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Tolcapone in Obsessive Compulsive Disorder

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ClinicalTrials.gov Identifier: NCT03348930
Recruitment Status : Recruiting
First Posted : November 21, 2017
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Drug: Tolcapone 200 MG Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tolcapone Treatment of Obsessive Compulsive Disorder: A Double-Blind, Placebo-Controlled, Cross-Over Pilot Study
Actual Study Start Date : March 20, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Tolcapone

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.

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.




Primary Outcome Measures :
  1. Yale Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: Up to 5 weeks ]
    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 :
  1. Clinical Global Impression- Severity and Improvement (CGI) [ Time Frame: Up to 5 weeks ]
    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. Sheehan Disability Scale (SDS) [ Time Frame: Up to 5 weeks ]
    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)

  3. Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: Up to 5 weeks ]
    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 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 being no symptoms of anxiety.

  4. Hamilton Depression Rating Scale (HAM-D) [ Time Frame: Up to 5 weeks ]
    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 HAM-D. The change in scores from baseline to after 5 weeks will be assessed. The scale itself assesses level of depression. Higher total scores indicate higher levels of depression, while a score of 0 would indicate no depressive symptoms.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348930


Contacts
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Contact: Stephanie Valle 773-843-3778 valles@uchicago.edu
Contact: Elizabeth Cavic 773-702-9066 ec642@bsd.uchicago.edu

Locations
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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Jon E Grant, JD,MD,MPH University of Chicago

Publications:
Sheehan DV. (1983). The Anxiety Disease. New York: Scribner's.
Guy W (1976). ECDEU Assessment Manual for Psychopharmacology. US Dept Health, Education and Welfare publication (ADM) 76-338. Rockville, MD: National Institute of Mental Health, 218-222.

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03348930     History of Changes
Other Study ID Numbers: 17-1379
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Personality Disorders
Disease
Obsessive-Compulsive Disorder
Pathologic Processes
Mental Disorders
Anxiety Disorders
Tolcapone
Antiparkinson Agents
Anti-Dyskinesia Agents
Catechol O-Methyltransferase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action