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CompletedNCT03465787Updated Feb 8, 2023

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

A Phase 3 interventional study of Lurasidone HCL 160 mg and Quetiapine XR 600 mg in Schizophrenia, sponsored by Bukwang Pharmaceutical. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-02-08.

Sponsored by Bukwang Pharmaceutical · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
19 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Schizophrenia

Keywords

  • Schizophrenia
  • Acutely Psychotic Patients with Schizophrenia
  • Latuda
  • Lurasidone
03

Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
210 participants (actual)

Study arms

  • Experimental
    Lurasidone HCL 160 mg

    Lurasidone HCL 160 mg/day

    Drug: Lurasidone HCL 160 mg

  • Active comparator
    Quetiapine XR 600 mg

    Quetiapine XR 600 mg/day

    Drug: Quetiapine XR 600 mg

Interventions

  • DrugLurasidone HCL 160 mg

    Lurasidone HCL 2 80mg tablets, QD

  • DrugQuetiapine XR 600 mg

    Quetiapine XR 2 300 mg tablets, QD

05

What researchers measure

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.

    Time frame: Week 6

Secondary outcomes

  1. 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).

    Time frame: Week 6

06

Study locations

1 site
  • Borame Medical Center
    Seoul, Seoul, Dongjak-gu 07061, Korea, Republic of
07

Registry details

Key details

Study ID
NCT03465787
Lead sponsor
Bukwang Pharmaceutical
Responsible party
Sponsor
First posted
Mar 14, 2018
Start date
Apr 9, 2018
Primary completion
Oct 26, 2022
Completion
Oct 26, 2022
Last update
Feb 8, 2023

Study contacts

Jung Hee Yeon
principal investigator · SMG-SNU Boramae Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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