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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00805493 |
Objective: To test the efficacy of riluzole in youth with bipolar disorder
Study population: Youth, ages 9-17, with DSM-IV bipolar disorder, who have failed to respond to two adequate trials of medication, one with an atypical antipsychotic medication, and the second with either a mood stabilizing medication or a second atypical antipsychotic medication.
Design: Medication withdrawal, followed by a 15-day dose stabilization phase and a 6-week double-blind, placebo-controlled treatment trial. The first two phases will be completed as inpatients or in day treatment, while the third phase can be completed either in those settings or as an outpatient. Individuals who received placebo will be offered an 8-week open trial of riluzole followed by an additional 4 weeks if they respond, while those who received riluzole in the placebo-controlled trial and wish to continue it will receive 4 weeks of open treatment. Thus, all patients will have the opportunity to receive a total of 12 weeks of riluzole treatment.
Outcome measures: Clinical rating scales, including the Pediatric Anxiety Rating Scale and the Clinical Global Improvement Scale
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Condition | Intervention | Phase |
---|---|---|
Bipolar Disorder Anxiety Disorders Bipolar Affective Disorder Bipolar Depression |
Drug: Riluzole |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double-Blind Placebo-Controlled Trial of Riluzole in Pediatric Bipolar Disorder |
Estimated Enrollment: | 80 |
Study Start Date: | November 2008 |
Objective: To test the efficacy of riluzole in youth with bipolar disorder
Study population: Youth, ages 9-17, with DSM-IV bipolar disorder, who have failed to respond to two adequate trials of medication, one with an atypical antipsychotic medication, and the second with either a mood stabilizing medication or a second atypical antipsychotic medication.
Design: Medication withdrawal, followed by a 15-day dose stabilization phase and a 6-week double-blind, placebo-controlled treatment trial. The first two phases will be completed as inpatients or in day treatment, while the third phase can be completed either in those settings or as an outpatient. Individuals who received placebo will be offered an 8-week open trial of riluzole followed by an additional 4 weeks if they respond, while those who received riluzole in the placebo-controlled trial and wish to continue it will receive 4 weeks of open treatment. Thus, all patients will have the opportunity to receive a total of 12 weeks of riluzole treatment.
Outcome measures: Clinical rating scales, including the Pediatric Anxiety Rating Scale and the Clinical Global Improvement Scale
Ages Eligible for Study: | 9 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Previous treatment failure as defined by:
The child is failing his/her current treatment as defined by (all 3 met):
EXCLUSION CRITERIA:
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Responsible Party: | National Institutes of Health ( Ellen Leibenluft, M.D./National Institute of Mental Health ) |
Study ID Numbers: | 090042, 09-M-0042 |
Study First Received: | December 6, 2008 |
Last Updated: | January 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00805493 |
Health Authority: | United States: Federal Government |
Mania Bipolar Bipolar Disorder Bipolar Manic-Depressive Illness |
Bipolar Mood Disorder Bipolar Disorder Bipolar Mood Disorder Bipolar Manic-Depressive Illness |
Riluzole Excitatory Amino Acids Affective Disorders, Psychotic Depression Anxiety Disorders Mental Disorders |
Bipolar Disorder Mood Disorders Psychotic Disorders Depressive Disorder Behavioral Symptoms |
Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Excitatory Amino Acid Agents Neuroprotective Agents Protective Agents |
Pharmacologic Actions Pathologic Processes Therapeutic Uses Central Nervous System Agents Anticonvulsants Excitatory Amino Acid Antagonists |