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

This study has been completed.
Sponsor:
Information provided by:
Dainippon Sumitomo Pharma
ClinicalTrials.gov Identifier:
NCT00711269
First received: June 11, 2008
Last updated: June 11, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Schizophrenia
 Drug: SM-13496 (lurasidone HCl)
Drug: Placebo
Drug: Risperidone
 Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Randomized, Placebo-controlled, Double-blind, Parallel-group, Confirmatory Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia <Phase III Study>

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Dainippon Sumitomo Pharma:

Primary Outcome Measures:
  • Change from baseline in PANSS total score

Secondary Outcome Measures:
  • Efficacy: Change from baseline in the PANSS total score by subscales etc. Safety: Proportion of subjects with Adverse Events (AEs), Discontinuations due to AEs, and Serious Adverse Events (SAEs).

Estimated Enrollment: 440
Study Start Date: July 2008
Arms Assigned Interventions
Experimental: 1 Drug: SM-13496 (lurasidone HCl)
Lurasidone HCl: 40 mg/day
Experimental: 2 Drug: SM-13496 (lurasidone HCl)
Lurasidone HCl: 80 mg/day
Placebo Comparator: 3 Drug: Placebo
Active Comparator: 4 Drug: Risperidone

  Eligibility

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

Main Inclusion Criteria:

  • Patient meets DSM-IV criteria for schizophrenia.
  • Patient is 18 or older but younger than 75 years of age on the day of signing informed consent.
  • Patient understands the objectives, nature, and other aspects of the study and voluntarily agrees to participate in the study by providing written informed consent.

Main 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711269

Locations
Japan
Japan: 45 sites
Tokyo, etc., Japan
Korea, Republic of
Korea: 10 sites
Seoul, etc., Korea, Republic of
Taiwan
Taiwan: 7 sites
Taipei, etc., Taiwan
Sponsors and Collaborators
Dainippon Sumitomo Pharma
Investigators
Study Director: Drug Development Division Dainippon Sumitomo Pharma Co., Ltd.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00711269     History of Changes
Other Study ID Numbers: D1001002, JapicCTI-080585
Study First Received: June 11, 2008
Last Updated: June 11, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 16, 2013