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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00221416
• Other study ID #: 04-7-11
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2005
• Last updated: June 26, 2013
• Start date: June 2005
• Est. completion date: December 2008

Study information

• Verified date: June 2013
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Aripiprazole
5-20 mg/day

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Cincinnati	Bristol-Myers Squibb, Children's Hospital Medical Center, Cincinnati

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	YMRS & CGI		6 weeks	No
Secondary	OAS CDRS-R		6 weeks	No