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

NCT03465787 | Completed Phase 3

• 1 other identifier: BK-LuD-301
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Acutely Psychotic Patients with Schizophrenia; Latuda; Lurasidone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean change in CGI-S score From Baseline at Week 6

  Week 6

Study Arms (2)

Lurasidone HCL 160 mg

EXPERIMENTAL

Lurasidone HCL 160 mg/day

Drug: Lurasidone HCL 160 mg

Quetiapine XR 600 mg

ACTIVE COMPARATOR

Quetiapine XR 600 mg/day

Drug: Quetiapine XR 600 mg

Interventions

Lurasidone HCL 160 mg DRUG

Lurasidone HCL 2 80mg tablets, QD

Lurasidone HCL 160 mg

Quetiapine XR 600 mg DRUG

Quetiapine XR 2 300 mg tablets, QD

Quetiapine XR 600 mg

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bukwang Pharmaceutical: lead

Study Sites (1)

Borame Medical Center

Seoul, Seoul, Dongjak-gu, 07061, South Korea

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jung Hee Yeon

  SMG-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 14, 2018
• Study Start: April 9, 2018
• Primary Completion: October 26, 2022
• Study Completion: October 26, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

KR (1)