A Clinical Trial of Lurasidone in Treatment of Schizophrenia

NCT02002832 | Completed Phase 3 Results

• 1 other identifier: D1070004
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 15

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.

Conditions

Schizophrenia

Keywords

schizophrenia; Lurasidone; LATUDA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 6.

  From baseline to Week 6(day 42).

Study Arms (2)

Lurasidone group

EXPERIMENTAL

Drug: Lurasidone tablets

Risperidone group

ACTIVE COMPARATOR

Drug: Risperidone tablets

Interventions

Lurasidone tablets DRUG

Lurasidone tablets (40or80mg/day) and Risperidone tablets(Placebo)

Also known as: LATUDA

Lurasidone group

Risperidone tablets DRUG

Risperidone tablets(2-6mg/day) and Lurasidone tablets(Placebo)

Risperidone group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sumitomo Pharma (Suzhou) Co., Ltd.: lead

Study Sites (15)

Capital Medical University Affiliated Beijing Anding Hospital

Beijing, Beijing Municipality, 100088, China

Location

Beijing Huilongguan Hospital

Beijing, Beijing Municipality, 100096, China

Location

Peking University Sixth Hospital

Beijing, Beijing Municipality, 100191, China

Location

Guangzhou Brain Hospital

Guangzhou, Guangdong, 510370, China

Location

HeBei Mental Health Center

Baoding, Hebei, 071000, China

Location

Henan Provincial Mental Hospital

Xinxiang, Henan, 453002, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

Location

Hunan Province Brain Hospital

Changsha, Hunan, 410007, China

Location

Nanjing Brain Hospital

Nanjing, Jiangsu, 210029, China

Location

Wuxi Mental Health Center

Wuxi, Jiangsu, 214000, China

Location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

Xi'an Mental Health Center

Xi’an, Shanxi, 710061, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Tianjin Anding Hospital

Tianjin, Tianjin Municipality, 300222, China

Location

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Lurasidone Hydrochloride; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrimidinones; Pyrimidines

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Sumitomo Pharma (Suzhou) Co., Ltd.

luo@dsmpharm.com.cn

+86-10-57322070

Study Officials

• Zhuoji CAI, MD

  Capital Medical University Affiliated Beijing Anding Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 6, 2013
• Study Start: December 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 15, 2019
• Results First Posted: April 1, 2019

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)