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

Bukwang Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Schizophrenia

Treatments

Drug: Quetiapine XR 600 mg

Drug: Lurasidone HCL 160 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT03465787

BK-LuD-301

Details and patient eligibility

About

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.

Enrollment

210 patients

Sex

All

Ages

19 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provide written informed consent and aged between 19 and 75 years of age.
Meets DSM-5 criteria for a primary diagnosis of schizophrenia.
CGI-S ≥ 4 at screening and baseline.
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.
Subject is able and agrees to remain off prior antipsychotic medication for the duration of the study.
Subject is in good physical health on the basis of medical history, physical examination, and laboratory screening.

Exclusion criteria

The subject has evidence of any chronic organic disease of the CNS (other than schizophrenia)
Subject has participated in a prior trial of lurasidone.
Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
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.
Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.