Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute Schizophrenia.



Status:Completed
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:October 2008
End Date:July 2010

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A Phase 3 Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of Two Doses of Lurasidone in Acutely Psychotic Subjects With Schizophrenia (PEARL 3)

Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This
clinical study is designed to test the hypothesis that lurasidone is effective, tolerable,
and safe as compared with quetiapine XR short term among acutely psychotic patients with
chronic schizophrenia.


Inclusion Criteria:

- Provide written informed consent and aged between 18 and 75 years of age.

- Meets DSM-IV™ criteria for a primary diagnosis of schizophrenia.

- Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate
and reliable contraception for duration of study.

- Able and agrees to remain off prior antipsychotic medication for the duration of
study.

- Good physical health on the basis of medical history, physical examination, and
laboratory screening.

- Willing and able to comply with the protocol, including the inpatient requirements
and outpatient visits.

Exclusion Criteria:

- Considered by the investigator to be at imminent risk of suicide or injury to self,
others, or property.

- Any chronic organic disease of the CNS (other than schizophrenia).

- Used investigational compound within 30 days.

- Clinically significant or history of alcohol abuse/alcoholism or drug
abuse/dependence within the last 6 months.
We found this trial at
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Little Rock, Arkansas 72201
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Austin, Texas 78754
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Austin, Texas 78731
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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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Cerritos, California 90703
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Cerritos, California 90703
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Costa Mesa, California 92280
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Dallas, Texas 75243
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Escondido, California 92025
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Flowood, Mississippi 39232
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Fruitland Park, Florida 34731
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Garden Grove, California 92845
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Highlands Ranch, Colorado 80103
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Holliswood, New York 11423
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Lake Charles, Louisiana 70601
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Little Rock, Arkansas 72211
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Long Beach, California 90813
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Paramount, California 90723
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Pasadena, California 91107
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Pico Rivera, California 90660
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Riverside, California 92506
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San Diego, California 92102
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Sandeigo, California 92103
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Shreveport, Louisiana 71104
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St Charles, Missouri 63301
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St. Louis, Missouri 63118
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Vijayawada,
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Washington, District of Columbia 20016
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Willingboro, New Jersey 08046
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Winston-Salem, North Carolina 27104
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