跳至主要内容
临床试验/NCT01019967
NCT01019967终止不适用

A Magnetic Resonance Spectroscopic Examination of Children and Adolescents Taking Riluzole for Obsessive-Compulsive Disorder

National Institute of Mental Health (NIMH)1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2009年11月17日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
17
试验地点
1
主要终点
Change in brain glutamate after adding riluzole vs. placebo

研究概览

简要总结

Background:

  • Obsessive-compulsive disorder (OCD) is a common childhood disorder that often does not respond to standard treatments. Researchers are exploring the role that a brain chemical called glutamate plays in symptoms of OCD, and are testing a drug called riluzole that reduces glutamate to see if changing the levels of glutamate in the brain will help treat the disorder.
  • Researchers are interested in using magnetic resonance spectroscopy (MRS), a type of magnetic imaging, to take pictures of various chemicals in the brain. MRS images will be used to detect changes in brain levels of glutamate in children taking riluzole.

Objectives:

  • To use magnetic resonance spectroscopy to study the levels of glutamate in the brains of children and adolescents who have been taking riluzole.

Eligibility:

  • Children and adolescents ages 7 to 17 who are enrolled in the current NIMH riluzole trial protocol (05-M-0225), who are able to lie still in the scanner for about an hour each time, and who are willing to have up to three MRS scans.

Design:

  • Researchers will study some children/adolescents before they begin to take the study medication riluzole or placebo these children will have an MRS scan before starting the study medication. The scan will take about an hour.
  • About 2 weeks after reaching the full dose on the study medication, participants will have a second hour-long MRS scan. Participants will have a third MRS scan after being on the study medication for 12 weeks.
  • Some children who have already completed 12 weeks on riluzole or placebo, and are now taking riluzole, will have only one MRS scan.

详细描述

Objective

This study uses magnetic resonance spectroscopy (MRS) to measure the neurotransmitter glutamate in the anterior cingulate cortex (and, if tolerated, the left caudate nucleus and possibly the thalamus) in children and adolescents.

Study Population

All of the subjects will be participants in an ongoing double-blind placebo-controlled trial (05-M-0225) of a glutamate antagonist, the drug riluzole, for Obsessive-Compulsive Disorder (OCD). The subjects are male and female children and adolescents, ages 7-17 years. They will all have met criteria for clinically significant OCD and will have failed to benefit from standard-of-care treatments or have been unable to tolerate the treatments. Some of the subjects will also have a diagnosis on the autism spectrum.

Design

研究设计

研究类型
Observational
时间视角
Prospective

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

结局指标

主要结局

Change in brain glutamate after adding riluzole vs. placebo

次要结局

  • Correlation between brain glutamate activity and riluzole level

研究者

研究点 (1)

Loading locations...

相似试验