National Institute of Mental Health (NIMH)
|Information provided by:||National Institutes of Health Clinical Center (CC)|
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:||Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study|
|Official Title:||An Investigation of the Efficacy in Childhood Obsessive-Compulsive Disorder of Riluzole: An Antiglutamatergic Agent|
|Study Start Date:||August 2005|
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 (March and et al, 2004).
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. Studies in adults with OCD are already in progress. To evaluate the possibility of benefit in children, we propose to conduct a two-stage study of a novel pharmaceutical, riluzole, an agent that reduces glutamatergic effect via inhibition of its release and perhaps via other mechanisms. Riluzole is Food and Drug Administration (FDA)-approved for treatment of amyotrophic lateral sclerosis (ALS), and is currently under investigation at the NIMH for treatment of acute depression.
This proposal is for a 12-week, single-arm, open-label study that will evaluate safety and estimate dose in 6 children, ages 7 to 17 years, with a primary diagnosis of OCD, including those who previously have tried one or more psychopharmacologic agents with Food and Drug Administration (FDA) indication for childhood OCD but who have found that treatment ineffective or poorly tolerated. Riluzole will be added to current regimen or used as sole agent. Following this feasibility and dose-finding study, a second stage will enroll 30 additional subjects with OCD as well as 30 additional subjects who have both autistic spectrum disorder (ASD) and OCD. These 60 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. Patients will be followed at regular intervals until one year from baseline, for safety monitoring.
|Contact: Lorraine Lougee, L.C.S.W.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|