A Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder

Schizophrenia Clinical Trial

— Switch Ext  

Official title:

A 24-Week, Flexible-Dose, Open-label Extension Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder (Protocol No. D1050290)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01143090
• Other study ID #: D1050290
• Status: Completed
• Phase: Phase 3
• First received: June 10, 2010
• Last updated: May 19, 2015
• Start date: August 2010

Study information

• Verified date: May 2015
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia. Switching between antipsychotic medications is common in the treatment of schizophrenia. The purpose of this study is to characterize the long-term safety and tolerability of lurasidone in subjects with schizophrenia or schizoaffective disorder and to allow for continued treatment for subjects completing the core study (D1050289-NCT01143077).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject has completed 6 weeks of treatment and all required assessments on the final study visit (Visit 8) of Study D1050289 (NCT01143077).

Exclusion Criteria:

• Subject is considered by the investigator to be at imminent risk of suicide or harm to self, others, or damage to property.

• Subject has a body mass index (BMI) greater than 40 or less than 18 kg/m2 (see Appendix 3 for BMI determination).

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• Lurasidone HCl
40 mg Lurasidone tablets, 40 - 120 mg per day for up to 6 months

Locations

Country	Name	City	State
United States	Comprehensive NeuroScience, Inc.	Atlanta	Georgia
United States	Medical College of Georgia	Augusta	Georgia
United States	FutureSearch Clinical Trials, LP	Austin	Texas
United States	Neurobehavioral Research, Inc.	Cedarhurst	New York
United States	University of Illinois at Chicago	Chicago	Illinois
United States	FutureSearch Trials of Dallas	Dallas	Texas
United States	Pillar Clinical Research, LLC	Dallas	Texas
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Western Affiliated Research Institute	Denver	Colorado
United States	Duke University Dept. of Psychiatry	Durham	North Carolina
United States	Synergy Clinical Research of Escondido	Escondido	California
United States	Collaborative Neuroscience Network, Inc.	Garden Grove	California
United States	The Zucker Hillside Hospital	Glen Oaks	New York
United States	Lake Charles Clinical Trials	Lake Charles	Louisiana
United States	K and S Professional Research Services	Little Rock	Arkansas
United States	Pacific Research Partners, LLC	Oakland	California
United States	California Clinical Trials	Paramount	California
United States	Pasadena Research Institute	Pasadena	California
United States	CRI Worldwide - Kirkbride Center	Philadelphia	Pennsylvania
United States	California Neuropsychopharmacology Clinical Research Institute (CNRI), LLC	Pico Rivera	California
United States	University of Utah School of Medicine	Salt Lake City	Utah
United States	California Neuropsychopharmacology Clinical Research Institute (CNRI)	San Diego	California
United States	University of California San Diego Medical Center	San Diego	California
United States	St. Charles Psychiatric Associates - Midwest Research	St. Charles	Missouri
United States	Collaborative Neuroscience Network, South Bay	Torrance	California
United States	Wharton Research Center	Wharton	Texas
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

References & Publications (1)

Citrome L, Weiden PJ, McEvoy JP, Correll CU, Cucchiaro J, Hsu J, Loebel A. Effectiveness of lurasidone in schizophrenia or schizoaffective patients switched from other antipsychotics: a 6-month, open-label, extension study. CNS Spectr. 2014 Aug;19(4):330- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Proportions of subjects with AEs, SAEs, and discontinuations due to AEs.	6 months	Yes
Secondary	Efficacy	Long-term efficacy of lurasidone in subjects with schizophrenia or schizoaffective disorder who have completed Study D1050289	6 months	No