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Aripiprazole in Adolescents With Schizophrenia (APEX 239)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aripiprazole tablet, 10 mg
Aripiprazole tablet, 30 mg
Placebo tablet
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Aripiprazole

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Primary diagnosis of Schizophrenia 1 Exclusion Criteria: Patients diagnosed with schizoaffective disorder, major depressive disorder, delirium, or bipolar disorder

Sites / Locations

  • Local Institution
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Aripiprazole 10 mg/day Group

Aripiprazole 30 mg/day Group

Placebo Group

Arm Description

Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25

Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25

Participants were given a single pill administered once daily

Outcomes

Primary Outcome Measures

Change in Positive and Negative Syndrome Scale (PANSS) Total Score
Change from baseline to last observed post-baseline value in PANSS total score, using the last observation carried forward. This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point scale of severity with 1 being absent to 7 being extreme. Minimum score is 30 which is best outcome; maximum score is 210 for worse outcome.

Secondary Outcome Measures

Change in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score
Change from baseline to last observed post-baseline value in PANSS positive subscale score, using the last observation carried forward. Scale consists of 7 positive symptom constructs each to be rated on a 7- point scale of severity with 1 = absent to 7 = extreme. Minimum score is 7 which is best outcome; maximum score is 49 for worse outcome.
Change in Positive and Negative Syndrome Scale (PANSS) Negative Subscale Score
Change from baseline to last observed post-baseline value in PANSS Negative Subscale score, using the last observation carried forward. Scale consists of 7 negative symptom constructs each to be rated on a 7- point scale of severity with 1 = absent to 7 = extreme. Minimum score is 7 which is best outcome; maximum score is 49 for worse outcome.
Change in Clinical Global Impression (CGI) Severity Score
Change from baseline to last observed post-baseline value in CGI severity score, using the last observation carried forward. Scale refers to the global impression of the subject with respect to severity of the illness. The scale rates the subject's severity of illness from 0 (not rated) to 1 (least severe) to 7 (most severe).
Clinical Global Impression (CGI) Improvement Score
Last observed post-baseline value in CGI improvement score, using the last observation carried forward. Scale refers to the global impression of the subject with respect to improvement of the illness. The scale rates the subject's severity of illness from 0 (not rated) to 1 (least severe) to 7 (most severe).
Change in Children's Global Assessment Scale (CGAS) Score
Change from baseline to last observed post-baseline value in CGAS score, using the last observation carried forward. Scale is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome).

Full Information

First Posted
January 19, 2005
Last Updated
August 6, 2012
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00102063
Brief Title
Aripiprazole in Adolescents With Schizophrenia
Acronym
APEX 239
Official Title
Aripiprazole in Adolescents With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Aripiprazole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aripiprazole 10 mg/day Group
Arm Type
Active Comparator
Arm Description
Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
Arm Title
Aripiprazole 30 mg/day Group
Arm Type
Active Comparator
Arm Description
Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Participants were given a single pill administered once daily
Intervention Type
Drug
Intervention Name(s)
Aripiprazole tablet, 10 mg
Other Intervention Name(s)
OPC-14597
Intervention Description
Aripiprazole tablet 10 mg po qd x 42 days
Intervention Type
Drug
Intervention Name(s)
Aripiprazole tablet, 30 mg
Other Intervention Name(s)
OPC-14597
Intervention Description
Aripiprazole tablet 30 mg po qd x 42 days
Intervention Type
Drug
Intervention Name(s)
Placebo tablet
Intervention Description
Placebo tablet po qd x 42 days
Primary Outcome Measure Information:
Title
Change in Positive and Negative Syndrome Scale (PANSS) Total Score
Description
Change from baseline to last observed post-baseline value in PANSS total score, using the last observation carried forward. This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point scale of severity with 1 being absent to 7 being extreme. Minimum score is 30 which is best outcome; maximum score is 210 for worse outcome.
Time Frame
Baseline and Day 42
Secondary Outcome Measure Information:
Title
Change in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score
Description
Change from baseline to last observed post-baseline value in PANSS positive subscale score, using the last observation carried forward. Scale consists of 7 positive symptom constructs each to be rated on a 7- point scale of severity with 1 = absent to 7 = extreme. Minimum score is 7 which is best outcome; maximum score is 49 for worse outcome.
Time Frame
Baseline and Day 42
Title
Change in Positive and Negative Syndrome Scale (PANSS) Negative Subscale Score
Description
Change from baseline to last observed post-baseline value in PANSS Negative Subscale score, using the last observation carried forward. Scale consists of 7 negative symptom constructs each to be rated on a 7- point scale of severity with 1 = absent to 7 = extreme. Minimum score is 7 which is best outcome; maximum score is 49 for worse outcome.
Time Frame
Baseline and Day 42
Title
Change in Clinical Global Impression (CGI) Severity Score
Description
Change from baseline to last observed post-baseline value in CGI severity score, using the last observation carried forward. Scale refers to the global impression of the subject with respect to severity of the illness. The scale rates the subject's severity of illness from 0 (not rated) to 1 (least severe) to 7 (most severe).
Time Frame
Baseline and Day 42
Title
Clinical Global Impression (CGI) Improvement Score
Description
Last observed post-baseline value in CGI improvement score, using the last observation carried forward. Scale refers to the global impression of the subject with respect to improvement of the illness. The scale rates the subject's severity of illness from 0 (not rated) to 1 (least severe) to 7 (most severe).
Time Frame
Baseline and Day 42
Title
Change in Children's Global Assessment Scale (CGAS) Score
Description
Change from baseline to last observed post-baseline value in CGAS score, using the last observation carried forward. Scale is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome).
Time Frame
Baseline and Day 42
Other Pre-specified Outcome Measures:
Title
Change in Pediatric Quality of Life Enjoyment and Satisfaction (PQLES) Questionnaire Total Score
Description
Change from baseline to last observed post-baseline value in PQLES total score, using the last observation carried forward. Scale consists of 14 items pertaining to daily life activities and satisfaction, and an overall assessment item. Each item will be rated on a five-point scale (1=very poor, 2=poor, 3=fair, 4=good, 5=very good) with a minimum score of 14 (better outcome) and a maximum score of 70 (worse outcome).
Time Frame
Baseline and Day 42
Title
Patients Achieving Remission
Description
The number of subjects achieving remission. Remission was defined as a score of mild or less (≤ 3) for items P1, P2, P3, N1, N4, N6, G5, and G9 in the PANSS score.
Time Frame
Baseline and Day 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary diagnosis of Schizophrenia 1 Exclusion Criteria: Patients diagnosed with schizoaffective disorder, major depressive disorder, delirium, or bipolar disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaretta Nyilas, M.D.
Organizational Affiliation
Otsuka Pharmaceutical Development & Commercialization, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
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Birmingham
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Alabama
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United States
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Little Rock
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Arkansas
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United States
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Costa Mesa
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Los Angeles
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California
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Orange
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Pasadena
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Sacramento
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San Diego
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Temecula
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United States
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Washington
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District of Columbia
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Altamonte Springs
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United States
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Ft. Lauderdale
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Gainesville
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Hialeah
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Jacksonville
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Miami
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North Miami
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Orange City
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Tampa
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Newnan
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Georgia
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Smyrna
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Honolulu
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Chicago
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Kansas City
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Lexington
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Lake Charles
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New Orleans
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Medford
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Clinton Township
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Flowood
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Kansas City
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Las Vegas
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Elmsford
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New York
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New York
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Olean
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Rochester
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Chapel Hill
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Cleveland
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Lyndhurst
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Oklahoma City
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Oklahoma
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Bala Cynwyd
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Philadelphia
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Memphis
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Tennessee
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United States
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Bellaire
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DeSoto
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Texas
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Houston
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San Antonio
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Salt Lake City
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Utah
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Richmond
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Kirkland
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Spokane
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Wauwatosa
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Wisconsin
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Rio Piedras
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Puerto Rico
Facility Name
Local Institution
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San Juan
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Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
23800482
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.
Results Reference
derived
PubMed Identifier
20166794
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.
Results Reference
derived
PubMed Identifier
18765484
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.
Results Reference
derived

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Aripiprazole in Adolescents With Schizophrenia

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