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

Stopped early

Conditions studied: Childhood Obsessive-Compulsive Disorder, Autism Spectrum Disorders

In brief

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.

Key facts

Study ID

NCT01019967

Run by

National Institute of Mental Health (NIMH)

People needed

17

Starts

2009-11-17

Expected to finish

2012-09-20

Last updated by the study team

2017-10-06

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. Medicially 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.
• Female subjects who are pregnant, nursing, or unwilling to use effective contraception.
• 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.

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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