ClinicalTrials.Veeva

Menu

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

University Hospitals (UH) logo

University Hospitals (UH)

Status and phase

Completed
Phase 3

Conditions

Bipolar Disorder

Treatments

Drug: Aripiprazole
Drug: Placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00194012
At Risk

Details and patient eligibility

About

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.

Full 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.

Enrollment

62 patients

Sex

All

Ages

5 to 17 years old

Volunteers

Accepts Healthy Volunteers

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 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

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

62 participants in 2 patient groups, including a placebo group

Aripiprazole-Randomized Phase
Active Comparator group
Description:
Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
Treatment:
Drug: Aripiprazole
Placebo-Randomized Phase
Placebo Comparator group
Description:
Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
Treatment:
Drug: Placebo

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems