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

NCT00194012 | Completed Phase 3 Results DMC

• 1 other identifier: At Risk
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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 parent with bipolar disorder and other family member with a mood disorder.

Conditions

Bipolar Disorder

Keywords

bipolar disorder

Outcome Measures

Primary Outcomes (3)

• Young 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.

  Baseline

• Young 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

• Young 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.

  Open-Label Extension - 6 weeks

Secondary Outcomes (12)

• Children's Depression Rating Scale-Revised (CDRS-R )

  Baseline

• CDRS-R Children's Depression Rating Scale-Revised

  12 weeks

• CDRS-R Children's Depression Rating Scale-Revised

  Open-Label Extension - 6 weeks

• Children's Global Assessment Scale (CGAS)

  Baseline

• Children's Global Assessment Scale (CGAS)

  12 weeks

Study Arms (2)

Aripiprazole-Randomized Phase

ACTIVE COMPARATOR

Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.

Drug: Aripiprazole

Placebo-Randomized Phase

PLACEBO COMPARATOR

Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.

Drug: Placebo

Interventions

Aripiprazole DRUG

Addressed in arm description.

Also known as: Abilify

Aripiprazole-Randomized Phase

Placebo DRUG

Addressed in arm description.

Placebo-Randomized Phase

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 Washington University 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

University Hospitals Case Medical Center - Walker Building

Cleveland, Ohio, 44106, United States

Location

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

Results Point of Contact

• Title: Robert Findling, MD, MBA, Director, Child and Adolescent Psychiatry
• Organization: Johns Hopkins University School of Medicine

rfindli1@jhmi.edu

410-614-3225

Study Officials

• Robert L Findling, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Child and Adolescent Psychiatry

Study Record Dates

• First Submitted: September 11, 2005
• First Posted: September 19, 2005
• Study Start: August 1, 2004
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 26, 2017
• Results First Posted: May 5, 2014

Record last verified: 2017-06

Locations

US (1)