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Study of Aripiprazole (Abilify) Versus Placebo in Children With Subsyndromal Bipolar Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

Aripiprazole in At-Risk Children With Symptoms of Bipolar Disorder

NCT00194012•University Hospitals Cleveland Medical Center

View on ClinicalTrials.gov

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.

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

Eligibility

Age

5 - 17 years

Sex

ALL

Healthy Volunteers

Yes

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
+7 more criteria

Locations (1)

University Hospitals Case Medical Center - Walker Building

Cleveland, Ohio, United States

Key Dates

Start Date

August 1, 2004

Primary Completion Date

May 1, 2012

Completion Date

June 1, 2012

Last Updated

June 26, 2017

Enrollment

ACTUAL participants

Conditions

Bipolar Disorder

Interventions

Aripiprazole

DRUG

Placebo

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

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RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913

ManiaBipolar Disorder

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 26, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

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