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A Clinical Trial of Lurasidone in Treatment of Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02002832
Recruitment Status : Completed
First Posted : December 6, 2013
Results First Posted : April 1, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.

Brief Summary:
This is a randomized, double-blind, double-dummy, parallel- controlled, adjustable dose, non-inferiority and multicentre study designed to evaluate the efficacy and safety of lurasidone on schizophrenia for 6 weeks treatment, and to compare with risperidone.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Lurasidone tablets Drug: Risperidone tablets Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 388 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Double-dummy, Parallel-group and Multicenter Study to Investigate Lurasidone in Treatment of Schizophrenia Compared With Risperidone
Study Start Date : December 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Lurasidone group Drug: Lurasidone tablets
Lurasidone tablets (40or80mg/day) and Risperidone tablets(Placebo)
Other Name: LATUDA

Active Comparator: Risperidone group Drug: Risperidone tablets
Risperidone tablets(2-6mg/day) and Lurasidone tablets(Placebo)




Primary Outcome Measures :
  1. Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Scores. [ Time Frame: From baseline to Week 6(day 42). ]
    Mean change in Positive and Negative Syndrome Scale total score from baseline to Week 6 at the end of treatment. PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. It have 30 evaluation items, which include 7 positive sub-scale, 7 negative sub-scale and 16 general psychopathology sub-scale on a score of 1 to 7. The total score is the sum of the 30 scale items. The minimum score is 30 and the maximum score is 210. Patient with PANSS total scores<70 is the normal,but the scores>120 is more serious.


Secondary Outcome Measures :
  1. Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 6. [ Time Frame: From baseline to Week 6(day 42). ]

    The Clinical Global Impression Scale-Improvement (CGI-I) Score is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to baseline state at the beginning of the intervention. Response is rated as one of the following, in which higher scores indicate less improvement or worsening:

    1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provide written informed consent and aged between 18 and 65 years of age.
  • Meets DSM-IV-TR criteria for a primary diagnosis of schizophrenia, had a PANSS total score ≥ 70 and ≤ 120 at Screening and Baseline, and a score ≥ 4 on the CGI-S at Screening and Baseline.
  • Not pregnant, if of reproductive potential agrees to use adequate and reliable contraception for duration of study.
  • Able and agrees to remain off prior antipsychotic medication for the duration of study.
  • Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.

Exclusion Criteria:

  • Considered by the investigator to be at imminent risk of suicide or injury to self, others or property.
  • Any chronic organic disease of the CNS(other than schizophrenia)
  • Subjects are participating or participated in other clinical studies including marketed drugs or medical devices within 30 days before signing the informed consent form.
  • Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.

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): NCT02002832


Locations
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China, Beijing
Capital Medical University Affiliated Beijing Anding Hospital
Beijing, Beijing, China, 100088
Beijing Huilongguan Hospital
Beijing, Beijing, China, 100096
Peking University Sixth Hospital
Beijing, Beijing, China, 100191
China, Guangdong
Guangzhou Brain Hospital
Guangzhou, Guangdong, China, 510370
China, Hebei
HeBei Mental Health Center
Baoding, Hebei, China, 071000
China, Henan
Henan Provincial Mental Hospital
Xinxiang, Henan, China, 453002
China, Hunan
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410000
Hunan Province Brain Hospital
Changsha, Hunan, China, 410007
China, Jiangsu
Nanjing Brain Hospital
Nanjing, Jiangsu, China, 210029
Wuxi Mental Health Center
Wuxi, Jiangsu, China, 214000
China, Shanghai
Shanghai Mental Health Center
Shanghai, Shanghai, China, 200030
China, Shanxi
Xi'an Mental Health Center
Xi'an, Shanxi, China, 710061
China, Sichuan
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
China, Tianjin
Tianjin Anding Hospital
Tianjin, Tianjin, China, 300222
China, Yunnan
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650032
Sponsors and Collaborators
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
Investigators
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Principal Investigator: Zhuoji CAI, MD Capital Medical University Affiliated Beijing Anding Hospital
Additional Information:

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Responsible Party: Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier: NCT02002832    
Other Study ID Numbers: D1070004
First Posted: December 6, 2013    Key Record Dates
Results First Posted: April 1, 2019
Last Update Posted: November 15, 2019
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sumitomo Pharmaceutical (Suzhou) Co., Ltd.:
schizophrenia
Lurasidone
LATUDA
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Lurasidone Hydrochloride
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Serotonin 5-HT2 Receptor Antagonists
Dopamine D2 Receptor Antagonists