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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
Study Summary
This trial studies if a drug called tolcapone is safe and effective in adults with obsessive-compulsive disorder.
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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Yale Brown Obsessive Compulsive Scale (YBOCS)
Secondary outcome measures
CANTAB Cognitive Testing
Montgomery-Asberg Depression Rating Scale
Quality of Life Inventory
+1 moreTrial 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
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,692 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
396 Total Patients Enrolled
1 Trials studying Obsessive-Compulsive Disorder
15 Patients Enrolled for Obsessive-Compulsive Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, breastfeeding, and I use effective birth control.I can understand and manage my medication, and I can give informed consent.I am between 18 and 65 years old.I started psychological therapy within the last 3 months.My primary diagnosis is OCD.I haven't started any new mental health medications in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Tolcapone
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obsessive-Compulsive Disorder Patient Testimony for trial: Trial Name: NCT05624528 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research accept test subjects who are younger than 65?
"Individuals of legal age and below the official retirement age are eligible to take part in this medical trial."
Answered by AI
Has the Federal Drug Administration sanctioned Tolcapone for public use?
"Tolcapone received a safety rating of 2, as the Phase 2 trial has provided evidence that it is safe but there are no results currently to demonstrate its efficacy."
Answered by AI
Could I be an eligible subject for this investigation?
"In order to be accepted into this clinical trial, individuals must fall between the ages of 18 and 65 while suffering from obsessive-compulsive disorder. The study will accept 85 applicants in total."
Answered by AI
Are there any current opportunities for volunteers to join this research endeavor?
"Affirmative. The information accessible on clinicaltrials.gov verifies that this research is actively seeking participants. It was first listed on June 22nd of 2023 and the most recent update was made July 12th, 2023; it requires 85 individuals from one site to join in the study."
Answered by AI
How many participants are being allowed to participate in the experiment?
"Affirmative. By consulting clinicaltrials.gov, it can be seen that this medical trial is currently receiving applications from prospective patients and has been since June 22nd 2023 when the record was first created. It was last updated on July 12th of the same year and requires 85 participants for a single location to commence trials."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
What site did they apply to?
University of Chicago Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have had OCD my whole life and it continues to get worse. I'v tried many, many medications, therapists and psychiatrists. I even flew to Utah for Neurotherapy to no avail. I have lost relationships and friends and am worried about losing my employment because my OCD is so debilitating. I struggle leaving my house, then getting out of my car, using my phone or electronics, etc. My OCD is making my life so difficult. I am hoping to find help.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
What is the time frame? Getting chosen, starting, etc. How often will I have to drive to Chicago?
PatientReceived 1 prior treatment
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