Status:
COMPLETED
Lurasidone Extended Use Study
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Schizophrenia
Bipolar Disorder
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
This is an open-label continuation study designed to monitor the safety, tolerability and effectiveness of lurasidone in subjects who have completed participation in a lurasidone extension study (NCT0...
Eligibility Criteria
Inclusion
- The subject or legal guardian provides written informed consent. For eligible subjects under age 18, verbal assent is also required.
- The subject has completed the extension phase of a prior lurasidone clinical study. Eligible subjects may enroll into this continuation study directly (or within 10 days) after completing the extension phase of a prior lurasidone clinical study. Subjects that have completed an extension study prior to the initiation of this protocol at the study site, may participate in this study up to 3 months after completion of the extension phase of the prior lurasidone study.
- The subject is judged by the Investigator to be suitable for participation in a clinical study involving open-label lurasidone treatment and is able to comply with the protocol.
- The subject, in the Investigator's judgment, may benefit from continued treatment with lurasidone
Exclusion
- The subject is considered by the Investigator, to be at imminent risk for homicidal or suicidal behavior.
- The subject resides in a country where lurasidone has been approved for any indication.
- The subject is currently enrolled in any other investigational study.
- The subject answers "yes" to "Suicidal Ideation" Items 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT01485640
Start Date
June 1 2011
End Date
February 1 2014
Last Update
November 4 2016
Active Locations (46)
Enter a location and click search to find clinical trials sorted by distance.
1
Okanagan Clinical Trials
Kelowna, British Columbia, Canada, V1Y 1Z9
2
Centro de Investigaciones y Proyectos en Neurociencias CIPNA Investigations
Barranquilla, Colombia
3
E.S.E. Hospital Mental de Antioquia
Bello, Colombia
4
CISNE - UIC Campo Abierto
Bogotá, Colombia