跳至主要内容
临床试验/NCT00251303
NCT00251303已完成2 期

An Investigation of the Efficacy in Childhood Obsessive-Compulsive Disorder of Riluzole: An Antiglutamatergic Agent

National Institute of Mental Health (NIMH)1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2005年8月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
78
试验地点
1
主要终点
Children's Yale-Brown Obsessive-Compulsive Scale Scores (CY-BOCS)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
7 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

riluzole

Experimental

Active drug put into 10-mg capsule form,,prepared by Clinical Center Pharmacy. Dose up to 120 mg daily, divided. Brand name Rilutek.

干预措施: Riluzole (Drug)

placebo

Placebo Comparator

Placebo Capsules designed to mimic active drug capsules

干预措施: Placebo (Drug)

结局指标

主要结局

Children's Yale-Brown Obsessive-Compulsive Scale Scores (CY-BOCS)

时间窗: 12 weeks

CY-BOCS is a 0-40 point scale of obsessive-compulsive symptom severity, higher number indicates more severe obsessive-compulsive symptoms. Comparison of 12 weeks scores for placebo and riluzole groups.

Much/Very Much Improved on Clinical Global Impressions - Improvement Score (CGI-I)

时间窗: 12 weeks

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Principal Investigator
主要研究者

Susan Swedo, M.D.

Chief, Pediatrics and Developmental Neuroscience Branch

National Institutes of Health Clinical Center (CC)

研究点 (1)

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