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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00711269
First Posted: July 8, 2008
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sumitomo Dainippon Pharma Co., Ltd.
  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:


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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Sumitomo Dainippon Pharma Co., Ltd.
Investigators
Study Director: Drug Development Division Dainippon Sumitomo Pharma Co., Ltd.
  More Information

ClinicalTrials.gov Identifier: NCT00711269     History of Changes
Other Study ID Numbers: D1001002
JapicCTI-080585
First Submitted: June 11, 2008
First Posted: July 8, 2008
Last Update Posted: October 12, 2017
Last Verified: June 2012

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Lurasidone Hydrochloride
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Serotonin 5-HT2 Receptor Antagonists
Dopamine D2 Receptor Antagonists