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Completed

NCT Number: NCT03465787

A 6-week Study to Evaluate the Efficacy and Safety of Lurasidone HCL 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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Borame Medical Center

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lurasidone HCL 160 mg

Drug

Lurasidone HCL 2 80mg tablets, QD

Quetiapine XR 600 mg

Drug

Quetiapine XR 2 300 mg tablets, QD

Primary outcomes

  1. Mean change in Total PANSS Score From Baseline at Week 6

    Time frame: 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 outcomes

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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Bukwang Pharmaceutical

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 14, 2018
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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