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

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Lurasidone HCL 160 mg; Drug: Quetiapine XR 600 mg

• Registration Number: NCT03465787
• Lead Sponsor: Bukwang Pharmaceutical

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-08
• Study First Submitted QC: 2018-03-08
• Study First Posted: 2018-03-14
• Study Start: 2018-04-09
• Primary Completion: 2022-10-26
• Study Completion: 2022-10-26
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lurasidone HCL 160 mg	Lurasidone HCL 160 mg	Lurasidone HCL 160 mg/day
Quetiapine XR 600 mg	Quetiapine XR 600 mg	Quetiapine XR 600 mg/day

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (1)

Borame Medical Center; 🇰🇷 Seoul, Seoul, Dongjak-gu, Korea, Republic of