Lurasidone HCl - A Long Term Safety Phase 3 Study of Patients With Clinically Stable Schizophrenia - Full Text View

Sponsored by:	Dainippon Sumitomo Pharma America
Information provided by:	Dainippon Sumitomo Pharma America
ClinicalTrials.gov Identifier:	NCT00641745

Purpose

Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is safe and tolerable long term among clinically stable patients. The study will also assess the long term effectiveness of lurasidone as compared to an active comparator.

Condition	Intervention	Phase
Schizophrenia Schizoaffective Disorder	Drug: Lurasidone HCl Drug: Risperidone	Phase III

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone SM-13496 Lurasidone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment
Official Title:	Long-Term Safety, Tolerability, and Effectiveness of Lurasidone in Subjects With Schizophrenia or Schizoaffective Disorder: A Randomized, Active Comparator-Controlled Trial

Further study details as provided by Dainippon Sumitomo Pharma America:

Primary Outcome Measures:

Long Term Safety study: Safety will be assessed by the proportion of subjects with Adverse Events, Discontinuations due to AEs, and Serious Adverse Events. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Long Term Safety study: To evaluate safety of lurasidone treatment for up to 18 months based on metabolic parameters, ECG parameters, bone mineral density and ophthalmologic assessment, and effectiveness outcomes (PANSS, CGI-S, and MADRS). [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	600
Study Start Date:	March 2008
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Lurasidone	Drug: Lurasidone HCl 40 - 120mg per day
2: Active Comparator Risperidone	Drug: Risperidone Risperidone

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Main Inclusion Criteria:

To be eligible to enter the study, each patient must comply with the following inclusion criteria:

Subject is 18 to 75 years on the day of signing the consent form (age parameters may be restricted further per local requirements without protocol amendment).
Subject meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a primary diagnosis of schizophrenia (including disorganized (295.10), paranoid (295.30), undifferentiated (295.90), catatonic (295.20), or residual (295.60) or schizoaffective disorder (295.70) subtypes.
Subject is not pregnant or nursing, and is not planning pregnancy within the projected duration of the study.
Subject will comply with the study procedures and outpatient visit requirements in the opinion of the investigator.
Subject voluntarily agrees to participate in the study by giving written informed consent.

Main Exclusion Criteria:

To be excluded from entering this study if they fulfil any of the criteria below:

Subject has a chronic organic disease of the central nervous system (other than schizophrenia).
Subject has current clinically significant or history of, alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
In the opinion of the investigator, the subject has any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study.
Subject has participated in a study with an investigational compound or device within 30 days of signing informed consent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641745

Contacts

Contact: Kaushik Sarma, M.D.

201-228-8040

ksarma@dsp-a.com

Show 68 Study Locations

Sponsors and Collaborators

Dainippon Sumitomo Pharma America

More Information

Responsible Party:	Dainippon Sumitomo Pharma America, Inc. ( Kaushik Sarma, M.D. / Associate Manager, Clinical Development )
Study ID Numbers:	D1050237
Study First Received:	March 18, 2008
Last Updated:	October 31, 2008
ClinicalTrials.gov Identifier:	NCT00641745
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Schizophrenia
Dopamine
Mental Disorders
Risperidone

Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

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

Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009