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Sumitomo Pharma (Suzhou) Co., Ltd.A Clinical Trial of Lurasidone in Treatment of Schizophrenia Phase 3 388 Randomized Double-Blind
Clinical Trial NCT02002832 was designed to study Treatment for Schizophrenia. This was a Phase 3 interventional study that is now completed. The study started on December 1, 2013, with plans to enroll 388 participants. Led by Sumitomo Pharma (Suzhou) Co., Ltd., the expected completion date was November 1, 2015. The latest data from ClinicalTrials.gov was last updated on November 15, 2019.
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.
Official Title
A Randomized, Double-blind, Double-dummy, Parallel-group and Multicenter Study to Investigate Lurasidone in Treatment of Schizophrenia Compared With Risperidone
Conditions
SchizophreniaOther Study IDs
- D1070004
NCT ID Number
Start Date (Actual)
2013-12
Last Update Posted
2019-11-15
Completion Date (Estimated)
2015-11
Enrollment (Estimated)
388
Study Type
Interventional
PHASE
Phase 3
Status
Completed
Keywords
schizophrenia
Lurasidone
LATUDA
Lurasidone
LATUDA
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalLurasidone group | Lurasidone tablets Lurasidone tablets (40or80mg/day) and Risperidone tablets(Placebo) |
Active ComparatorRisperidone group | Risperidone tablets Risperidone tablets(2-6mg/day) and Lurasidone tablets(Placebo) |
Primary Outcome Measures
Secondary 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). |
| 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). |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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.
Sumitomo Pharma (Suzhou) Co., Ltd.No contact data.
15 Study Locations in 1 Countries
Beijing Municipality
Capital Medical University Affiliated Beijing Anding Hospital, Beijing, Beijing Municipality, 100088, China
Beijing Huilongguan Hospital, Beijing, Beijing Municipality, 100096, China
Peking University Sixth Hospital, Beijing, Beijing Municipality, 100191, China
Guangdong
Guangzhou Brain Hospital, Guangzhou, Guangdong, 510370, China
Hebei
HeBei Mental Health Center, Baoding, Hebei, 071000, China
Henan
Henan Provincial Mental Hospital, Xinxiang, Henan, 453002, China
Hunan
The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410000, China
Hunan Province Brain Hospital, Changsha, Hunan, 410007, China
Jiangsu
Nanjing Brain Hospital, Nanjing, Jiangsu, 210029, China
Wuxi Mental Health Center, Wuxi, Jiangsu, 214000, China
Shanghai Municipality
Shanghai Mental Health Center, Shanghai, Shanghai Municipality, 200030, China
Shanxi
Xi'an Mental Health Center, Xi’an, Shanxi, 710061, China
Sichuan
West China Hospital, Sichuan University, Chengdu, Sichuan, 610041, China
Tianjin Municipality
Tianjin Anding Hospital, Tianjin, Tianjin Municipality, 300222, China
Yunnan
First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, 650032, China