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

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ClinicalTrials.gov Identifier: NCT03465787
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Lurasidone HCL 160 mg Drug: Quetiapine XR 600 mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 9, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : April 2019


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




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03465787


Contacts
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Contact: Kwon Bong Ju 82-2-828-8082 bong.ju.kwon@bukwang.co.kr

Locations
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Korea, Republic of
Borame Medical Center Recruiting
Seoul, Seoul, Dongjak-gu, Korea, Republic of, 07061
Contact: Jung Hee Yeon    82-2-870-2461    hyjung@snu.ac.kr   
Principal Investigator: Jung Hee Yeon, M.D.         
Sponsors and Collaborators
Bukwang Pharmaceutical
Investigators
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Principal Investigator: Jung Hee Yeon SMG-SNU Boramae Medical Center

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Responsible Party: Bukwang Pharmaceutical
ClinicalTrials.gov Identifier: NCT03465787     History of Changes
Other Study ID Numbers: BK-LuD-301
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bukwang Pharmaceutical:
Schizophrenia
Acutely Psychotic Patients with Schizophrenia
Latuda
Lurasidone

Additional relevant MeSH terms:
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Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Schizophrenia
Quetiapine Fumarate
Lurasidone Hydrochloride
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents