A 6-week Study to Evaluate the Efficacy and Safety of Lurasidone HCL in Acutely Psychotic Patients With Schizophrenia

• Status: Recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study designed to evaluate the efficacy and safety of lurasidone in acutely psychotic patients with chronic schizophrenia and to confirm the non-inferiority of lurasidone relative to quetiapine XR.

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

Details

• Lead Sponsor: Bukwang Pharmaceutical
• Treatments: Lurasidone Hydrochloride; Quetiapine Fumarate

Criteria

Inclusion Criteria:

1. Provide written informed consent and aged between 19 and 75 years of age.

2. Meets DSM-5 criteria for a primary diagnosis of schizophrenia.

3. CGI-S ≥ 4 at screening and baseline.

4. Subject is not pregnant (must have a negative serum pregnancy test at screening) or nursing (must not be lactating) and is not planning pregnancy within the projected duration of the study.

5. Subject is able and agrees to remain off prior antipsychotic medication for the duration of the study.

6. Subject is in good physical health on the basis of medical history, physical examination, and laboratory screening.

Exclusion Criteria:

1. The subject has evidence of any chronic organic disease of the CNS (other than schizophrenia)

2. Subject has participated in a prior trial of lurasidone.

3. Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.

4. In the opinion of the investigator, subject is unable to cooperate with any study procedures, unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.

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