Pediatric Open-Label Extension Study



Status:Completed
Conditions:Depression, Depression, Schizophrenia, Neurology, Psychiatric, Psychiatric, Autism
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:6 - 17
Updated:12/9/2018
Start Date:September 30, 2013
End Date:October 17, 2018

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A 104-Week, Flexible-Dose, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Effectiveness of Lurasidone in Pediatric Subjects

This is an open-label, 104-week, multicenter, extension study designed to evaluate the
long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or
80 mg/day) in pediatric subjects who have completed the 6-week treatment period in the
preceding studies, D1050301, D1050325, and D1050326


Inclusion Criteria:

- Written informed consent from parent(s) or legal guardian(s) with sufficient
intellectual capacity to understand the study and support subjects' participation in
the study procedures must be obtained for subjects who are not emancipated. In
accordance with Institutional Review Board (IRB) or Independent Ethics Committee (IEC)
requirements, the subject will complete an informed assent when developmentally
appropriate, to participate in the study before conduct of any study-specific
procedures.

- Subject has completed Study D1050301 (Visit 9) OR

- Subject has completed Study D1050325 (Visit 9) OR

- Subject has completed Study D1050326 (Visit 8)

- Subject is judged by the investigator to be appropriate for participation in a
104-week clinical trial in an outpatient setting involving open-label lurasidone
treatment, and is able to comply with the protocol.

- A reliable informant (eg, parent, legal guardian, or caregiver) must be available to
accompany the subject at each visit. For subjects entering from Study D1050325, the
reliable caregiver must also oversee the administration of the study drug throughout
the study

- Females who participate in this study:

- are unable to become pregnant (eg, premenarchal, surgically sterile, etc.) -OR-

- practices true abstinence (consistent with lifestyle) and must agree to remain
abstinent from signing informed consent to at least 7 days after the last dose of
study drug has been taken; -OR-

- are sexually active and willing to use a medically effective method of birth
control (eg, male using condom and female using condom, diaphragm, contraceptive
sponge, spermicide, contraceptive pill, or intrauterine device) from signing
informed consent to at least 7 days after the last dose of study drug has been
taken.

- Males must be willing to remain sexually abstinent (consistent with lifestyle) or use
an effective method of birth control (eg, male using condom and female using condom,
diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine
device) from signing informed consent to at least 7 days after the last dose of study
drug has been taken.

Exclusion Criteria:

- Subject is considered by the investigator to be at imminent risk of suicide.

- Exhibits evidence of moderate or severe extrapyramidal symptoms, dystonia, tardive
dyskinesia, or any other moderate or severe movement disorder. Severity to be
determined by the investigator.
We found this trial at
37
sites
707 North Broadway
Baltimore, Maryland 21205
443-923-9200
Principal Investigator: Robert Findling, MD
Phone: 443-923-7620
Kennedy Krieger Institute While not officially part of Johns Hopkins Medicine, Kennedy Krieger Institute is...
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Baltimore, MD
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234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
Principal Investigator: Melissa DelBello, MD
Phone: 513-245-3415
University of Cincinnati Medical Center Opening in 1823 as the country
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Principal Investigator: Robert Reisenberg, MD
Phone: 404-881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Bloomfield Hills, Michigan 48302
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Vishal Madaan, MD
Phone: 434-243-6950
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Cleveland, Ohio 44194
Principal Investigator: Nora McNamara, MD
Phone: 216-844-5295
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Clinton, Utah 84015
Principal Investigator: Samantha Bostrom, MD
Phone: 801-614-5501
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Dallas, Texas 75243
Principal Investigator: Scott Bartley, MD
Phone: 214-388-6455
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Dothan, Alabama 36303
Principal Investigator: Nelson Handel, MD
Phone: 334-836-2000
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Downey, California 90241
Principal Investigator: Elizabeth Zarate-Powell, MD
Phone: 562-622-0700
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Gainesville, Florida 32607
Principal Investigator: Elias Sarkis, MD
Phone: 352-333-0094
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Glen Oaks, New York 11004
Principal Investigator: Vivian Kafantares, MD
Phone: 718-470-3503
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Herndon, Virginia 20170
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Lake Charles, Louisiana 70601
Principal Investigator: Kasinath G Yadalam, MD
Phone: 337-494-3266
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Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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359 East Main Street
Mount Kisco, New York 10549
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Neptune, New Jersey 07754
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New York, New York 10467
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Oklahoma City, Oklahoma 73116
Principal Investigator: Willis Holloway, MD
Phone: 405-603-8068
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Orlando, Florida 32806
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Orlando, Florida 32803
Principal Investigator: Morteza Nadjafi, MD
Phone: 407-423-7149
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Overland Park, Kansas 66211
Principal Investigator: William Murphy, MD
Phone: 913-438-8221
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Petersburg, Virginia 23805
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Roanoke, Virginia
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Rochester, New York 14618
Principal Investigator: Sarah Atkinson, MD
Phone: 585-241-9670
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Ruse,
Principal Investigator: Bilyana Mechkunova, MD
Phone: +359878435022
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4801 Weldon Spring Parkway
Saint Charles, Missouri 63301
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Saint Petersburg, Florida 33701
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505 Parnassus Ave
San Francisco, California 94143
(415) 476-1000
University of California, San Francisco Medical Center UCSF Medical Center is recognized throughout the world...
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505 Parnassus Ave
San Francisco, California 94143
(415) 476-1000
University of California, San Francisco Medical Center UCSF Medical Center is recognized throughout the world...
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Sanford, Florida 32771
Principal Investigator: Adly Thebaud, MD
Phone: 386-775-7627
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Santa Ana, California 92701
Principal Investigator: Daniel Chueh, MD
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Smyrna, Georgia 30080
Principal Investigator: Ashraf Attalla, MD
Phone: 770-319-8025
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Staten Island, New York 10312
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The Woodlands, Texas 77381
Principal Investigator: Marshall Lucas, MD
Phone: 281-367-1015
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