Clinical Trials List
2012-08-01 - 2015-08-31
Phase III
Terminated13
ICD-10F20.9
Schizophrenia, unspecified
Randomized, Double-blind, Parallel- group, Placebo-controlled, Confirmatory Study of SM-13496 (lurasidone HCl) in Patients with Schizophrenia
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Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
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Sponsor
Dainippon Sumitomo Pharma Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 王俸鋼 Division of Psychiatry
- NAN-YING CHIU Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Chen-Chung Liu Division of Psychiatry
- CHIH-MIN LIU Division of Psychiatry
- 謝明憲 Division of Psychiatry
- YI-LING CHIEN Division of Psychiatry
- YI-TING LIN Division of Psychiatry
The Actual Total Number of Participants Enrolled
7 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
a) Primary efficacy measure will be assessed by the Change from baseline in PANSS total score
b) Secondary efficacy mesures will be assessed by the Change from baseline in the PANSS total score by subscales etc.
2. Safety
Safety will be assessed by the proportion of subjects with Adverse Events (AEs), Discontinuations due to AEs, and Serious Adverse Events (SAEs).
Inclution Criteria
- Patient meets DSM-IV criteria for schizophrenia.
- Patient is aged 18 through 74 years at informed consent.
- Patient understands the objectives, procedures, and possible benefits and risks of the study and who provide written voluntarily consent to participate in the study.
Exclusion Criteria
- Patient has a history of neuroleptic malignant syndrome, water intoxication, or paralytic ileus.
- Patient has Parkinson’s disease.
- Patient has a history or complication of malignancy.
The Estimated Number of Participants
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Taiwan
225 participants
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Global
435 participants
