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Troriluzole for Obsessive-Compulsive Disorder
Study Summary
This trial will compare the effectiveness of BHV-4157 to a placebo in people with OCD.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 3 trial • 881 Patients • NCT03829241Trial Design
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- I am currently taking an SSRI, clomipramine, venlafaxine, or desvenlafaxine.Subjects must be able to understand and agree to comply with the prescribed dosage regimens and procedures; report for regularly scheduled office visits; and reliably communicate with study personnel about adverse events and concomitant medications.I agree to use two forms of birth control during the study.I do not have any mental or physical health conditions that could explain my OCD symptoms.My current medication is not working well enough for my condition.Your obsessive-compulsive disorder (OCD) symptoms must be moderate to severe, with a score of at least 19 on a specific test.You must have moderate to severe symptoms of OCD, which will be measured by a questionnaire called Y-BOCS at Screening and Baseline.I have tried at least 3 different depression medications without success.I have a history of certain mental health conditions like bipolar disorder or schizophrenia.My current medication for OCD isn't working well, and my symptoms are severe.I have at least 6 years of education and am fluent in English.I have not had TMS in the last 3 months and am open to it during the study.My health is stable based on recent exams and tests.I agree to use two forms of birth control during the study.I was treated for a localized cancer within the last 5 years.I can follow treatment plans, attend appointments, and communicate about side effects.I have been on the same mental health medication for at least 12 weeks.I have had psychosurgery, DBS, or ECT.My heart's electrical activity is normal and does not prevent me from joining the study.I have been diagnosed with OCD according to DSM-5.I agree to use two forms of birth control during and for 90 days after the study.I can hear, see, and communicate well enough to undergo tests and interviews.I agree to use two forms of birth control during and for 90 days after the study.I can hear, see, and communicate well enough to undergo tests and interviews.I have been treated with riluzole before.I agree to use two forms of birth control during the study.I am currently taking an SSRI, clomipramine, venlafaxine, or desvenlafaxine.I have had OCD for at least a year.I can hear, see, and communicate well enough to undergo tests and interviews.I have been diagnosed with OCD.
- Group 1: Troriluzole
- Group 2: Placebo
- 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.
Frequently Asked Questions
Is this clinical research only being conducted with individuals above a certain age?
"The age range for eligible participants in this trial are individuals who are 18 years old or older, but younger than 65."
Are people still being accepted into the program?
"No, this particular trial is not accepting patients at the moment. Although it was last updated on October 4th, 2022, the study has not been actively recruiting since December 19th, 2017 according to clinicaltrials.gov. There are plenty of other opportunities for interested individuals though; 116 other trials are currently looking for participants."
Do numerous facilities in the United States offer this kind of clinical trial to patients?
"This clinical trial is enrolling patients at 57 sites. The locations of these centres include major cities such as Charlotte, Boston and Dallas. There are also many other options available to limit travel if necessary."
Could I possibly qualify to take part in this research?
"This study is looking for 248 patients with obsessive-compulsive disorder (OCD) between the ages of 18 and 65. To be eligible, subjects must: - Be able to understand and agree to comply with the prescribed dosage regimens and procedures; - Report for regularly scheduled office visits; - Reliably communicate with study personnel about adverse events and concomitant medications; - Have adequate hearing, vision, and language skills to perform neuropsychiatric testing and interviews as specified in the protocol; - Y-BOCS total score must be ≥ 19 at Screening and Baseline"
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