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Sponsored by: |
Massachusetts General Hospital |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00592358 |
This will be an 8-week open-label trial, using daily doses of paliperidone (Invega) in the treatment of children and adolescents who meet DSM-IV criteria of Bipolar I, Bipolar II, or Bipolar Spectrum Disorder. Specific hypotheses are as follows:
Hypothesis 1: Bipolar Disorder symptomatology in children and adolescents with DSM-IV Bipolar I, Bipolar II, or Bipolar Spectrum Disorder will be responsive to Invega treatment.
Hypothesis 2: Invega -associated improvement in bipolar disorder symptomatology in children and adolescents will translate into improved functional capacities (neuropsychological, social, and occupational), as well as an increased quality of life throughout treatment.
Hypothesis 2: Invega treatment will be safe and well tolerated as reflected by a low drop out rate and absence of major side effects.
Condition | Intervention | Phase |
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Pediatric Bipolar Disorder |
Drug: paliperidone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | Open-Label Study of Invega for the Treatment of Mania in Children and Adolescents Ages 6-17 With Bipolar I, Bipolar II, and Bipolar Spectrum Disorder |
Estimated Enrollment: | 40 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: paliperidone
tablet, 3mgQAM - 6mgQAM, taken daily for 8 weeks
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Invega (paliperidone), a second generation antipsychotic (SGA), is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives.
Invega is approved by the FDA for the treatment of schizophrenia in adults. Initial data suggest a promising role for Invega in the treatment of bipolar disorder with minimal adverse events of weight gain. We propose to study the safety and efficacy of Invega therapy in children and adolescents with Bipolar I, Bipolar II, and Bipolar Spectrum Disorder. The study results will be used to generate hypotheses for a larger, randomized, controlled clinical trial with explicit hypotheses and sufficient statistical power.
The proposed study includes 1) use of a 8-week design to document the response rate, 2) assessment of the impact of Invega on functional capacities (quality of life, psychosocial function) and cognition, and 3) careful assessment of safety and tolerability.
Ages Eligible for Study: | 6 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects with the diagnosis of Bipolar or Bipolar Spectrum Disorder and currently displaying manic, hypomanic, or mixed symptoms (with or without
psychotic features), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview. Bipolar Spectrum Disorder (or sub- threshold bipolar disorder) is operationalized as having severe mood disturbance, which meets DSM-IV Criteria A for bipolar disorder but display fewer elements in Criteria B (only require 2 items for elation category and 3 for irritability).
Subjects and their legal representative must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the
protocol.
Exclusion Criteria:
Contact: Meghan Kotarski, BS | 617-503-1051 | mkotarski@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Cambridge, Massachusetts, United States, 02138 |
Principal Investigator: | Janet Wozniak, MD | MGH |
Responsible Party: | MGH ( Janet Wozniak, MD ) |
Study ID Numbers: | 2007-P-001525 |
Study First Received: | December 28, 2007 |
Last Updated: | January 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00592358 History of Changes |
Health Authority: | United States: Institutional Review Board |
bipolar disorder children adolescents Invega |
Affective Disorders, Psychotic Tranquilizing Agents Mental Disorders Bipolar Disorder Psychotropic Drugs Risperidone |
Mood Disorders Central Nervous System Depressants 9-hydroxy-risperidone Psychotic Disorders Antipsychotic Agents |
Disease Tranquilizing Agents Bipolar Disorder Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants 9-hydroxy-risperidone Antipsychotic Agents |
Pharmacologic Actions Affective Disorders, Psychotic Pathologic Processes Mental Disorders Therapeutic Uses Mood Disorders Central Nervous System Agents |