Aripiprazole Once-monthly in Patients With Schizophrenia

Completed · Phase 3

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT01959035

Run by

H. Lundbeck A/S

People needed

88

Starts

2013-10-01

Expected to finish

2015-03-01

Last updated by the study team

2017-03-17

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• US006 — San Diego, California, United States

Full record on ClinicalTrials.gov

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