What side effects are associated with this type of intervention?

Common treatments for Obsessive-Compulsive Disorder (OCD) and their side effects include: Tolcapone (a COMT inhibitor) is being studied for its efficacy and safety in OCD. Fluvoxamine, an SSRI, can cause nausea, insomnia, decreased motivation, and sedation. Agomelatine may lead to nausea, headache, dizziness, and somnolence. Memantine has shown significant improvement in OCD symptoms but specific side effects were not detailed. Celecoxib, when used adjunctively with SSRIs, can further improve OCD symptoms, though specific side effects were not mentioned. N-acetylcysteine (NAC) was well tolerated with only mild adverse events reported. Overall, gastrointestinal distress is a common side effect across various treatments.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Obsessive-Compulsive Disorder (OCD), primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, fluvoxamine, sertraline, and paroxetine, as well as the tricyclic antidepressant clomipramine. These medications work by increasing serotonin levels in the brain, which helps reduce OCD symptoms. While the trial of tolcapone, a COMT inhibitor, is being studied for its efficacy in OCD, there is no specific mention of prior FDA approvals for COMT inhibitors in the treatment of OCD in the provided context.

What other types of research exist?

Promising novel alternatives to Tolcapone for OCD treatment include: 1) Citalopram, especially when combined with Clomipramine, as it has shown efficacy in treatment-resistant OCD. 2) Memantine, although it did not show efficacy as an adjunct to Sertraline, it might still be considered for its potential cognitive benefits. 3) Olanzapine/Samidorphan combination, which can help manage weight gain associated with antipsychotic treatment. These alternatives should be discussed with a healthcare provider to tailor the best treatment plan for the patient.

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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

Awards & highlights

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 8

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

Do I qualify?Apply below to find out

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

1,034 Previous Clinical Trials

753,609 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

~30 spots leftby Jun 2025

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