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Clinical trial, childhood bipolar disorder

Clinical trial, childhood bipolar disorder

Bipolar Research Studies

Clinical trial of riluzole in pediatric bipolar disorder

Date: Oct. 6, 2011

This study is testing the effectiveness of riluzole versus placebo for decreasing anxiety in children with pediatric bipolar disorder (BP). Children and youth with bipolar disorder display episodic elevated mood and associated symptoms of decreased need for sleep, increased goal-directed behavior, and increased self-esteem/grandiosity.

Children ages 9 to 17 with BP may be eligible to participate in this 12- to 15-week inpatient or outpatient study. This study has four phases. During Phase I, participants are gradually withdrawn from all current psychotropic medications. Phase II is a one-week medication-free period. During Phase III, which lasts two weeks, participants are randomly assigned to also receive either riluzole or placebo (a “sugar pill”). Phase IV lasts for 6 weeks. During this time, participants continue riluzole or placebo.

At the end of the study, those who received placebo have the opportunity to receive riluzole.

All procedures and medications associated with the research are provided at no cost to participants, and assistance with transportation and lodging expenses is available. Schooling will be provided while on the inpatient unit or in day treatment.

To find out if you qualify or for more information, please call (301) 496-8381 or email us at bipolarkids@mail.nih.gov.

National Institute of Mental Health
National Institutes of Health
Department of Health & Human Services
[The principal researcher is Ellen Leibenluft, M.D., Chief, Unit on Affective Disorders, NIMH Pediatrics and Developmental Neuropsychiatry Branch]