted

November 15, 2017

Last Updated

March 16, 2022

Sponsor

University of Chicago

1. Study Identification

Unique Protocol Identification Number

NCT03348930

Brief Title

Tolcapone in Obsessive Compulsive Disorder

Official Title

Tolcapone Treatment of Obsessive Compulsive Disorder: A Double-Blind, Placebo-Controlled, Cross-Over Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

March 20, 2018 (Actual)

Primary Completion Date

December 14, 2020 (Actual)

Study Completion Date

December 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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, 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.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obsessive-Compulsive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tolcapone

Arm Type

Experimental

Arm Description

Each subject will have a 4 week treatment phase with Tolcapone

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Tolcapone 200 MG

Other Intervention Name(s)

No other names

Intervention Description

All eligible study subjects will go through a 2-week treatment phase during which they will begin tolcapone at 100mg twice a day.

Primary Outcome Measure Information:

Title

Yale Brown Obsessive Compulsive Scale (Y-BOCS)

Description

Time Frame