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Tolcapone for Obsessive-Compulsive Disorder

Phase 2
Recruiting
Led By Jon E Grant, MD, JD, MPH
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 8

Summary

This trial is testing tolcapone, a medication that may help reduce symptoms of OCD by affecting dopamine levels in the brain. It targets adults with moderate to severe OCD who have significant symptoms. The study also looks at how tolcapone might improve thinking skills and whether genetic differences affect its effectiveness. Tolcapone has been investigated for its potential cognitive benefits in healthy adults.

Who is the study for?
This trial is for adults aged 18-65 with moderate to severe Obsessive Compulsive Disorder (OCD), evidenced by a YBOCS score of at least 21. Participants must understand and sign the consent form, not be pregnant or breastfeeding, have no alcohol/substance abuse issues, stable psychotropic medication use if any, normal liver function, and no major cognitive impairments.
What is being tested?
The study is testing the effectiveness and safety of Tolcapone in treating OCD. Participants will either receive Tolcapone or a placebo to compare outcomes. The goal is to see if Tolcapone can help reduce the symptoms of OCD more effectively than a non-active treatment.
What are the potential side effects?
Tolcapone may cause side effects such as trouble sleeping, nausea, headache, dizziness, fatigue or liver problems. Since it's being tested against a placebo which has no active ingredients, any additional side effects observed could be attributed to Tolcapone.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Yale Brown Obsessive Compulsive Scale (YBOCS)
Secondary study objectives
CANTAB Cognitive Testing
Montgomery-Asberg Depression Rating Scale
Quality of Life Inventory
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TolcaponeExperimental Treatment1 Intervention
100mg of tolcapone twice daily for two weeks, then 200mg tolcapone twice daily for the remaining six weeks.
Group II: PlaceboPlacebo Group1 Intervention
100mg of placebo twice daily for two weeks, then 200mg of placebo twice daily for the remaining six weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tolcapone
2014
Completed Phase 2
~630

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Obsessive-Compulsive Disorder (OCD) include selective serotonin reuptake inhibitors (SSRIs) and cognitive-behavioral therapy (CBT) with exposure and response prevention (ERP). SSRIs work by increasing serotonin levels in the brain, which helps reduce OCD symptoms by improving mood and anxiety regulation. CBT, particularly ERP, helps patients confront and manage their obsessions and compulsions through structured exposure to anxiety-provoking stimuli and prevention of the associated compulsive behaviors. Augmentation strategies, such as the use of antipsychotics or other medications, are sometimes employed when patients do not fully respond to SSRIs alone. Tolcapone, a COMT inhibitor, is being studied for its potential to enhance dopamine levels, which may offer another avenue for symptom relief in OCD patients. Understanding these mechanisms is crucial as it helps tailor treatment plans to individual needs, potentially improving outcomes and quality of life for those with OCD.
Beyond refractory obsessions and anxiety states: toward remission.

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,062 Previous Clinical Trials
840,049 Total Patients Enrolled
3 Trials studying Obsessive-Compulsive Disorder
49 Patients Enrolled for Obsessive-Compulsive Disorder
Jon E Grant, MD, JD, MPHPrincipal InvestigatorUniversity of Chicago
9 Previous Clinical Trials
393 Total Patients Enrolled
1 Trials studying Obsessive-Compulsive Disorder
15 Patients Enrolled for Obsessive-Compulsive Disorder

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05624528 — Phase 2
Obsessive-Compulsive Disorder Research Study Groups: Tolcapone, Placebo
Obsessive-Compulsive Disorder Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05624528 — Phase 2
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05624528 — Phase 2
Obsessive-Compulsive Disorder Patient Testimony for trial: Trial Name: NCT05624528 — Phase 2
~18 spots leftby Jun 2025