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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03465787
• Other study ID #: BK-LuD-301
• Status: Completed
• Phase: Phase 3
• Start date: April 9, 2018
• Est. completion date: October 26, 2022

Study information

• Verified date: February 2023
• Source: Bukwang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: October 26, 2022
• Est. primary completion date: October 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Schizophrenia

Intervention

Drug:
• Lurasidone HCL 160 mg
Lurasidone HCL 2 80mg tablets, QD
• Quetiapine XR 600 mg
Quetiapine XR 2 300 mg tablets, QD

Locations

Country	Name	City	State
Korea, Republic of	Borame Medical Center	Seoul	Seoul, Dongjak-gu

Sponsors (1)

Lead Sponsor	Collaborator
Bukwang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in Total PANSS Score From Baseline at 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.	Week 6
Secondary	Mean change in CGI-S score From Baseline at 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).	Week 6