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Completed

NCT Number: NCT00102063

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, Rio Piedras, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary diagnosis of Schizophrenia 1

Exclusion criteria

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

Treatment and study plan

Aripiprazole tablet, 10 mg

Drug

Aripiprazole tablet 10 mg po qd x 42 days

Other names: OPC-14597

Aripiprazole tablet, 30 mg

Drug

Aripiprazole tablet 30 mg po qd x 42 days

Other names: OPC-14597

Placebo Tablet

Drug

Placebo tablet po qd x 42 days

Primary outcomes

  1. Change in Positive and Negative Syndrome Scale (PANSS) Total Score

    Time frame: Baseline and Day 42

    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 outcomes

  1. Change in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score

    Time frame: Baseline and Day 42

    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.

  2. Change in Positive and Negative Syndrome Scale (PANSS) Negative Subscale Score

    Time frame: Baseline and Day 42

    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.

  3. Change in Clinical Global Impression (CGI) Severity Score

    Time frame: Baseline and Day 42

    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).

  4. Clinical Global Impression (CGI) Improvement Score

    Time frame: Baseline and Day 42

    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).

  5. Change in Children's Global Assessment Scale (CGAS) Score

    Time frame: Baseline and Day 42

    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 outcomes

  1. Change in Pediatric Quality of Life Enjoyment and Satisfaction (PQLES) Questionnaire Total Score

    Time frame: Baseline and Day 42

    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).

  2. Patients Achieving Remission

    Time frame: Baseline and Day 42

    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.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Registry information

Acronym: APEX 239

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Jan 20, 2005
Registry last updated
Aug 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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