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
Garden Grove, California 92845
20
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Garden Grove, CA
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2725 Rebecca Lane
De Bary-Orange City, Florida 32763
386-775-7627
2180
mi
from 91732
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...
1919
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Atlanta, GA
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Atlanta, Georgia 30328
1917
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Atlanta, GA
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Austin, Texas 78756
1211
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Austin, TX
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Austin, Texas 78754
1215
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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,...
2143
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Bradenton, FL
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Buffalo, New York 14215
2180
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Buffalo, NY
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Cedarhurst, New York 11516
2447
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Cedarhurst, NY
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Cerritos, California 90703
14
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Cerritos, CA
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Dallas, Texas 75243
1226
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Dallas, TX
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Dallas, Texas 75231
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Dallas, TX
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Downey, California 90241
11
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Downey, CA
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Fresh Meadows, New York 11366
2444
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Fresh Meadows, NY
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Kissimmee, Florida 34741
2187
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Kissimmee, FL
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Lake Charles, Louisiana 70601
1471
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Lake Charles, LA
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Las Vegas, Nevada 89102
217
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Las Vegas, NV
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Lincoln, Rhode Island 02865
2560
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Lincoln, RI
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Little Rock, Arkansas 72201
1463
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Little Rock, AR
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Little Rock, Arkansas 72211
1463
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Little Rock, AR
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Los Angeles, California 90036
19
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Los Angeles, CA
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Miami Springs, Florida 33166
2314
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Miami Springs, FL
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National City, California 91950
110
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National City, CA
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O'Fallon, Missouri 63368
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O'Fallon, MO
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Oceanside, California 92056
73
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Oceanside, CA
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Oklahoma City, Oklahoma 73116
1164
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Oklahoma City, OK
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Oklahoma City, Oklahoma 73116
1162
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Oklahoma City, OK
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Philadelphia, Pennsylvania 19139
2375
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Philadelphia, PA
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Pico Rivera, California 90660
7
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Pico Rivera, CA
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Rochester, New York 14618
2248
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Rochester, NY
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Rockville, Maryland 20850
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Rockville, MD
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570
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Salt Lake City, UT
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105
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San Diego, CA
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24
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Santa Ana, CA
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Shreveport, Louisiana 71104
1402
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Shreveport, LA
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Spokane, Washington 99204
938
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Spokane, WA
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Springdale, Arizona 72764
347
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Springdale, AZ
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St. Louis, Missouri 63128
1563
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St. Louis, MO
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Staten Island, New York 10305
2429
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Staten Island, NY
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The Woodlands, Texas 77381
1344
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The Woodlands, TX
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Torrance, California 90502
22
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Torrance, CA
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Willingboro, New Jersey 08046
2389
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Willingboro, NJ
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