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New drug troriluzole tested for OCD patients not helped by antidepressants

NCT ID NCT03299166

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 2/3 trial tested whether adding troriluzole to standard antidepressant treatment can reduce OCD symptoms. 426 adults with moderate-to-severe OCD who had not responded well enough to their current medication took either troriluzole or a placebo for 12 weeks. The main goal was to see if troriluzole led to a greater drop in OCD severity scores.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
troriluzole
What this could lead to
If it works, this could offer a new add-on option for people with OCD who don't get enough relief from standard antidepressants.
What could go wrong
This is a mid-stage trial; results may show no benefit over placebo. Even if positive, it only helps as an add-on, not a standalone cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

426 people

The number who actually took part.

Started

Dec 2017

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Primary diagnosis of OCD as per the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). 2. Participants must be currently experiencing non-response or inadequate response to their current standard of care (SOC) medication defined as: 1. Participant Yale-Brown Obsessive Compulsive Scale total score must be ≥ 19 at screening and Baseline, reflecting moderate or severe OCD symptoms. 2. Participants must currently be on a SSRI, clomipramine, venlafaxine or desvenlafaxine. 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. Participants must be physically able and expected to complete the trial as designed; 4. Minimum of 6 years of education or equivalent and sufficiently fluent in English to complete necessary scales and understand consent forms; 5. Participants must have adequate hearing, vision, and language skills to perform neuropsychiatric testing and interviews as specified in the protocol; 6. Participants 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; 7. It is required that all women of child-bearing potential (WOCBP) who are sexually active agree to use two methods of contraception for the duration of the study (i.e. beginning 30 days prior to baseline and extending to 30 days after the last dose of study drug). 8. WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to dosing at Baseline; 9. It is required that men who are sexually active with WOCBP agree to use 2 methods of contraception for the duration of the study (beginning at first treatment and extending to 90 days after the last dose of study drug). 10. The duration of the subject's OCD disease was to be ≥ 1 year. 11. In addition, subjects had to be on stable doses of other psychotropic medication for at least 12 weeks prior to screening. 12. Subjects had to have a Clinical Global Impression of Severity Scale (CGI-S) score of ≥ 4 at screening and baseline. Exclusion Criteria: 1. Participants should be excluded with a history of more than 2 previous failed treatment trials of SSRIs, clomipramine, venlafaxine, or desvenlafaxine (not including the current SSRI trial) given for an adequate duration at an adequate dose as defined by the following criteria taken from the Massachusetts General Hospital Treatment Response Questionnaire for OCD (MGH-TRQ-OCD) as follows: 1. Treatment failure / non-response: As per the MGH-TRQ-OCD, there has been minimal or no meaningful clinical benefit as perceived by the participant despite an adequate dose and duration of treatment; 2. Adequate duration: At least 10 weeks of treatment with SSRI, clomipramine, venlafaxine, or desvenlafaxine 3. Adequate dose: Defined by the the United States Prescribing Information labeling. 2. Evidence at screening or baseline of any medical or psychiatric condition other than OCD that could predominantly explain or contribute significantly to the subjects' symptoms or that could confound assessment of OCD symptoms 3. Mini Mental State Examination (MMSE) score of \< 24 at Screening 4. Current or prior history, per DSM-5 criteria, of bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autistic spectrum disorders, borderline personality disorder, antisocial personality disorder, body dysmorphic disorder, hoarding disorder (symptoms of hoarding disorder as part of the OCD diagnosis are allowed, but a primary diagnosis of hoarding disorder is excluded); a current diagnosis of Tourette's disorder is also excluded; 5. Any eating disorder within the last 12 months; 6. Acute suicidality or suicide attempt or self-injurious behavior in the last 6 months; 7. History of psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive Therapy (ECT). 8. Transcranial Magnetic Stimulation (TMS) is prohibited within 3 months prior to screening and during the study. 9. Participants who may have received a non-biological investigational agent in any clinical trial within 30 days, or a biological agent within 90 days prior to screening are excluded. 10. Creatinine ≥ 2 mg/dL. 11. Course of treatment for participants with localized cancers (without metastatic spread) is 5 years prior to screening. 12. QTcF (Fridericia) interval ≥ 470 msec during the screening or baseline period or uncontrolled arrhythmia or frequent premature ventricular contraction (PVCs) (\> 5/minute) or Mobitz Type II second or third degree atrioventricular (AV) block or left bundle branch block, or right bundle branch block with a QRS duration ≥ 150 msec or intraventricular conduction defect with a QRS duration ≥150 msec or evidence of acute or sub-acute myocardial infarction or ischemia and added or other electrocardiogram findings that, in the investigator's opinion, would preclude participation in the study. 13. Previous treatment with riluzole

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • AMR-Baber Research, Inc

    Naperville, Illinois, 60563, United States

  • ActivMed Practices and Research, Inc.

    Portsmouth, New Hampshire, 03801, United States

  • Artemis Institute for Clinical Research

    San Diego, California, 92103, United States

  • Artemis Institute for Clinical Research

    San Marcos, California, 92078, United States

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Bio Behavioral Institute

    Great Neck, New York, 11021, United States

  • Boston Clinical Trials

    Boston, Massachusetts, 02131, United States

  • CalNeuro Research Group

    Los Angeles, California, 90024, United States

  • Center for Emotional Fitness

    Cherry Hill, New Jersey, 08028, United States

  • Chicago Research Center

    Chicago, Illinois, 60634, United States

  • Clinical Neuroscience Solutions, Inc

    Jacksonville, Florida, 32256, United States

  • Clinical Neuroscience Solutions, Inc

    Orlando, Florida, 32801, United States

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee, 38119, United States

  • Collaborative Neuroscience Network, LLC

    Garden Grove, California, 92845, United States

  • Comprehensive Psychiatric Care

    Norwich, Connecticut, 06360, United States

  • Desert Valley Research

    Rancho Mirage, California, 92270, United States

  • Finger Lakes Clinical Research

    Rochester, New York, 14618, United States

  • FutureSearch Trials of Dallas, LP

    Dallas, Texas, 75231, United States

  • Galiz Research

    Hialeah, Florida, 33016, United States

  • Gulfcoast Clinical Research Center

    Fort Myers, Florida, 33912, United States

  • Harmony Clinical Research

    North Miami Beach, Florida, 33162, United States

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67207, United States

  • InSite Clinical Research

    DeSoto, Texas, 75115, United States

  • Institute of Living / Hartford Hospital

    Hartford, Connecticut, 06106, United States

  • Integrative Clinical Trials LLC

    Brooklyn, New York, 11229, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • McLean Hospital

    Belmont, Massachusetts, 02478, United States

  • Medical Research Group of Central Florida

    Orange City, Florida, 32763, United States

  • Metropolitan Neuro Behavioral Institute

    Chandler, Arizona, 85226, United States

  • Michigan Clinical Research PC

    Ann Arbor, Michigan, 48105, United States

  • Midwest Clinical Research Center

    Dayton, Ohio, 45417, United States

  • Mountain View Clinical Research, Inc.

    Denver, Colorado, 80209, United States

  • NRC Research Institute

    Orange, California, 92868, United States

  • New Hope Clinical Research

    Charlotte, North Carolina, 28211, United States

  • New Horizons Clinical Research

    Cincinnati, Ohio, 45242, United States

  • New York State Psychiatric Institute

    New York, New York, 10032, United States

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007, United States

  • Pacific Clinical Research Medical Group

    Upland, California, 91786, United States

  • Pacific Research Partners, LLC

    Oakland, California, 94607, United States

  • Pharmasite Research, Inc.

    Pikesville, Maryland, 21208, United States

  • Phoenix Medical Research, Inc.

    Prairie Village, Kansas, 66208, United States

  • Precise Research Centers

    Flowood, Mississippi, 39232, United States

  • Preferred Research Partners, Inc.

    Little Rock, Arkansas, 72211, United States

  • Psychiatric Alliance of the Blue Ridge, Inc.

    Charlottesville, Virginia, 22903, United States

  • Richmond Behavioral Associates

    Staten Island, New York, 10312, United States

  • SIH Research, Inc

    Kissimmee, Florida, 34741, United States

  • Stanford University, Department of Psychiatry and Behavioral Sciences

    Stanford, California, 94305-5717, United States

  • Suburban Research Associates

    Media, Pennsylvania, 19063, United States

  • Summit Research Network (Oregon) Inc.

    Portland, Oregon, 97210, United States

  • Synergy Research San Diego

    Lemon Grove, California, 91945, United States

  • University of California San Diego

    La Jolla, California, 92037, United States

  • University of Chicago Department of Psychiatry & Behavioral Neuroscience

    Chicago, Illinois, 60637, United States

  • University of Florida Department of Psychiatry

    Gainesville, Florida, 32606, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Yale University

    New Haven, Connecticut, 06519, United States

  • iResearch Atlanta, LLC

    Decatur, Georgia, 30030, United States

  • iResearch Savannah

    Savannah, Georgia, 31405, United States

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Other studies related to the condition(s) this trial covers.