Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Phase III Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Sumitomo Dainippon Pharma Co., Ltd.
Information provided by (Responsible Party):
Sumitomo Dainippon Pharma Co., Ltd. Identifier:
First received: June 6, 2012
Last updated: June 4, 2014
Last verified: June 2014

The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with schizophrenia.

Condition Intervention Phase
Drug: SM-13496 40mg
Drug: SM-13496 80mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Parallel- Group, Placebo-controlled, Confirmatory Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia <Phase 3>

Resource links provided by NLM:

Further study details as provided by Sumitomo Dainippon Pharma Co., Ltd.:

Primary Outcome Measures:
  • Change from baseline in PANSS total score [ Time Frame: Change from baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 435
Study Start Date: June 2012
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SM-13496 40mg Drug: SM-13496 40mg
once daily orally
Experimental: SM-13496 80mg Drug: SM-13496 80mg
once daily orally
Placebo Comparator: Placebo Drug: Placebo
once daily orally


Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient meets DSM-IV-TR 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01614899

Contact: Dainippon Sumitomo Pharma Co., Ltd. Japan

55 Sites Recruiting
Tokyo, etc, Japan
Contact: See central contact details         
Principal Investigator: Docter Site         
Korea, Republic of
14 Sites Recruiting
Seoul, etc, Korea, Republic of
Contact: See central contact details         
Principal Investigator: Docter Site         
8 Sites Recruiting
Kuala Lumpur, etc, Malaysia
Principal Investigator: Docter Site         
12 Sites Recruiting
Taipei, etc, Taiwan
Contact: See central contact details         
Principal Investigator: Doctor Site         
Sponsors and Collaborators
Sumitomo Dainippon Pharma Co., Ltd.
Study Director: Clinical Development Drug development Division Sumitomo Dainippon Pharma Co., Ltd.
  More Information

No publications provided

Responsible Party: Sumitomo Dainippon Pharma Co., Ltd. Identifier: NCT01614899     History of Changes
Other Study ID Numbers: D1001056
Study First Received: June 6, 2012
Last Updated: June 4, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Mental Disorders
Schizophrenia and Disorders with Psychotic Features processed this record on February 27, 2015