Back to resultsA 6-week Study to Evaluate the Efficacy and Safety of Lurasidone HCL in Acutely Psychotic Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lurasidone HCL 160 mg
Quetiapine XR 600 mg
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Acutely Psychotic Patients with Schizophrenia, Latuda, Lurasidone
Eligibility Criteria
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.
Sites / Locations
- Borame Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lurasidone HCL 160 mg
Quetiapine XR 600 mg
Arm Description
Lurasidone HCL 160 mg/day
Quetiapine XR 600 mg/day
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03465787
Brief Title
A 6-week Study to Evaluate the Efficacy and Safety of Lurasidone HCL in Acutely Psychotic Patients With Schizophrenia
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 9, 2018 (Actual)
Primary Completion Date
October 26, 2022 (Actual)
Study Completion Date
October 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bukwang Pharmaceutical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Acutely Psychotic Patients with Schizophrenia, Latuda, Lurasidone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lurasidone HCL 160 mg
Arm Type
Experimental
Arm Description
Lurasidone HCL 160 mg/day
Arm Title
Quetiapine XR 600 mg
Arm Type
Active Comparator
Arm Description
Quetiapine XR 600 mg/day
Intervention Type
Drug
Intervention Name(s)
Lurasidone HCL 160 mg
Intervention Description
Lurasidone HCL 2 80mg tablets, QD
Intervention Type
Drug
Intervention Name(s)
Quetiapine XR 600 mg
Intervention Description
Quetiapine XR 2 300 mg tablets, QD
Primary Outcome Measure Information:
Title
Mean change in Total PANSS Score From Baseline at Week 6
Description
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.
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Mean change in CGI-S score From Baseline at Week 6
Description
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).
Time Frame
Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung Hee Yeon
Organizational Affiliation
SMG-SNU Boramae Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Borame Medical Center
City
Seoul
State/Province
Seoul, Dongjak-gu
ZIP/Postal Code
07061
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A 6-week Study to Evaluate the Efficacy and Safety of Lurasidone HCL in Acutely Psychotic Patients With Schizophrenia
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