Efficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive Disorder

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Trial ID: NCT04641143

Purpose

The study's purpose is to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in subjects with Obsessive Compulsive Disorder (OCD)

Official Title

A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder

Stanford Investigator(s)

Carolyn Rodriguez
Carolyn Rodriguez

Professor of Psychiatry and Behavioral Sciences (Public Mental Health and Population Sciences)

Eligibility


Inclusion Criteria:

   1. Primary diagnosis of obsessive-compulsive disorder (OCD) as per Diagnostic and
   Statistical Manual of Mental Disorders, Fifth Edition as confirmed by the MINI at
   Screening; The duration of the subject's illness must be ≥ 1 year

   2. An inadequate response to current Standard of Care medication defined as selective
   serotonin reuptake inhibitor (excluding fluvoxamine) or clomipramine treatment at an
   adequate and stable dose for at least 8 weeks prior to screening and at least 12 weeks
   at baseline (adequate dose defined by USPI labeling); an inadequate response as
   defined per the MGH-TRQ-OCD, there has been minimal or no meaningful clinical benefit
   as perceived by the subject

   3. Determined by the investigator to be medically stable at baseline/randomization as
   assessed by medical history, physical examination, laboratory test results, and
   electrocardiogram testing. Subjects must be physically able and expected to complete
   the trial as designed

Exclusion Criteria:

   1. Subjects with a history of more than two (2) previous failed or inadequate treatment
   classes given for an adequate duration at an adequate dose as defined by the
   MGH-TRQ-OCD.

   2. Current or prior history of: bipolar I or II disorder, schizophrenia or other
   psychotic disorders, schizoaffective disorder, autism or autistic spectrum disorders,
   borderline personality disorder, antisocial personality disorder, Tourette's disorder,
   body dysmorphic disorder, hoarding disorder; or psychosurgery, Deep Brain Stimulation
   (DBS) or Electroconvulsive Therapy (ECT); or general medical condition that may
   confound safety and/or efficacy results

   3. Previous treatment in a study with troriluzole

Intervention(s):

drug: Troriluzole

drug: Placebo

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Pavithra Mukunda
650-497-2578