Riluzole to Treat Child and Adolescent Obsessive-Compulsive Disorder With or Without Autism Spectrum Disorders
Condition: Obsessive-Compulsive Disorder; Autism Spectrum Disorder; Autism; Asperger Disorder; Developmental Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Developmental Disabilities; Asperger Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine the effectiveness of riluzole for treating Obsessive-Compulsive
      Disorder in Youth, Including those with Autism Spectrum Disorders.
    

Detailed description: 
      Obsessive-Compulsive Disorder (OCD) is a chronic psychiatric disorder characterized by the
      presence of intrusive and unwanted obsessional thoughts and images and of compulsive
      behaviors. Its presentation during childhood is similar to that seen in adulthood, except
      that children sometimes lack insight into the senselessness of the thoughts and behaviors.
      Although many patients benefit from treatment with selective serotonin reuptake inhibitors
      (SSRIs), a significant proportion have limited or no response to these medications. Cognitive
      behavioral therapy (CBT) may also be effective for OCD, alone or in combination with SSRIs,
      but there is a shortage of qualified therapists, and many patients and families cannot
      participate effectively in the therapy.

      There is a pressing need, then, for the development of alternative, novel treatments for
      pediatric OCD. Neuropsychological and neuroimaging data suggest that OCD may arise from
      dysfunction of orbitofronto-striato-thalamocortical circuitry. Glutamate plays a crucial role
      in the regulation of excitatory activity within this circuit and may be involved in the
      etiopathogenesis of OCD. If so, then agents which reduce glutamatergic neurotransmission may
      provide unique antiobsessional benefits. Riluzole is a medication that reduces glutamatergic
      activity. A small open-label trial suggested that it might reduce OCD severity among children
      and adolescents.

      The investigation will enroll up to 80 pediatric subjects with OCD including some who have
      both autistic spectrum disorder (ASD) and OCD. The subjects will participate in a
      double-blind, placebo-controlled 12-week trial of riluzole as a sole agent or as an
      augmentation to their currently inadequate therapy. Following the double-blind portion of the
      trial, subjects may receive three months of open-label treatment with riluzole, if it is
      clinically indicated. All subjects will be followed at regular intervals until one year from
      baseline.
    

Intervention name(s): Riluzole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active drug put into 10-mg capsules by NIH Clinical Center Pharmacy. Matched placebo capsules were also prepared by NIH Clinical Center Pharmacy. Dose up to 120 mg daily, divided into bid dosages.; Capsules matched active drug in appearance.
Other intervention name(s): Rilutek
Intervention MeSH terms: Riluzole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Clinical Trial; Glutamate Antagonist; Pediatrics; Basal Ganglia; Neuropsychological; Obsessive Compulsive Disorder; OCD; Riluzole; Rilutek