A Clinical Trial of Lurasidone in Treatment of Schizophrenia

A Randomized, Double-blind, Double-dummy, Parallel-group and Multicenter Study to Investigate Lurasidone in Treatment of Schizophrenia Compared With Risperidone

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Lurasidone tablets; Drug: Risperidone tablets

• Study Type: Interventional
• Enrollment (Actual): 388
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100096
      • Beijing Huilongguan Hospital
    • Beijing, Beijing, China, 100191
      • Peking University Sixth Hospital
    • Beijing, Beijing, China, 100088
      • Capital Medical University Affiliated Beijing Anding Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510370
      • Guangzhou Brain Hospital
  • Hebei
    • Baoding, Hebei, China, 071000
      • Hebei Mental Health Center
  • Henan
    • Xinxiang, Henan, China, 453002
      • Henan Provincial Mental Hospital
  • Hunan
    • Changsha, Hunan, China, 410000
      • The second Xiangya Hospital of Central South University
    • Changsha, Hunan, China, 410007
      • Hunan Province Brain Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Nanjing Brain Hospital
    • Wuxi, Jiangsu, China, 214000
      • Wuxi mental health center
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Mental Health Center
  • Shanxi
    • Xi'an, Shanxi, China, 710061
      • Xi'an Mental Health Center
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China, 300222
      • Tianjin Anding Hospital
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • First Affiliated Hospital of Kunming Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lurasidone group	Drug: Lurasidone tablets; Lurasidone tablets (40or80mg/day) and Risperidone tablets(Placebo); Other Names: LATUDA
Active Comparator: Risperidone group	Drug: Risperidone tablets; Risperidone tablets(2-6mg/day) and Lurasidone tablets(Placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Scores.	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.	From baseline to Week 6(day 42).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 6.	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.	From baseline to Week 6(day 42).

Collaborators and Investigators

• Sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
• Investigators: Principal Investigator: Zhuoji CAI, MD, Capital Medical University Affiliated Beijing Anding Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: December 2, 2013
• First Submitted That Met QC Criteria: December 2, 2013
• First Posted (Estimate): December 6, 2013

Study Record Updates

• Last Update Posted (Actual): November 15, 2019
• Last Update Submitted That Met QC Criteria: November 3, 2019
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: schizophrenia; Lurasidone; LATUDA
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Adrenergic alpha-Antagonists; Adrenergic alpha-2 Receptor Antagonists; Risperidone; Lurasidone Hydrochloride
• Other Study ID Numbers: D1070004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No