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

Use our guide to learn which trials are right for you!

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
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
2725 Rebecca Lane
De Bary-Orange City, Florida 32763
386-775-7627
?
mi
from
De Bary-Orange City, FL
Click here to add this to my saved trials
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...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30328
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Austin, Texas 78756
?
mi
from
Austin, TX
Click here to add this to my saved trials
Austin, Texas 78754
?
mi
from
Austin, TX
Click here to add this to my saved trials
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,...
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
Buffalo, New York 14215
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
Cedarhurst, New York 11516
?
mi
from
Cedarhurst, NY
Click here to add this to my saved trials
Cerritos, California 90703
?
mi
from
Cerritos, CA
Click here to add this to my saved trials
Dallas, Texas 75243
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75231
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Downey, California 90241
?
mi
from
Downey, CA
Click here to add this to my saved trials
Fresh Meadows, New York 11366
?
mi
from
Fresh Meadows, NY
Click here to add this to my saved trials
Garden Grove, California 92845
?
mi
from
Garden Grove, CA
Click here to add this to my saved trials
Kissimmee, Florida 34741
?
mi
from
Kissimmee, FL
Click here to add this to my saved trials
Lake Charles, Louisiana 70601
?
mi
from
Lake Charles, LA
Click here to add this to my saved trials
Las Vegas, Nevada 89102
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lincoln, Rhode Island 02865
?
mi
from
Lincoln, RI
Click here to add this to my saved trials
Little Rock, Arkansas 72201
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Little Rock, Arkansas 72211
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Los Angeles, California 90036
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Miami Springs, Florida 33166
?
mi
from
Miami Springs, FL
Click here to add this to my saved trials
National City, California 91950
?
mi
from
National City, CA
Click here to add this to my saved trials
O'Fallon, Missouri 63368
?
mi
from
O'Fallon, MO
Click here to add this to my saved trials
Oceanside, California 92056
?
mi
from
Oceanside, CA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73116
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73116
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19139
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Pico Rivera, California 90660
?
mi
from
Pico Rivera, CA
Click here to add this to my saved trials
Rochester, New York 14618
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Rockville, Maryland 20850
?
mi
from
Rockville, MD
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Shreveport, Louisiana 71104
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
Spokane, Washington 99204
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Springdale, Arizona 72764
?
mi
from
Springdale, AZ
Click here to add this to my saved trials
St. Louis, Missouri 63128
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
Staten Island, New York 10305
?
mi
from
Staten Island, NY
Click here to add this to my saved trials
The Woodlands, Texas 77381
?
mi
from
The Woodlands, TX
Click here to add this to my saved trials
Torrance, California 90502
?
mi
from
Torrance, CA
Click here to add this to my saved trials
Willingboro, New Jersey 08046
?
mi
from
Willingboro, NJ
Click here to add this to my saved trials