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
O'Fallon, Missouri 63368
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2725 Rebecca Lane
De Bary-Orange City, Florida 32763
386-775-7627
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De Bary-Orange City, FL
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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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Atlanta, GA
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Atlanta, Georgia 30328
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Austin, Texas 78756
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Austin, TX
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Austin, Texas 78754
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Austin, TX
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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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Bradenton, FL
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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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Oceanside, California 92056
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Oklahoma City, Oklahoma 73116
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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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Rockville, MD
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Salt Lake City, UT
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San Diego, CA
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Santa Ana, CA
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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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Torrance, California 90502
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Willingboro, New Jersey 08046
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