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 |
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.
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
8043 Cooper Creek Boulevard
Suite 107
Bradenton, Florida 34201
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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