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

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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
811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
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
386-775-7627
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Atlanta, Georgia 30328
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Austin, Texas 78756
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Austin, Texas 78754
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8043 Cooper Creek Boulevard Suite 107
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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Buffalo, New York 14215
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Cedarhurst, New York 11516
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Cerritos, California 90703
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Dallas, Texas 75243
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Dallas, Texas 75231
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Downey, California 90241
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Fresh Meadows, New York 11366
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Garden Grove, California 92845
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Kissimmee, Florida 34741
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Lake Charles, Louisiana 70601
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Las Vegas, Nevada 89102
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Lincoln, Rhode Island 02865
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Little Rock, Arkansas 72201
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Little Rock, Arkansas 72211
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Los Angeles, California 90036
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Miami Springs, Florida 33166
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National City, California 91950
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O'Fallon, Missouri 63368
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Oceanside, California 92056
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Oklahoma City, Oklahoma 73116
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Philadelphia, Pennsylvania 19139
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Pico Rivera, California 90660
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Rochester, New York 14618
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Rockville, Maryland 20850
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Shreveport, Louisiana 71104
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Spokane, Washington 99204
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Springdale, Arizona 72764
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St. Louis, Missouri 63128
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Staten Island, New York 10305
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The Woodlands, Texas 77381
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Willingboro, New Jersey 08046
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