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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Robert L Findling, MD, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT00194012
First received: September 11, 2005
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Other: Placebo
Drug: Aripiprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Aripiprazole in At-Risk Children With Symptoms of Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:
  • Youth Mania Rating Scale (YMRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 59
Study Start Date: August 2004
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: placebo
Patients randomly assigned to placebo, a drug reduction schedule was generated so that the taper of medication occured over the course of the first 4 weeks of phase 2.
Other: Placebo
Addressed in arm description
Other Name: Placebo
Active Comparator: Aripiprazole
Patients randomly assigned to aripiprazole, attempts were made to keep doses of aripiprazole consistent during the course of phase 2.
Drug: Aripiprazole
Addressed in arm description
Other Name: Abilify

Detailed 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 APZ (aripiprazole) ; 2) participated in the blinded portion of the clinical trial for a minimum of 4 weeks.

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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-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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00194012

Locations
United States, Ohio
University Hospitals Case Medical Center - Walker Building
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals of Cleveland
Bristol-Myers Squibb
Investigators
Principal Investigator: Robert L Findling, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Robert L Findling, MD, Director, Division of Child and Adolescent Psychiatry, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT00194012     History of Changes
Other Study ID Numbers: At Risk
Study First Received: September 11, 2005
Results First Received: June 26, 2013
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University Hospitals of Cleveland:
bipolar disorder

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 July 22, 2014