Clinical trial NCT00110461: Aripiprazole in Children and Adolescents With Bipolar I Disorder
Official title: A Phase III Trial to Test the Safety and Efficacy of Two Doses of Aripiprazole in Child and Adolescent Patients With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Keywords: Aripiprazole
Bipolar I Disorder, Manic or Mixed Episode with or without Psychotic Features
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2005-05-10
Enrollment: 296
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features.


Eligibility criteria: Inclusion Criteria:

* Child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features

Exclusion Criteria:

* Patients with certain other psychological disorders
* Patients with a co-morbid serious, uncontrolled systemic illness
* Patients with significant risk of committing suicide

Primary outcomes:
measure: Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 30
timeFrame: Baseline and Week 30
measure: Change in Children's Global Assessment Scale (CGAS) Total Score at Week 4
timeFrame: Baseline and Week 4
measure: Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4
timeFrame: Baseline and Week 4
measure: Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 4
timeFrame: Baseline and Week 4
measure: Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 4
timeFrame: Baseline and Week 4
measure: Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 4
timeFrame: Baseline and Week 4
measure: Change in Children's Global Assessment (CGAS) Total Score at Week 30
timeFrame: Baseline and Week 30
measure: Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30
timeFrame: Baseline and Week 30
measure: Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4
timeFrame: Baseline and Week 4
measure: Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30
timeFrame: Baseline and Week 30
measure: Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4
timeFrame: Baseline and Week 4
measure: Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30
timeFrame: Baseline and Week 30
measure: Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 30
timeFrame: Baseline and Week 30
measure: Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 30
timeFrame: Baseline and Week 30
measure: Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 4
timeFrame: Baseline and Week 4
measure: Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 30
timeFrame: Baseline and Week 30
measure: Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 4
timeFrame: Baseline and Week 4
measure: Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 30
timeFrame: Baseline and Week 30
measure: Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 4
timeFrame: Baseline and Week 4
measure: Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 30
timeFrame: Baseline and Week 30
measure: Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 30
timeFrame: Baseline and Week 30
measure: Subject Response to Treatment at Week 4
timeFrame: Baseline and Week 4
measure: Subject Response to Treatment at Week 30
timeFrame: Baseline and Week 30
measure: Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4
timeFrame: Baseline and Week 4
measure: Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30
timeFrame: Baseline and Week 30
measure: Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4
timeFrame: Baseline and Week 4
measure: Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30
timeFrame: Baseline and Week 30
measure: Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4
timeFrame: Baseline and Week 4
measure: Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30
timeFrame: Baseline and Week 30
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Local Institution
state: Arizona
city: Little Rock
country: United States
facility: Local Institution
state: Arkansas
city: National City
country: United States
facility: Local Institution
state: California
city: Orange
country: United States
facility: Local Institution
state: California
city: Pasadena
country: United States
facility: Local Institution
state: California
city: Sacramento
country: United States
facility: Local Institution
state: California
city: San Diego
country: United States
facility: Local Institution
state: California
city: Stanford
country: United States
facility: Local Institution
state: California
city: Washington
country: United States
facility: Local Institution
state: District of Columbia
city: Altamonte Springs
country: United States
facility: Local Institution
state: Florida
city: Hialeah
country: United States
facility: Local Institution
state: Florida
city: Jacksonville
country: United States
facility: Local Institution
state: Florida
city: Miami
country: United States
facility: Local Institution
state: Florida
city: North Miami
country: United States
facility: Local Institution
state: Florida
city: Tampa
country: United States
facility: Local Institution
state: Florida
city: Atlanta
country: United States
facility: Local Institution
state: Georgia
city: Smyrna
country: United States
facility: Local Institution
state: Georgia
city: Boise
country: United States
facility: Local Institution
state: Idaho
city: Chicago
country: United States
facility: Local Institution
state: Illinois
city: Libertyville
country: United States
facility: Local Institution
state: Illinois
city: Indianapolis
country: United States
facility: Local Institution
state: Indiana
city: Kansas City
country: United States
facility: Local Institution
state: Kansas
city: Newton
country: United States
facility: Local Institution
state: Kansas
city: Lexington
country: United States
facility: Local Institution
state: Kentucky
city: Baton Rouge
country: United States
facility: Local Institution
state: Louisiana
city: Lake Charles
country: United States
facility: Local Institution
state: Louisiana
city: Shreveport
country: United States
facility: Local Institution
state: Louisiana
city: Cambridge
country: United States
facility: Local Institution
state: Massachusetts
city: Medford
country: United States
facility: Local Institution
state: Massachusetts
city: Clinton Township
country: United States
facility: Local Institution
state: Michigan
city: Rochester Hills
country: United States
facility: Local Institution
state: Michigan
city: Kansas City
country: United States
facility: Local Institution
state: Missouri
city: St. Louis
country: United States
facility: Local Institution
state: Missouri
city: Las Vegas
country: United States
facility: Local Institution
state: Nevada
city: Elmsford
country: United States
facility: Local Institution
state: New York
city: New York City
country: United States
facility: Local Institution
state: New York
city: Rochester
country: United States
facility: Local Institution
state: New York
city: Stony Brook
country: United States
facility: Local Institution
state: New York
city: Cincinnati
country: United States
facility: Local Institution
state: Ohio
city: Cleveland
country: United States
facility: Local Institution
state: Ohio
city: Oklahoma City
country: United States
facility: Local Institution
state: Oklahoma
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: Charleston
country: United States
facility: Local Institution
state: South Carolina
city: Memphis
country: United States
facility: Local Institution
state: Tennessee
city: Bellaire
country: United States
facility: Local Institution
state: Texas
city: Fort Worth
country: United States
facility: Local Institution
state: Texas
city: Houston
country: United States
facility: Local Institution
state: Texas
city: San Antonio
country: United States
facility: Local Institution
state: Texas
city: Herndon
country: United States
facility: Local Institution
state: Virginia
city: Richmond
country: United States
facility: Local Institution
state: Virginia
city: Kirkland
country: United States
facility: Local Institution
state: Washington
city: Spokane
country: United States
facility: Local Institution
state: Washington
city: Milwaukee
country: United States
facility: Local Institution
state: Wisconsin
Study officials:
affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.
name: Margaretta Nyilas, MD
role: STUDY_DIRECTOR
References:
citation: Youngstrom E, Zhao J, Mankoski R, Forbes RA, Marcus RM, Carson W, McQuade R, Findling RL. Clinical significance of treatment effects with aripiprazole versus placebo in a study of manic or mixed episodes associated with pediatric bipolar I disorder. J Child Adolesc Psychopharmacol. 2013 Mar;23(2):72-9. doi: 10.1089/cap.2012.0024. Epub 2013 Mar 12.
citation: Findling RL, Correll CU, Nyilas M, Forbes RA, McQuade RD, Jin N, Ivanova S, Mankoski R, Carson WH, Carlson GA. Aripiprazole for the treatment of pediatric bipolar I disorder: a 30-week, randomized, placebo-controlled study. Bipolar Disord. 2013 Mar;15(2):138-49. doi: 10.1111/bdi.12042.
citation: Mankoski R, Zhao J, Carson WH, Mathew SJ, Forbes RA. Young mania rating scale line item analysis in pediatric subjects with bipolar I disorder treated with aripiprazole in a short-term, double-blind, randomized study. J Child Adolesc Psychopharmacol. 2011 Aug;21(4):359-64. doi: 10.1089/cap.2010.0100. Epub 2011 Aug 8.
citation: Findling RL, Nyilas M, Forbes RA, McQuade RD, Jin N, Iwamoto T, Ivanova S, Carson WH, Chang K. Acute treatment of pediatric bipolar I disorder, manic or mixed episode, with aripiprazole: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2009 Oct;70(10):1441-51. doi: 10.4088/JCP.09m05164yel.