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: January 13, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Obsessive-compulsive Disorder
Ocd
Drug: riluzole
Drug: placebo
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: September 2006
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: riluzole
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.
Drug: placebo
placebo, 1 capsule PO bid, 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00523718

Locations
United States, Connecticut
Yale OCD Research Clinic
New Haven, Connecticut, United States, 06508
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Christopher J Pittenger, MD, Ph.D. Yale University
  More Information

Additional Information:
Publications:
Responsible Party: Christopher Pittenger, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT00523718     History of Changes
Other Study ID Numbers: YOCD-1
Study First Received: August 29, 2007
Last Updated: January 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
obsessive-compulsive disorder
OCD
glutamate
riluzole
augmentation
treatment

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders
Riluzole
Serotonin Uptake Inhibitors
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on April 16, 2014