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

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Lurasidone HCL 160 mg; Drug: Quetiapine XR 600 mg

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Dongjak-gu
    • Seoul, Seoul, Dongjak-gu, Korea, Republic of, 07061
      • Borame Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bukwang Pharmaceutical
• Investigators: Principal Investigator: Jung Hee Yeon, SMG-SNU Boramae Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 9, 2018
• Primary Completion (ACTUAL): October 26, 2022
• Study Completion (ACTUAL): October 26, 2022

Study Registration Dates

• First Submitted: March 8, 2018
• First Submitted That Met QC Criteria: March 8, 2018
• First Posted (ACTUAL): March 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Schizophrenia; Lurasidone; Latuda; Acutely Psychotic Patients with Schizophrenia
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Adrenergic alpha-Antagonists; Adrenergic alpha-2 Receptor Antagonists; Quetiapine Fumarate; Lurasidone Hydrochloride
• Other Study ID Numbers: BK-LuD-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No