Clinical trial NCT00102518: Aripiprazole Open-Label, Safety and Tolerability Study
Official title: A Multi-Center, Open-Label, Safety and Tolerability Study of Flexible-Dose Oral Aripiprazole (2 Mg-30 mg) in the Treatment of Adolescent Patients With Schizophrenia and 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: Schizophrenia
Bipolar Disorder
Keywords: Open Label
Aripiprazole
Bipolar I Disorder, Manic or Mixed Episode
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2005-01-31
Enrollment: 325
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the long-term safety and tolerability of aripiprazole in adolescent patients with schizophrenia, and child and adolescent patients with bipolar I disorder, manic or mixed episode.


Eligibility criteria: Inclusion Criteria:

* Adolescent patients with schizophrenia, or child and adolescent patients with bipolar I disorder, manic or mixed episode

Exclusion Criteria:

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

Primary outcomes:
measure: Percentage of Subjects Experiencing SAEs
timeFrame: Baseline and Week 23
Secondary outcomes:
measure: Change in Change in Positive and Negative Syndrome Scale (PANSS) Total Score
timeFrame: Baseline and Week 26
measure: Change in Young Mania Rating Scale (Y-MRS) Total Score
timeFrame: Baseline and Week 26
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution
state: Alabama
city: Little Rock
country: United States
facility: Local Institution
state: Arkansas
city: Costa Mesa
country: United States
facility: Local Institution
state: California
city: Fresno
country: United States
facility: Local Institution
state: California
city: Orange
country: United States
facility: Local Institution
state: California
city: Riverside
country: United States
facility: Local Institution
state: California
city: Rosemead
country: United States
facility: Local Institution
state: California
city: Sacramento
country: United States
facility: Local Institution
state: California
city: Temecula
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: Ft. Lauderdale
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: Orange City
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: Honolulu
country: United States
facility: Local Institution
state: Hawaii
city: Chicago
country: United States
facility: Local Institution
state: Illinois
city: Kansas City
country: United States
facility: Local Institution
state: Kansas
city: Lexington
country: United States
facility: Local Institution
state: Kentucky
city: Louisville
country: United States
facility: Local Institution
state: Kentucky
city: Lake Charles
country: United States
facility: Local Institution
state: Louisiana
city: Metairie
country: United States
facility: Local Institution
state: Louisiana
city: New Orleans
country: United States
facility: Local Institution
state: Louisiana
city: Somerville
country: United States
facility: Local Institution
state: Massachusetts
city: Clinton
country: United States
facility: Local Institution
state: Michigan
city: Kansas City
country: United States
facility: Local Institution
state: Missouri
city: St. Charles
country: United States
facility: Local Institution
state: Missouri
city: Elmsford
country: United States
facility: Local Institution
state: New York
city: New York
country: United States
facility: Local Institution
state: New York
city: Olean
country: United States
facility: Local Institution
state: New York
city: Rochester
country: United States
facility: Local Institution
state: New York
city: Chapel Hill
country: United States
facility: Local Institution
state: North Carolina
city: Cleveland
country: United States
facility: Local Institution
state: Ohio
city: Lyndhurst
country: United States
facility: Local Institution
state: Ohio
city: Oklahoma City
country: United States
facility: Local Institution
state: Oklahoma
city: Bala Cynwyd
country: United States
facility: Local Institution
state: Pennsylvania
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: Memphis
country: United States
facility: Local Institution
state: Tennessee
city: Bellaire
country: United States
facility: Local Institution
state: Texas
city: DeSoto
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: Salt Lake City
country: United States
facility: Local Institution
state: Utah
city: Kirkland
country: United States
facility: Local Institution
state: Washington
city: Seattle
country: United States
facility: Local Institution
state: Washington
city: Spokane
country: United States
facility: Local Institution
state: Washington
city: Wauwatosa
country: United States
facility: Local Institution
state: Wisconsin
Study officials:
References: