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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

January 19, 2005
August 6, 2012
July 2004
August 2006   (final data collection date for primary outcome measure)
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.

Not Provided
Complete list of historical versions of study NCT00102063 on ClinicalTrials.gov Archive Site
  • 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).

Not Provided
  • 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.
Not Provided
 
Aripiprazole in Adolescents With Schizophrenia
Aripiprazole in Adolescents With Schizophrenia

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Aripiprazole tablet, 10 mg
    Aripiprazole tablet 10 mg po qd x 42 days
    Other Name: OPC-14597
  • Drug: Aripiprazole tablet, 30 mg
    Aripiprazole tablet 30 mg po qd x 42 days
    Other Name: OPC-14597
  • Drug: Placebo tablet
    Placebo tablet po qd x 42 days
  • 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
    Intervention: Drug: Aripiprazole tablet, 10 mg
  • 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
    Intervention: Drug: Aripiprazole tablet, 30 mg
  • Placebo Comparator: Placebo Group
    Participants were given a single pill administered once daily
    Intervention: Drug: Placebo tablet

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
302
August 2006
August 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Primary diagnosis of Schizophrenia 1

Exclusion Criteria:

  • Patients diagnosed with schizoaffective disorder, major depressive disorder, delirium, or bipolar disorder
Both
13 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00102063
31-03-239
Not Provided
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Development & Commercialization, Inc.
Not Provided
Study Director: Margaretta Nyilas, M.D. Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Development & Commercialization, Inc.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP