Aripiprazole Once-monthly in Patients With Schizophrenia
Information source: H. Lundbeck A/S
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Aripiprazole once-monthly (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: H. Lundbeck A/S Official(s) and/or principal investigator(s): Email contact via H. Lundbeck A/S, Study Director, Affiliation: LundbeckClinicalTrials@lundbeck.com
Summary
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.
Clinical Details
Official title: Interventional, Open-label, Flexible-dose Extension Study of Aripiprazole Once-monthly in Patients With Schizophrenia
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Safety and tolerabilityRisk of suicidality
Secondary outcome: Mean change from Baseline in subjective well-being using SWN-SMean change from Baseline in clinical global impression Mean change from Baseline in quality of life Mean change from Baseline in quality of life using QLS Mean change from Baseline in tolerability and quality of life using TooL Mean change from Baseline to identify individuals with sexual dysfunction Mean change from Baseline in the patient's readiness to work
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
US006, San Diego, California 92102, United States
Additional Information
Starting date: October 2013
Last updated: May 8, 2015
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