Oral Aripiprazole Open-Label Rollover Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2012-07-31

Brief Summary

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The purpose of this study is to test the long-term safety and tolerability of oral aripiprazole in adolescent patients with schizophrenia.

Detailed Description

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Conditions

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Schizophrenia

Keywords

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Open Label Aripiprazole

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oral Aripiprazole

Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.

Group Type EXPERIMENTAL

Aripiprazole

Intervention Type DRUG

Flexible dose between 5 mg and 30 mg Aripiprazole tablets.

Interventions

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Aripiprazole

Flexible dose between 5 mg and 30 mg Aripiprazole tablets.

Intervention Type DRUG

Other Intervention Names

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ABILIFY®

Eligibility Criteria

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Inclusion Criteria

* Subjects with a confirmed Axis I Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia who must have completed Otsuka study 31-03-241 (NCT00102518) treatment of adolescent subjects with schizophrenia

Exclusion Criteria

* Patients with a co-morbid serious, uncontrolled systemic illness
* Patients with a significant risk of committing suicide

Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

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Argentina Croatia India Russia Serbia Ukraine

Other Identifiers

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31-05-243

Identifier Type: -

Identifier Source: org_study_id

Oral Aripiprazole Open-Label Rollover Study

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Oral Aripiprazole

Aripiprazole

Interventions

Aripiprazole

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.

Responsible Party

Locations

Study site

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Countries

Other Identifiers

31-05-243