An Open-Label Trial of Aripiprazole in Children and Adolescents With Bipolar Disorder

This study has been completed.
Sponsor:
Collaborators:
Children's Hospital Medical Center, Cincinnati
Bristol-Myers Squibb
Information provided by (Responsible Party):
Robert Kowatch, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT00221416
First received: September 14, 2005
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

This is an investigator-initiated study whose primary aim is to determine the effectiveness of aripiprazole (Abilify®) in helping persons with symptoms of mania whose current medications do not completely control those symptoms. Aripiprazole is a medication that has been approved by the United States Food and Drug Administration (FDA) for the treatment of Schizophrenia.

A secondary aim of this research is to explore whether CYP 2D6 polymorphisms are related to side effects with aripiprazole. The goal of this research is to identify individuals who metabolize aripiprazole more rapidly or slowly, which will potentially help the clinician make dosing adjustments and decrease the risk of adverse events.


Condition Intervention Phase
Bipolar Disorder
Drug: Aripiprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Trial of Aripiprazole in Children and Adolescents With Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • YMRS & CGI [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • OAS CDRS-R [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2005
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Aripiprazole
    5-20 mg/day
Detailed Description:

The primary aim of this study is to assess the effectiveness, safety, and tolerability of aripiprazole for the treatment of children and adolescents with bipolar disorder. The secondary aim of this study is to determine if common polymorphic variations in the CYP 2D6 gene underlie the inter-individual variability in aripiprazole systemic drug exposure and the occurrence of treatment emergent side effects.

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or Females; between the ages of 7 years 0 months to 17 years 12 months
  2. Bipolar I Disorder, mixed or manic episode, psychotic or non-psychotic, according to DSM IV criteria.
  3. Score of > 20 on the Y-MRS at baseline.
  4. Ability and willingness to provide assent and informed written consent from at least one parent or legal guardian
  5. No current general medical illnesses requiring medication that would effect interpretation of study outcomes.
  6. Subjects must have at least normal intelligence.
  7. Female patients of childbearing potential must be using a reliable method of contraception, e.g. hormonal contraceptives, Depo-Provera, double-barrier methods (e.g. condom and diaphragm, condom and foam, condom and sponge) or abstinence). Females of childbearing potential must have a negative serum pregnancy test immediately prior to study entry.
  8. Must be able to swallow oral medication (tablets).

Exclusion Criteria:

  1. A current or lifetime DSM-IV diagnosis of schizophrenia, autistic disorder, schizoaffective disorder, pervasive developmental disorder, or obsessive compulsive disorder
  2. Known IQ < 70
  3. Patients with high suicide risk defined as any serious suicide attempt that required medical intervention or current suicide risk that cannot be safely managed as determined by the clinical judgment of the investigator.
  4. Concurrent cognitive behavioral psychotherapy.
  5. Present or past (within 3 months) DSM-IV diagnosis of substance abuse/dependence.
  6. Female patients who are pregnant, trying to become pregnant, nursing an infant, or not using a reliable form of contraception.
  7. Bipolar subjects who are currently stable on mood stabilizers or atypical neuroleptics.
  8. Patient has failed on a previous adequate course of aripiprazole.
  9. A known hypersensitivity to aripiprazole or to any of its components.
  10. Participated in an investigational drug/device trial within the last 30 days.
  11. Patients with severe renal insufficiency, defined as creatinine clearance <30ml/min. by history or by lab findings.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00221416

Sponsors and Collaborators
University of Cincinnati
Children's Hospital Medical Center, Cincinnati
Bristol-Myers Squibb
Investigators
Principal Investigator: Robert A Kowatch, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: Robert Kowatch, Principal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT00221416     History of Changes
Other Study ID Numbers: 04-7-11
Study First Received: September 14, 2005
Last Updated: June 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
child
adolescent

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

ClinicalTrials.gov processed this record on April 17, 2014