Riluzole to Treat Child and Adolescent Obsessive-Compulsive Disorder With or Without Autism Spectrum Disorders
Completed · Phase 2 · Has a placebo group
Conditions studied: Obsessive-Compulsive Disorder, Autism Spectrum Disorder, Autism, Asperger Disorder, Developmental Disorder
In brief
This study will examine the effectiveness of riluzole for treating Obsessive-Compulsive Disorder in Youth, Including those with Autism Spectrum Disorders.
Key facts
- Study ID
- NCT00251303
- Run by
- National Institute of Mental Health (NIMH)
- People needed
- 78
- Starts
- 2005-08-01
- Expected to finish
- 2012-02-01
- Last updated by the study team
- 2014-07-15
Who can join
Age: 7 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Subjects will be excluded from the study for any of the following reasons:
- 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.
- 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.
- Disabling Tic Disorder requiring contraindicated medicines.
- Male or female subjects who are unwilling to use effective contraception, or female subjects who are pregnant or nursing.
- Serious unstable illnesses, including gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
- 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.
- Documented history of hypersensitivity or intolerance to riluzole.
- DSM-IV Substance Abuse Disorder within the past 90 days or Substance Dependence Disorder within the past 5 years, or any use of tobacco.
- Taking contraindicated drugs.
- Unable to swallow capsules.
- In addition, patients will not receive cognitive-behavior therapy during the period of the study.
- Abnormal EEG unless evaluated by a neurologist and approved by that specialist for this protocol.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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