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

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: 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 effective, tolerable, and safe as compared with quetiapine XR short term among acutely psychotic patients with chronic schizophrenia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion
• Treatments: Lurasidone Hydrochloride; Quetiapine Fumarate

Criteria

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.