Clinical trial NCT00102063: Aripiprazole in Adolescents With Schizophrenia
Official title: Aripiprazole in Adolescents With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Aripiprazole
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2005-01-20
Enrollment: 302
Sex: ALL
Minimum age (years): 13
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 aripiprazole in adolescent patients with schizophrenia for a period of at least 6 weeks.


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of Schizophrenia 1

Exclusion Criteria:

* Patients diagnosed with schizoaffective disorder, major depressive disorder, delirium, or bipolar disorder

Primary outcomes:
measure: Change in Positive and Negative Syndrome Scale (PANSS) Total Score
timeFrame: Baseline and Day 42
Secondary outcomes:
measure: Change in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score
timeFrame: Baseline and Day 42
measure: Change in Positive and Negative Syndrome Scale (PANSS) Negative Subscale Score
timeFrame: Baseline and Day 42
measure: Change in Clinical Global Impression (CGI) Severity Score
timeFrame: Baseline and Day 42
measure: Clinical Global Impression (CGI) Improvement Score
timeFrame: Baseline and Day 42
measure: Change in Children's Global Assessment Scale (CGAS) Score
timeFrame: Baseline and Day 42
Other outcomes:
measure: Change in Pediatric Quality of Life Enjoyment and Satisfaction (PQLES) Questionnaire Total Score
timeFrame: Baseline and Day 42
measure: Patients Achieving Remission
timeFrame: Baseline and Day 42
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: Los Angeles
country: United States
facility: Local Institution
state: California
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: 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: Gainesville
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: Orange City
country: United States
facility: Local Institution
state: Florida
city: Tampa
country: United States
facility: Local Institution
state: Florida
city: Newnan
country: United States
facility: Local Institution
state: Georgia
city: Smyrna
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: Lake Charles
country: United States
facility: Local Institution
state: Louisiana
city: New Orleans
country: United States
facility: Local Institution
state: Louisiana
city: Medford
country: United States
facility: Local Institution
state: Massachusetts
city: Clinton Township
country: United States
facility: Local Institution
state: Michigan
city: Flowood
country: United States
facility: Local Institution
state: Mississippi
city: Kansas City
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
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: 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: Wauwatosa
country: United States
facility: Local Institution
state: Wisconsin
city: Rio Piedras
country: Puerto Rico
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: Local Institution
Study officials:
affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.
name: Margaretta Nyilas, M.D.
role: STUDY_DIRECTOR
References:
citation: Correll CU, Zhao J, Carson W, Marcus R, McQuade R, Forbes RA, Mankoski R. Early antipsychotic response to aripiprazole in adolescents with schizophrenia: predictive value for clinical outcomes. J Am Acad Child Adolesc Psychiatry. 2013 Jul;52(7):689-698.e3. doi: 10.1016/j.jaac.2013.04.018. Epub 2013 Jun 5.
citation: Robb AS, Carson WH, Nyilas M, Ali M, Forbes RA, Iwamoto T, Assuncao-Talbott S, Whitehead R, Pikalov A. Changes in positive and negative syndrome scale-derived hostility factor in adolescents with schizophrenia treated with aripiprazole: post hoc analysis of randomized clinical trial data. J Child Adolesc Psychopharmacol. 2010 Feb;20(1):33-8. doi: 10.1089/cap.2008.0163.
citation: Findling RL, Robb A, Nyilas M, Forbes RA, Jin N, Ivanova S, Marcus R, McQuade RD, Iwamoto T, Carson WH. A multiple-center, randomized, double-blind, placebo-controlled study of oral aripiprazole for treatment of adolescents with schizophrenia. Am J Psychiatry. 2008 Nov;165(11):1432-41. doi: 10.1176/appi.ajp.2008.07061035. Epub 2008 Sep 2.