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. 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Double-blind Study of Riluzole Augmentation in Serotonin Reuptake Inhibitor-refractory Obsessive-compulsive Disorder and Depression|
- Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- Hamilton Depression Inventory (HAM-D) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- Hamilton Anxiety Inventory (HAM-A) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- Clinical Global Impression (CGI) - Severity of Illness item [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2006|
|Study Completion Date:||August 2015|
|Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment
50 mg PO bid, 12 weeks
Other Name: Rilutek (Sanofi-Aventis)
Placebo Comparator: placebo
Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.
placebo, 1 capsule PO bid, 12 weeks
Please refer to this study by its ClinicalTrials.gov identifier: NCT00523718
|United States, Connecticut|
|Yale OCD Research Clinic|
|New Haven, Connecticut, United States, 06508|
|Principal Investigator:||Christopher J Pittenger, MD, Ph.D.||Yale University|