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

This study is currently recruiting participants.

Verified by Dainippon Sumitomo Pharma, February 2009

First Received: June 11, 2008 Last Updated: February 6, 2009 History of Changes

Sponsored by:	Dainippon Sumitomo Pharma
Information provided by:	Dainippon Sumitomo Pharma
ClinicalTrials.gov Identifier:	NCT00711269

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 III

Study Type:	Interventional
Study Design:	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

Drug Information available for: Risperidone Lurasidone SM-13496

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
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: SM-13496 (lurasidone HCl) Lurasidone HCl: 40 mg/day
2: Experimental	Drug: SM-13496 (lurasidone HCl) Lurasidone HCl: 80 mg/day
3: Placebo Comparator	Drug: Placebo
4: Active Comparator	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

Contacts

Contact: Dainippon Sumitomo Pharma Co., Ltd.

pr@ds-pharma.co.jp

Locations

Japan
Japan: 45 sites	Recruiting
Tokyo, etc., Japan
Korea, Republic of
Korea: 10 sites	Recruiting
Seoul, etc., Korea, Republic of
Taiwan
Taiwan: 7 sites	Recruiting
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

Study ID Numbers:	D1001002, JapicCTI-080585
Study First Received:	June 11, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00711269 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare; South Korea: Korea Food and Drug Administration (KFDA); Taiwan: Department of Health

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Risperidone
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Serotonin

Schizophrenia
Dopamine
Mental Disorders
Psychotic Disorders
Dopamine Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Risperidone
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents

Pharmacologic Actions
Schizophrenia
Serotonin Antagonists
Serotonin Agents
Mental Disorders
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 11, 2009