A Twelve Week, Open Label Extension Study in Patients With Schizophrenia
Status: | Completed |
---|---|
Conditions: | Schizophrenia |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/30/-0001 |
Start Date: | April 2012 |
End Date: | July 2013 |
Contact: | Study Manager |
Phone: | 1-866-503-6351 |
A Twelve Week, Multicenter, Open Label Extension Study in Subjects With Schizophrenia
This is a 12-week, multi-center, open-label extension study designed to evaluate the
longer-term safety, tolerability and effectiveness of lurasidone for the treatment of
subjects with schizophrenia.
This is a 12-week, multi-center, open-label extension study designed to evaluate the
longer-term safety, tolerability and effectiveness of lurasidone for the treatment of
subjects with schizophrenia who have participated in Study D1050238, a double-blind,
placebo-controlled, randomized withdrawal study of lurasidone for the maintenance treatment
of subjects with schizophrenia. Subjects who have completed the 28-week double-blind phase
or who have experienced a protocol-defined relapse event during the double-blind phase of
study D1050238 will have the option to participate in this study. In addition, if/when the
study is discontinued by the sponsor, all subjects participating in the open-label phase and
the double-blind phase of study D1050238 will have the option to participate in this
extension study
Inclusion Criteria:
- Subject has agreed to participate by providing written informed consent.
- Subject will be eligible to participate if one of the following criteria is met:
- Subject has completed the 28-week double-blind phase of study D1050238
- Subject has experienced a protocol-defined relapse event during the double- blind
phase in study D1050238
- Subject is participating in the open-label or double-blind phase of study D1050238
if/when study D1050238 is terminated by the sponsor.
- Subject has completed all required assessments on the final study visit (Study Visit
Number 42) in study D1050238.
- Subject is judged by the Investigator to be suitable for participation in a 12-week
clinical trial involving open-label lurasidone treatment and is able to comply with
the protocol in the opinion of the Investigator.
Exclusion Criteria:
- Subject is considered by the investigator to be at imminent risk of suicide or injury
to self, others, or property.
- Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with
some intent to act, without specific plan) or item 5 (active suicidal ideation with
specific plan and intent) on the C-SSRS at the extension baseline visit (Study Visit
Number 42 in study D1050238). Subjects who answer "yes" to this question must be
referred by the Investigator for appropriate follow-up evaluation and treatment.
- Subject tests positive for drugs of abuse or is suspected of current alcohol abuse at
the extension baseline visit (Study Visit Number 42 in study D1050238). In the event
a subject tests positive for cannabinoids, the Investigator will evaluate the
subject's ability to abstain from cannabis during the study.
We found this trial at
42
sites
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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2725 Rebecca Lane
De Bary-Orange City, Florida 32763
De Bary-Orange City, Florida 32763
386-775-7627
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8043 Cooper Creek Boulevard
Suite 107
Bradenton, Florida 34201
Bradenton, Florida 34201
(941) 747-7900
Florida Clinical Research Center, LLC Led by Andrew J. Cutler, M.D., Florida Clinical Research Center,...
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