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Riluzole Augmentation in Treatment-refractory Obsessive-compulsive Disorder

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Christopher Pittenger, Yale University
ClinicalTrials.gov Identifier:
NCT00523718
First received: August 29, 2007
Last updated: July 23, 2014
Last verified: July 2014

August 29, 2007
July 23, 2014
September 2006
October 2014   (final data collection date for primary outcome measure)
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) [ Time Frame: 14 weeks ]
Complete list of historical versions of study NCT00523718 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Hamilton Depression Inventory (HAM-D) [ Time Frame: 14 weeks ]
  • Hamilton Anxiety Inventory (HAM-A) [ Time Frame: 14 weeks ]
  • Clinical Global Impression (CGI) - Severity of Illness item [ Time Frame: 14 weeks ]
Not Provided
Not Provided
 
Riluzole Augmentation in Treatment-refractory Obsessive-compulsive Disorder
A Double-blind Study of Riluzole Augmentation in Serotonin Reuptake Inhibitor-refractory Obsessive-compulsive Disorder and Depression

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Obsessive-compulsive Disorder
  • Ocd
  • Drug: riluzole
    50 mg PO bid, 12 weeks
    Other Name: Rilutek (Sanofi-Aventis)
  • Drug: placebo
    placebo, 1 capsule PO bid, 12 weeks
  • Experimental: riluzole
    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
    Intervention: Drug: riluzole
  • 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.
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
October 2014
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • DSM-IV diagnosis of OCD, confirmed by SCID-IV; symptoms of at least 1 year duration
  • moderate to severe OCD symptoms (Y-BOCS > 16)
  • documented failure of an adequate trial of an SSRI
  • agreement to engage in a reliable form of birth control (women only)

Exclusion Criteria:

  • primary diagnosis of a psychotic disorder
  • active substance abuse or dependence
  • unstable medical condition
  • prior exposure to riluzole
  • prior psychosurgery
  • pregnancy, breastfeeding, or intent to become pregnant during study
  • liver function tests (LFTs) elevated to more than 2x the upper limit of normal
  • evidence of active liver disease
  • seizure disorder
  • active suicidal ideation
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00523718
YOCD-1
No
Christopher Pittenger, Yale University
Yale University
Not Provided
Principal Investigator: Christopher J Pittenger, MD, Ph.D. Yale University
Yale University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP