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

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 3

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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone Lurasidone Lurasidone hydrochloride

U.S. FDA Resources

Further study details as provided by Sunovion:

Primary Outcome Measures:

Number of Participants With Adverse Events. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment:	629
Study Start Date:	March 2008
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

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

Show 73 Study Locations

Sponsors and Collaborators

Sunovion

Investigators

Study Director:

Medical Director, MD

Sunovion

More Information

No publications provided by Sunovion

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Citrome L, Cucchiaro J, Sarma K, Phillips D, Silva R, Tsuchiya S, Loebel A. Long-term safety and tolerability of lurasidone in schizophrenia: a 12-month, double-blind, active-controlled study. Int Clin Psychopharmacol. 2012 May;27(3):165-76.

Responsible Party:	Sunovion
ClinicalTrials.gov Identifier:	NCT00641745 History of Changes
Other Study ID Numbers:	D1050237
Study First Received:	March 18, 2008
Results First Received:	September 1, 2011
Last Updated:	September 1, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sunovion:

Lurasidone
Schizophrenia
Latuda

Additional relevant MeSH terms:

Psychotic Disorders
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