Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
20 participants
INTERVENTIONAL
2018-03-20
2020-12-14
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Tolcapone
Each subject will have a 4 week treatment phase with Tolcapone
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
4 week placebo phase before or after Tolcapone phase depending on randomization.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
65 Years
ALL
No
Sponsors
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University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Jon E Grant, JD,MD,MPH
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Chicago
Chicago, Illinois, United States
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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17-1379
Identifier Type: -
Identifier Source: org_study_id
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