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

Sponsor

Bukwang Pharmaceutical (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03465787

Collaborator

(none)

210

Enrollment

Location

Arms

54.8

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Lurasidone HCL 160 mg Drug: Quetiapine XR 600 mg	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase 3 Randomized, Double-Blind, Active-controlled Study to Evaluate the Efficacy and Safety of Lurasidone in Acutely Psychotic Patients With Schizophrenia

Actual Study Start Date :

Apr 9, 2018

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lurasidone HCL 160 mg Lurasidone HCL 160 mg/day	Drug: Lurasidone HCL 160 mg Lurasidone HCL 2 80mg tablets, QD
Active Comparator: Quetiapine XR 600 mg Quetiapine XR 600 mg/day	Drug: Quetiapine XR 600 mg Quetiapine XR 2 300 mg tablets, QD

Arm

Intervention/Treatment

Experimental: Lurasidone HCL 160 mg

Lurasidone HCL 160 mg/day

Drug: Lurasidone HCL 160 mg

Lurasidone HCL 2 80mg tablets, QD

Active Comparator: Quetiapine XR 600 mg

Quetiapine XR 600 mg/day

Drug: Quetiapine XR 600 mg

Quetiapine XR 2 300 mg tablets, QD

Outcome Measures

Primary Outcome Measures

Mean change in Total PANSS Score From Baseline at Week 6 [Week 6]
The PANSS (Positive and Negative Syndrome Scale) is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.

Secondary Outcome Measures

Mean change in CGI-S score From Baseline at Week 6 [Week 6]
Clinical Global Impression of Severity is a clinician-rated assessment of the subject's current illness state on a 7 point scale, where a higher score is associated with greater illness severity. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill).

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.