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
Intervention: Riluzole; Placebo
Intervention description: 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.
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: 78.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Clinical Trial; Glutamate Antagonist; Pediatrics; Basal Ganglia; Neuropsychological; Obsessive Compulsive Disorder; OCD; Riluzole; Rilutek

Summary:

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

Eligibility criteria:

        -  INCLUSION CRITERIA:

        Subjects may be included in the study only if they meet all of the following criteria:

          1. Male or female subjects, 7 to 17 years of age.

          2. Male and female subjects of childbearing potential must be using a medically accepted
             means of contraception or must remain abstinent.

          3. Each legal guardian must have a level of understanding sufficient to agree to all
             required tests and examinations. Each legal guardian must understand the nature of the
             study. Each legal guardian must consent to study protocol.

          4. Subjects must fulfill DSM-IV criteria for (OCD) and have a CY-BOCS score of greater
             than 20. In the double-blind phase, subjects enrolled in the combined OCD and ASD
             cohort must also meet DSM-IV criteria for Pervasive Developmental Disorder as well as
             OCD.

          5. Each subject already taking medicine must be taking usually effective doses of a
             medicine demonstrated to be effective in childhood OCD, must have been stable on that
             dose for at least six weeks, and must have no newly recognized or intolerable adverse
             effects from that medicine. Subjects who are currently not taking such a medication
             must have had adequate trial in the past of at least one medicine that has been shown
             to be effective for the symptoms of childhood OCD, and must have failed to see
             improvement or must have had intolerable adverse effects from the medicine.

          6. Subjects must be able to swallow capsules.

        EXCLUSION CRITERIA:

        Subjects will be excluded from the study for any of the following reasons:

          1. Presence of psychotic symptoms or lifetime history of schizophrenia, bipolar disorder,
             other psychotic disorder, or other serious unstable psychiatric illness. Medically
             unstable due to binging, purging, or starvation.

          2. Judged clinically to be at risk for suicide (suicidal ideation, severe depression, or
             other factors). Diagnosis of DSM-IV Major Depressive Disorder is not necessarily an
             exclusion criterion.

          3. Disabling Tic Disorder requiring contraindicated medicines.

          4. Male or female subjects who are unwilling to use effective contraception, or female
             subjects who are pregnant or nursing.

          5. Serious unstable illnesses, including gastroenterologic, respiratory, cardiovascular
             (including ischemic heart disease), endocrinologic, neurologic, immunologic, or
             hematologic disease.

          6. Renal or hepatic dysfunction that would interfere with excretion or metabolism of
             riluzole as evidenced by increase above upper limits of normal for BUN/creatinine, or
             more than two-fold elevation above upper limits of normal of serum transaminases
             (ALT/SGPT, AST/SGOT), gamma glutamate (GGT), or bilirubin.

          7. Documented history of hypersensitivity or intolerance to riluzole.

          8. DSM-IV Substance Abuse Disorder within the past 90 days or Substance Dependence
             Disorder within the past 5 years, or any use of tobacco.

          9. Taking contraindicated drugs.

         10. Unable to swallow capsules.

         11. In addition, patients will not receive cognitive-behavior therapy during the period of
             the study.

         12. Abnormal EEG unless evaluated by a neurologist and approved by that specialist for
             this protocol.