Riluzole Augmentation in Treatment-refractory Obsessive-compulsive Disorder
Condition: Obsessive-compulsive Disorder; Ocd
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Intervention: riluzole; placebo
Intervention description: 50 mg PO bid, 12 weeks; placebo, 1 capsule PO bid, 12 weeks
Intervention MeSH terms: Riluzole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: obsessive-compulsive disorder; OCD; glutamate; riluzole; augmentation; treatment

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) diagnosis of OCD,
             confirmed by Structured Clinical Interview for DSM-IV (SCID-IV); symptoms of at least
             1 year duration

          -  moderate to severe OCD symptoms as measured by a score on the Yale-Brown
             Obsessive-Compulsive Scale (Y-BOCS) of 16 or greater

          -  documented failure of an adequate trial of a selective serotonin reuptake inhibitor
             (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