Aripiprazole in Adolescents With Schizophrenia (APEX 239)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00102063
First received: January 19, 2005
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: Aripiprazole tablet, 10 mg
Drug: Aripiprazole tablet, 30 mg
Drug: Placebo tablet
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Aripiprazole in Adolescents With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • Change in Positive and Negative Syndrome Scale (PANSS) Total Score [ Time Frame: Baseline and Day 42 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline and Day 42 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline and Day 42 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline and Day 42 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline and Day 42 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline and Day 42 ] [ Designated as safety issue: No ]

    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).



Other Outcome Measures:
  • Change in Pediatric Quality of Life Enjoyment and Satisfaction (PQLES) Questionnaire Total Score [ Time Frame: Baseline and Day 42 ] [ Designated as safety issue: No ]

    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).


  • Patients Achieving Remission [ Time Frame: Baseline and Day 42 ] [ Designated as safety issue: No ]
    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.


Enrollment: 302
Study Start Date: July 2004
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aripiprazole 10 mg/day Group
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
Drug: Aripiprazole tablet, 10 mg
Aripiprazole tablet 10 mg po qd x 42 days
Other Name: OPC-14597
Active Comparator: Aripiprazole 30 mg/day Group
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
Drug: Aripiprazole tablet, 30 mg
Aripiprazole tablet 30 mg po qd x 42 days
Other Name: OPC-14597
Placebo Comparator: Placebo Group
Participants were given a single pill administered once daily
Drug: Placebo tablet
Placebo tablet po qd x 42 days

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary diagnosis of Schizophrenia 1

Exclusion Criteria:

  • Patients diagnosed with schizoaffective disorder, major depressive disorder, delirium, or bipolar disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00102063

  Show 55 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
Study Director: Margaretta Nyilas, M.D. Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

No publications provided by Otsuka Pharmaceutical Development & Commercialization, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT00102063     History of Changes
Other Study ID Numbers: 31-03-239
Study First Received: January 19, 2005
Results First Received: May 11, 2012
Last Updated: August 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Schizophrenia
Aripiprazole

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 15, 2014