Study of Aripiprazole (Abilify) in Children With Symptoms of Mania

NCT00194077 | Completed Phase 3 Results DMC

• 1 other identifier: Children with Mania
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to look at the safety and effectiveness of aripiprazole (abilify) in children with bipolar disorder and to examine whether or not patients that respond to initial mood stabilization benefit from continued pharmacotherapy.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Time in Weeks to Discontinuation

  Time in weeks to discontinuation due to any reason, including mood event, adverse event, or other.

  up to 72 weeks

Study Arms (2)

Aripiprazole

ACTIVE COMPARATOR

Phase I and Phase III are open label Abilify phases where all subjects receive active Abilify

Drug: Aripiprazole

Placebo

PLACEBO COMPARATOR

in Phase 2 subjects are randomized to either placebo or abilify for up to 72 weeks

Drug: Placebo

Interventions

Aripiprazole DRUG

dosing will occur at 2mg, 5mg, 7mg, 10 mg, 12mg, or 15 mg based on weight, side effects and efficacy

Also known as: Abilify

Aripiprazole

Placebo DRUG

subjects in phase 2 will be randomized to active abilify or placebo

Placebo

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Outpatients ages 4-9 years (inclusive)
• Patients who are anticipated to have a Young Mania Rating Scale (Young et al. 1978) of 15 or higher at baseline
• Meet DSM-IV criteria for bipolar disorder type 1 or 2, cyclothymia, or bipolar disorder not otherwise specified (BP NOS) based on the results of both a semi-structured diagnostic research assessment (K-SADS-PL supplemented with mood disorder 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.

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 a documented APZ dose as monotherapy treatment 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 disorders
• 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 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)

Sponsors & Collaborators

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

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (2)

• Findling RL, Youngstrom EA, McNamara NK, Stansbrey RJ, Wynbrandt JL, Adegbite C, Rowles BM, Demeter CA, Frazier TW, Calabrese JR. Double-blind, randomized, placebo-controlled long-term maintenance study of aripiprazole in children with bipolar disorder. J Clin Psychiatry. 2012 Jan;73(1):57-63. doi: 10.4088/JCP.11m07104. Epub 2011 Nov 29.

  PMID: 22152402 RESULT

• Findling RL, McNamara NK, Youngstrom EA, Stansbrey RJ, Frazier TW, Lingler J, Otto BD, Demeter CA, Rowles BM, Calabrese JR. An open-label study of aripiprazole in children with a bipolar disorder. J Child Adolesc Psychopharmacol. 2011 Aug;21(4):345-51. doi: 10.1089/cap.2010.0102. Epub 2011 Aug 8.

  PMID: 21823912 DERIVED

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

Limitations and Caveats

No deaths occured during this study.

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: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: January 7, 2015
• Results First Posted: December 5, 2013

Record last verified: 2014-12

Locations

US (1)