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

NCT00221416 | Completed Phase 3

• 1 other identifier: 04-7-11
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Bipolar Disorder

Keywords

child; adolescent

Outcome Measures

Primary Outcomes (1)

• YMRS & CGI

  6 weeks

Secondary Outcomes (1)

• OAS CDRS-R

  6 weeks

Interventions

Aripiprazole DRUG

5-20 mg/day

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or Females; between the ages of 7 years 0 months to 17 years 12 months
• Bipolar I Disorder, mixed or manic episode, psychotic or non-psychotic, according to DSM IV criteria.
• Score of \> 20 on the Y-MRS at baseline.
• Ability and willingness to provide assent and informed written consent from at least one parent or legal guardian
• No current general medical illnesses requiring medication that would effect interpretation of study outcomes.
• Subjects must have at least normal intelligence.
• 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.
• Must be able to swallow oral medication (tablets).

You may not qualify if:

• A current or lifetime DSM-IV diagnosis of schizophrenia, autistic disorder, schizoaffective disorder, pervasive developmental disorder, or obsessive compulsive disorder
• Known IQ \< 70
• 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.
• Concurrent cognitive behavioral psychotherapy.
• Present or past (within 3 months) DSM-IV diagnosis of substance abuse/dependence.
• Female patients who are pregnant, trying to become pregnant, nursing an infant, or not using a reliable form of contraception.
• Bipolar subjects who are currently stable on mood stabilizers or atypical neuroleptics.
• Patient has failed on a previous adequate course of aripiprazole.
• A known hypersensitivity to aripiprazole or to any of its components.
• Participated in an investigational drug/device trial within the last 30 days.
• Patients with severe renal insufficiency, defined as creatinine clearance \<30ml/min. by history or by lab findings.

Sponsors & Collaborators

• University of Cincinnati: lead
• Children's Hospital Medical Center, Cincinnati: collaborator
• Bristol-Myers Squibb: collaborator

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Robert A Kowatch, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Study Start: June 1, 2005
• Primary Completion: October 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 27, 2013

Record last verified: 2013-06