Overview
Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia
Status:
Completed
Completed
Trial end date:
2010-10-01
2010-10-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
SunovionTreatments:
Lurasidone Hydrochloride
Criteria
Inclusion Criteria:To be eligible to enter the study, each patient must comply with the following 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.