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Double-Blind Placebo-Controlled Trial of Riluzole in Pediatric Bipolar Disorder
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), November 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00805493
  Purpose

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

...


Condition Intervention Phase
Bipolar Disorder
Anxiety Disorders
Bipolar Affective Disorder
Bipolar Depression
Drug: Riluzole
Phase II

MedlinePlus related topics: Anxiety Bipolar Disorder Depression
Drug Information available for: Riluzole
U.S. FDA Resources
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

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Pediatric Anxiety Rating Scale; Clinical Global Impression--Improvement [ Time Frame: 8 week trial with the study running for about 4 years. ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: November 2008
Intervention Details:
    Drug: Riluzole
    N/A
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   9 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Boys and girls
  • Ages 9-17 years of age; 17 year-old participants who reach their 18th birthday while in the study will be allowed to continue and complete research and clinical care procedures under this protocol.
  • Meet DSM-IV criteria for bipolar disorder.
  • The child must have a primary caregiver who can accompany him or her on trips to NIMH, provide reliable history and information, and complete rating scales.
  • Patients must have a psychiatrist who provides clinical care for their BPD.
  • All youth accepted into the study must be able to complete self-rating forms and to cooperate with other study procedures.
  • Previous treatment failure as defined by:

    1. Failure to respond to an adequate trial (adequate dose for at least two weeks) of a mood stabilizer (either lithium or divalproex) plus an adequate trial (sufficient dose for an adequate duration) of an atypical antipsychotic (such as risperidone, olanzapine, quetiapine, ziprasidone, or aripiprazole) or
    2. Failure to respond to an adequate trial (sufficient dose for an adequate duration) of two atypical antipsychotics (such as risperidone, olanzapine, quetiapine, ziprasidone, or aripiprazole) or
    3. Evidence of intolerance (severe weight gain or other side effects) of a mood stabilizer or atypical antipsychotic agent.
  • The child is failing his/her current treatment as defined by (all 3 met):

    1. The child's current CGAS score must be less than 60.
    2. The child's current psychiatrist must agree that the child's response to his/her current treatment is no more than minimal or there are drug side effects that are proving problematic. According to this criterion, it would be clinically appropriate to change the child's current treatment.
    3. On the basis of record review and interviews with child and parent, the research team agrees that the child's response to his/her current treatment is no more than minimal.
  • Subject has a PARS score of greater than or equal to 10, derived from the total of the following individual items: 3 (overall severity of anxious feelings), 5 (overall avoidance), 6 (interference with family), and 7 (interference outside of the home). In addition, patients must score 3 or higher (i.e., in the clinical range) on at least one of the four items noted above.

EXCLUSION CRITERIA:

  • I.Q. less than 70
  • Autistic disorder or severe pervasive developmental disorder; psychosis that interferes with the child's capacity to understand and comply with study procedures;
  • Unstable medical illness (e.g. severe asthma) or contraindication to riluzole
  • Medical illness that could cause the symptoms of bipolar illness (e.g. multiple sclerosis, thyroid disease);
  • Pregnancy
  • 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 two-fold elevation of serum transaminases (ALT/SGPT, AST/SGOT), gamma glutamate (GGT), or bilirubin.
  • Documented history of hypersensitivity or intolerance to riluzole.
  • Substance abuse within two months of study entry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00805493

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Publications:
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

Keywords provided by National Institutes of Health Clinical Center (CC):
Mania
Bipolar
Bipolar Disorder
Bipolar Manic-Depressive Illness
Bipolar Mood Disorder
Bipolar Disorder
Bipolar Mood Disorder
Bipolar Manic-Depressive Illness

Study placed in the following topic categories:
Riluzole
Excitatory Amino Acids
Affective Disorders, Psychotic
Depression
Anxiety Disorders
Mental Disorders
Bipolar Disorder
Mood Disorders
Psychotic Disorders
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 30, 2009