Study of Aripiprazole (Abilify) Versus Placebo in Children With Subsyndromal Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

Aripiprazole in At-Risk Children With Symptoms of Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00194012
• Other study ID #: At Risk
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2005
• Last updated: December 17, 2014
• Start date: August 2004
• Est. completion date: June 2012

Study information

• Verified date: December 2014
• Source: University Hospital Case Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the effectiveness and tolerability/safety of aripiprazole (abilify) in children with subsyndromal symptoms of bipolar disorder who also have a bipolar parent and other family member with a mood disorder.

Description:

This will be a double-blind, placebo-controlled, parallel-arm, randomized clinical trial that will last up to 12 weeks.

This placebo-controlled portion will be followed by a 6-week open label extension/stabilization phase. In order to be eligible for participation in the extension/stabilization phase, subjects must: 1) in the investigator's opinion have had no dose-limiting side effects likely to be attributable to aripiprazole (APZ); 2) participated in the blinded portion of the clinical trial for a minimum of 4 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 17 Years

Eligibility

Inclusion Criteria:

• Outpatients ages 5-17 years (inclusive)

• Patients, who in the investigator's opinion have substantial symptoms of mania, depression, or both within the past 2 weeks such that treatment with a pharmacological agent is warranted

• Currently meets Diagnostic Statistical Manual of Mental Disorders (DSM-IV) criteria for either cyclothymia, or bipolar disorder not otherwise specified (BP NOS) based on the results of both a semi-structured diagnostic research assessment, Present and Lifetime Version (K-SADS-Present and Lifetime (PL) supplemented with sections from the WASH-U K-SADS) (Geller et al., 2001; Kaufman et al., 1997) and a clinical interview with a child and adolescent psychiatrist.

• Offspring of a parent with a bipolar spectrum disorder (based on the results of either the Mini International Neuropsychiatric Interview (MINI)(Sheehan et al., 1998) or the Family History Method (FH-RDC)(Andreasen et al., 1977)

• Has another first or second degree relative with a mood disorder determined by the results of either the MINI or the FH-RDC

• Has participated in at least 4 sessions of psychotherapy specifically focused on the symptoms/management of pediatric mood disorder and continues to have clinically significant symptomatology

Exclusion Criteria:

• Patients who have a history of intolerance to APZ at doses of 0.1mg/kg/day

• Patients who have experienced a manic episode with documented treatment with APZ monotherapy at a dose of 0.2 mg/kg/day

• Patients with an active neurological/medical disorder for which treatment with APZ would be contraindicated

• Patients with clinical evidence of autistic disorder, Asperger's disorder, Rett's syndrome or other pervasive developmental disorder

• Patients with clinical evidence of mental retardation

• Patients who are known to be allergic or hypersensitive to aripiprazole

• Patients who are unable to swallow pills/capsules

• Patients for whom the need for hospitalization during the course of the study appears likely

• Patients who have started a new psychotherapeutic intervention within less than 4 weeks of randomization

• Patients who have a general medical or neurological condition (including clinically significant abnormalities on screening laboratories) that may be considered to be the etiology of the patient's mood disorder

• Patients who have a general medical or neurological condition for which treatment with an atypical antipsychotic would be contraindicated (e.g. tardive dyskinesia)

• Patients who have a general medical or neurological condition that could interfere with the interpretation of clinical response to APZ treatment

• Patients taking psychotropic agents (other than psychostimulants) within one week of baseline (2 weeks for fluoxetine; 3 days for psychostimulants)

• Patients with a suicide attempt requiring medical/psychiatric care within the past 6 months

• Has met DSM-IV criteria for drug/alcohol abuse or dependence within the past 6 months

• Females who are currently pregnant or lactating

• Sexually active females, who in the investigators' opinion are not using an adequate form of birth control

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Other:
• Placebo
Addressed in arm description

Drug:
• Aripiprazole
Addressed in arm description

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center - Walker Building	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Case Medical Center	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Youth Mania Rating Scale (YMRS)	The Young Mania Rating Scale (YMRS) has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. Each item o the YMRS is given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. Total score ranges from 0 to 60, with higher being more severe mania.	12 weeks	No