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Aripiprazole Open-Label, Safety and Tolerability Study (APEX 241)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00102518
First received: January 29, 2005
Last updated: July 31, 2012
Last verified: July 2012
History of Changes
  Purpose

The purpose of this study is to test the long-term safety and tolerability of aripiprazole in adolescent patients with schizophrenia, and child and adolescent patients with bipolar I disorder, manic or mixed episode.


Condition Intervention Phase
Schizophrenia
Bipolar Disorder
 Drug: Aripiprazole
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Open-Label, Safety and Tolerability Study of Flexible-Dose Oral Aripiprazole (2 Mg-30 mg) in the Treatment of Adolescent Patients With Schizophrenia and Child and Adolescent Patients With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Percentage of Subjects Experiencing SAEs [ Time Frame: Baseline and Week 23 ] [ Designated as safety issue: Yes ]
    Percentage of Subjects Experiencing SAEs. The incidences of SAEs are summarized by system organ class in CT-8.5.1; by system organ class and MedDRA preferred term and by system organ class, MedDRA preferred term, and severity.


Secondary Outcome Measures:
  • Change in Change in Positive and Negative Syndrome Scale (PANSS) Total Score [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]

    Change from baseline to the last scheduled post-baseline evaluation in PANSS total score, using observed cases (assessments performed at baseline and weeks 4, 12, and 26).

    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.


  • Change in Young Mania Rating Scale (Y-MRS) Total Score [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]

    Change from baseline to last scheduled post-baseline evaluation in YMRS total score, using observed cases (assessments performed at baseline and weeks 4, 12, and 26).

    The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms).



Enrollment: 325
Study Start Date: September 2004
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NCT00102063 and NCT00110461 Subjects
All subjects had either completed or had withdrawn from the double-blind extension phase of study NCT00110461 (OPDC 31-03-240) and study NCT00102063 (OPDC 31-03-239).
 Drug: Aripiprazole
2 to 30 mg/day orally (2, 5, 10, 15, 20, 25, or 30 mg/day); tablets in strengths of 2, 5, 10, and 15 mg were used to achieve desired doses
Other Name: OPC-14597

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adolescent patients with schizophrenia, or child and adolescent patients with bipolar I disorder, manic or mixed episode

Exclusion Criteria:

  • Patients with a co-morbid serious, uncontrolled systemic illness
  • Patients with a significant risk of committing suicide
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00102518

  Show 50 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT00102518     History of Changes
Other Study ID Numbers: 31-03-241
Study First Received: January 29, 2005
Results First Received: May 16, 2012
Last Updated: July 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Open Label
Aripiprazole
Bipolar I Disorder, Manic or Mixed Episode

Additional relevant MeSH terms:
Bipolar Disorder
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
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 May 16, 2013