Aripiprazole Once-monthly in Patients With Schizophrenia

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

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-03-31

Brief Summary

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To obtain information on the safety, tolerability and effectiveness of aripiprazole once-monthly in a manner consistent with its intended use in everyday clinical practice in patients with schizophrenia who completed Study 14724A / NCT01795547.

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Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aripiprazole once-monthly

Group Type EXPERIMENTAL

Aripiprazole once-monthly

Intervention Type DRUG

400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline

Interventions

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Aripiprazole once-monthly

400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline

Intervention Type DRUG

Other Intervention Names

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Abilify Maintena®

Eligibility Criteria

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Inclusion Criteria

* The patient is judged to potentially benefit from 24-week treatment with aripiprazole once-monthly according to the clinical opinion of the investigator.
* The patient agrees to protocol-defined use of effective contraception.

Exclusion Criteria

* The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 14724A / NCT01795547.
* The patient has a clinically significant unstable illness diagnosed during Study 14724A / NCT01795547.
* The patient is at significant risk of harming himself/herself or others according to the investigator's judgement or according to Columbia-Suicide Severity Rating Scale (C-SSRS).
* The patient has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability or efficacy, or interfere with the conduct or interpretation of the study.
* The patient has one or more clinical laboratory test values outside the reference range, based on the blood or urine samples taken during the conduct of Study 14724A / NCT01795547 that are, in the investigator's opinion, of potential risk to the patient's safety.
* The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No