Riluzole to Treat Child and Adolescent Obsessive-Compulsive Disorder With or Without Autism Spectrum Disorders
This study will examine the effectiveness of riluzole for treating Obsessive-Compulsive Disorder in Youth, Including those with Autism Spectrum Disorders.
Autism Spectrum Disorder
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||An Investigation of the Efficacy in Childhood Obsessive-Compulsive Disorder of Riluzole: An Antiglutamatergic Agent|
- Reduction of 30% or more in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) and Repetitive Behavior Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Much/Very much improved on Clinical Global Impressions - Improvement score (CGI-I) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||August 2005|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
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. Additionally, these medicines have been associated with a slight but significant increase in onset of suicidal thoughts among adolescents being treated for depression or OCD. 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. Further, in a recent report on a multi-site study of childhood OCD, CBT alone at one site fared little better than placebo.
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. It is currently being studied in adults with OCD, and this two-stage study will evaluate the possibility that riluzole will help children with OCD, Riluzole has been approved by the Food and Drug Administration (FDA) for treatment of amyotrophic lateral sclerosis (ALS), and is currently under investigation at the NIMH for treatment of depression.
The first stage of this investigation has been completed. Six children with OCD, ages 7 to 17 years, received riluzole as part of a study that evaluated the drug's safety and estimated the appropriate dose of riluzole Riluzole was added to the children's current medication regimen or was used as sole agent. The second stage of the investigation will enroll up to 60 additional subjects with OCD including some who have both autistic spectrum disorder (ASD) and OCD. The subjects will participate in a double-blind, placebo-controlled12-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.
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Jennifer A Cameron, Ph.D.||National Institute of Mental Health (NIMH)|