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
30
sites
Cerritos, California 90703
15
mi
from 91732
Cerritos, CA
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Austin, Texas 78754
1215
mi
from 91732
Austin, TX
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Austin, Texas 78731
1212
mi
from 91732
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
mi
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Bradenton, FL
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Cerritos, California 90703
14
mi
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Cerritos, CA
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Costa Mesa, California 92280
195
mi
from 91732
Costa Mesa, CA
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Dallas, Texas 75243
1226
mi
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Dallas, TX
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Escondido, California 92025
86
mi
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Escondido, CA
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Flowood, Mississippi 39232
1611
mi
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Flowood, MS
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Fruitland Park, Florida 34731
2146
mi
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Fruitland Park, FL
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Garden Grove, California 92845
20
mi
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Garden Grove, CA
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Highlands Ranch, Colorado 80103
813
mi
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Highlands Ranch, CO
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Holliswood, New York 11423
2445
mi
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Holliswood, NY
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Lake Charles, Louisiana 70601
1471
mi
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Lake Charles, LA
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Little Rock, Arkansas 72201
1463
mi
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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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Long Beach, California 90813
23
mi
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Long Beach, CA
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Paramount, California 90723
15
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Paramount, CA
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Pasadena, California 91107
6
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Pasadena, CA
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Pico Rivera, California 90660
7
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Pico Rivera, CA
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Riverside, California 92506
37
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Riverside, CA
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San Diego, California 92102
106
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San Diego, CA
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Sandeigo, California 92103
103
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Sandeigo, CA
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Shreveport, Louisiana 71104
1403
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Shreveport, LA
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St Charles, Missouri 63301
1557
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St Charles, MO
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St. Louis, Missouri 63118
1570
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St. Louis, MO
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8732
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Vijayawada,
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Washington, District of Columbia 20016
2278
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Washington,
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Willingboro, New Jersey 08046
2389
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Willingboro, NJ
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Winston-Salem, North Carolina 27104
2122
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Winston-Salem, NC
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