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Aripiprazole for the Treatment of Mania in Children and Adolescents With Bipolar Disorder

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00181779
First received: September 13, 2005
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

This is an open-labeled study of Aripiprazole, testing its efficacy in the treatment of mania in children and adolescents with Bipolar I, Bipolar II and Bipolar Spectrum Disorder over 8 weeks. This is an exploratory, pilot study, seeking to determine whether Aripiprazole is efficacious and well tolerated in the treatment of youth with pediatric bipolar 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.


Condition Intervention Phase
Bipolar Disorder
Mania
Drug: aripiprazole (Abilify)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Pilot Study of Aripiprazole for the Treatment of Mania in Children and Adolescents With Bipolar I, Bipolar II, and Bipolar Spectrum Disorder

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Scores on the Young Mania Rating Scales

Estimated Enrollment: 20
Study Start Date: February 2003
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Initial clinical evidence suggests that atypical neuroleptics may play a unique therapeutic role in the management of pediatric bipolar disorder. Aripiprazole is a novel neuroleptic recently approved by the FDA for the treatment of schizophrenia, and it has a unique pharmacological profile believed to be fundamentally different from other available antipsychotics. Many previous studies have reported increased efficacy of Aripiprazole compared to placebo. Unfortunately, Aripiprazole has not been investigated in children and adolescents, and as such, safety and efficacy has not been established for these populations.

This is an exploratory, pilot study, seeking to determine whether Aripiprazole is efficacious and well tolerated in the treatment of youth with pediatric bipolar and bipolar spectrum disorder. The study results, gathered from an 8 week open-label treatment period and subsequent 10 month extension period, will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.

  Eligibility

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

Inclusion Criteria:

  1. Male or female patients, 6-17 years of age.
  2. Patient and parent 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.
  3. Patients and their legal representative must be considered reliable.
  4. Each patient and his/her authorized legal representative must understand the nature of the study. The patient's authorized legal representative must sign an informed consent document and the patient must sign an informed assent document.
  5. Patient must have a diagnosis of bipolar I or bipolar II disorder and currently display an acute manic, hypomanic, or mixed episode (with or without psychotic features) according to the DSM-IV based on clinical assessment and confirmed by structured diagnostic interview (Kidd Schedule of Affective Disorders). Eligible will also be children with bipolar spectrum disorder (or sub-threshold bipolar disorder) operationalized as having severe mood disturbance, which meets DSM-IV Criteria A for bipolar disorder but meet fewer elements in criteria B (only require 2 items for elation category and 3 for irritability).
  6. Patients must have an initial score on the Y-MRS total score of at least 15.
  7. Patient must be able to participate in mandatory blood draws.
  8. Patient must be able to swallow pills.

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, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
  3. Uncorrected hypothyroidism or hyperthyroidism.
  4. History of severe allergies or multiple adverse drug reactions.
  5. Non-febrile seizures without a clear and resolved etiology.
  6. Leukopenia or history of leukopenia without a clear and resolved etiology.
  7. DSM-IV substance (except nicotine or caffeine) dependence within past 6 months.
  8. Judged clinically to be at serious suicidal risk.
  9. Any other concomitant medication with primarily central nervous system activity other than specified in Concomitant Medication portion of the protocol.
  10. History of intolerance or a non-responder to Aripiprazole as determined by the clinician.
  11. Treatment with nonreversible monoamine oxidase inhibitors within 2 weeks prior to Visit 2.
  12. Current diagnosis of schizophrenia.
  13. For concomitant stimulant therapy used to treat ADHD, patients must have been on a stable dose of the medication for 1 month prior to randomization.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00181779

Locations
United States, Massachusetts
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Massachusetts General Hospital
Bristol-Myers Squibb
Investigators
Principal Investigator: Joseph Biederman, MD Massachusetts General Hospital
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joseph Biederman, MD, Chief, Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD; Professor of Psychiatry, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00181779     History of Changes
Other Study ID Numbers: 2003-P-000153
Study First Received: September 13, 2005
Last Updated: October 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
mania
Abilify
children
bipolar disorder

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes
Aripiprazole
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014