Aripiprazole Once-monthly in Patients With Schizophrenia



Status:Recruiting
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 60
Updated:4/13/2015
Start Date:October 2013
Contact:Email contact via H. Lundbeck A/S
Email:LundbeckClinicalTrials@lundbeck.com

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Interventional, Open-label, Flexible-dose Extension Study of Aripiprazole Once-monthly in Patients With Schizophrenia

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.


Patients will be recruited among those who complete treatment with aripiprazole in Study
14724A / NCT01795547.

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.

Other inclusion and exclusion criteria may apply.
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San Diego, California 92102
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