Tolcapone in Obsessive Compulsive Disorder

March 16, 2022 updated by: University of Chicago

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tolcapone
Each subject will have a 4 week treatment phase with Tolcapone
Drug: Tolcapone 200 MG
All eligible study subjects will go through a 2-week treatment phase during which they will begin tolcapone at 100mg twice a day.
Other Names:
  • No other names
Placebo Comparator: Placebo
4 week placebo phase before or after Tolcapone phase depending on randomization.
Drug: Tolcapone 200 MG
All eligible study subjects will go through a 2-week treatment phase during which they will begin tolcapone at 100mg twice a day.
Other Names:
  • No other names

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Yale Brown Obsessive Compulsive Scale (Y-BOCS)
Time Frame: 2 weeks (start of study to washout period OR two weeks following washout period)
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.
2 weeks (start of study to washout period OR two weeks following washout period)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression- Severity and Improvement (CGI)
Time Frame: 2 weeks (start of study to washout period OR two weeks following washout period)
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"
2 weeks (start of study to washout period OR two weeks following washout period)
Sheehan Disability Scale (SDS)
Time Frame: 2 weeks (start of study to washout period OR two weeks following washout period)
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).
2 weeks (start of study to washout period OR two weeks following washout period)
Hamilton Anxiety Rating Scale (HAM-A)
Time Frame: 2 weeks (start of study to washout period OR two weeks following washout period)
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.
2 weeks (start of study to washout period OR two weeks following washout period)
Hamilton Depression Rating Scale (HAM-D)
Time Frame: 2 weeks (start of study to washout period OR two weeks following washout period)
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.
2 weeks (start of study to washout period OR two weeks following washout period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Jon E Grant, JD,MD,MPH, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2018

Primary Completion (Actual)

December 14, 2020

Study Completion (Actual)

December 14, 2020

Study Registration Dates

First Submitted

November 15, 2017

First Submitted That Met QC Criteria

November 16, 2017

First Posted (Actual)

November 21, 2017

Study Record Updates

Last Update Posted (Actual)

April 7, 2022

Last Update Submitted That Met QC Criteria

March 16, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-1379

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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