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Invega for the Treatment of Mania in Children and Adolescents Ages 6-17 With Bipolar Disorder
This study is currently recruiting participants.
Verified by Massachusetts General Hospital, December 2007
First Received: December 28, 2007   Last Updated: January 11, 2008   History of Changes
Sponsored by: Massachusetts General Hospital
Information provided by: Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00592358
  Purpose

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
Pediatric Bipolar Disorder
Drug: paliperidone
Phase IV

MedlinePlus related topics: Bipolar Disorder
Drug Information available for: Paliperidone
U.S. FDA Resources
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

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • symptom reduction using Young Mania Rating Scale (YMRS) [ Time Frame: weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • symptom reduction using DSM-IV Mania Symptoms Checklist [ Time Frame: weekly ] [ Designated as safety issue: No ]

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
1: Experimental Drug: paliperidone
tablet, 3mgQAM - 6mgQAM, taken daily for 8 weeks

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female outpatients 6-17 years of age (inclusive).
  2. 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).

  3. Subjects must score ≥ 20 on the YMRS.
  4. 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.

  5. Subjects and their legal representative must be considered reliable reporters.
  6. Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document and the subject must sign an informed assent document (if ≥ 7 years old).
  7. Subject must be able to participate in mandatory blood draws.
  8. Subject must be able to swallow pills.
  9. Subjects with comorbid ODD, CD, OCD, PDD, anxiety and depressive disorders will be allowed to participate in the study provided they do not meet for any of the exclusionary criteria.
  10. For concomitant therapy used to treat ADHD, subjects must have been on a stable dose of the medication for 1 month prior to study enrollment. The dose of the ADHD therapy will not change throughout the duration of the study.

Exclusion Criteria:

  1. Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
  2. Serious, unstable illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
  3. Uncorrected hypothyroidism or hyperthyroidism.
  4. Non-febrile seizures without a clear and resolved etiology.
  5. DSM-IV substance (except nicotine or caffeine) dependence within past 6 months.
  6. Judged clinically to be at serious suicidal risk.
  7. Any other concomitant medication with primary central nervous system activity other than specified in the Concomitant Medication portion of the protocol.
  8. Current diagnosis of schizophrenia.
  9. Mental retardation (IQ < 75).
  10. Pregnant or nursing females.
  11. Known hypersensitivity to Invega® or similar formulations (paliperidone, risperidone).
  12. A non-responder or history of intolerance to Invega®, after treatment at adequate doses as determined by the clinician.
  13. Severe allergies or multiple adverse drug reactions.
  14. Subjects with a hematological disorder.
  15. Subjects with diabetes.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00592358

Contacts
Contact: Meghan Kotarski, BS 617-503-1051 mkotarski@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Janet Wozniak, MD MGH
  More Information

Additional Information:
No publications provided

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

Keywords provided by Massachusetts General Hospital:
bipolar disorder
children
adolescents
Invega

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009