Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00523718 · ClinicalTrials.gov registry record · Phase 2

Riluzole Augmentation in Treatment-refractory Obsessive-compulsive Disorder

A Phase 2 study, sponsored by Yale University.

Completed
Registry status
Phase 2
Development phase
40
Enrollment target

NCT00523718 is a Phase 2 study that has completed, run by Yale University. The registered enrollment target is 40 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00523718, a Phase 2 study, has completed, sponsored by Yale University.

COMPLETED
Registry status
Phase 2
Development phase
40 participants
Enrollment target

Study Summary

Obsessive-compulsive disorder (OCD) affects 2-3% of the population and leads to a great deal of suffering. Many patients benefit from established treatments, the mainstay of which are cognitive behavioral therapy and a group of antidepressant medications known as serotonin reuptake inhibitors. However, 20-30% of patients get minimal benefit from these established therapeutic strategies. New avenues of treatment are urgently needed. Existing medications for obsessive-compulsive disorder affect the neurotransmitters serotonin or dopamine; but increasing evidence suggests that functional disruptions of a different neurotransmitter, glutamate, may contribute to some cases of OCD. The investigators are therefore interested in using medications that target glutamate as novel treatment options for those OCD patients who do not benefit from established treatments. One such medication is the drug riluzole, which is FDA approved for amyotrophic lateral sclerosis (ALS), or Lou Gehrig's disease, but may be of benefit to patients with psychiatric disorders due to its ability to moderate excessive glutamate. In preliminary studies, in which the investigators treated patients with riluzole (in addition to their established pharmacological regimen) in an open-label fashion (that is, without a placebo-treated control group), the investigators have found about 40-50% of patients to substantially improve over 2-3 months. While immensely promising, these preliminary studies do not prove riluzole is truly a new beneficial medication for the treatment of OCD; a more rigorous placebo-controlled trial is needed for that purpose. The investigators are therefore now recruiting patients to participate in a double-blind, placebo-controlled trial of riluzole, added to whatever other OCD medications they are taking.

Interventions

  • DRUG placebo
  • DRUG riluzole

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2006-09
Est. Completion 2015-08
Phase Phase 2

Sponsor

Yale University

1,492 total trials

What the Registry Record Tells You About NCT00523718

The ClinicalTrials.gov registry entry for NCT00523718 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT00523718 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00523718 about?

NCT00523718 is a clinical study titled "Riluzole Augmentation in Treatment-refractory Obsessive-compulsive Disorder". Obsessive-compulsive disorder (OCD) affects 2-3% of the population and leads to a great deal of suffering. Many patients benefit from established treatments, the mainstay of which are cognitive behavioral therapy and a group of antidepressant medications known as serotonin reuptake inhibitors. Howev...

What is the current status of trial NCT00523718?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2006-09. Estimated completion is 2015-08.

What interventions are being tested in trial NCT00523718?

The interventions under investigation include: placebo (DRUG), riluzole (DRUG).

Who is sponsoring clinical trial NCT00523718?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.