A Study Evaluating Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents

Schizophrenia Clinical Trial

— SWITCHCore  

Official title:

A Randomized, 6-week, Open-Label, Study Evaluating The Safety, Tolerability, and Efficacy of Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01143077
• Other study ID #: D1050289
• Status: Completed
• Phase: Phase 3
• First received: June 10, 2010
• Last updated: April 9, 2013
• Start date: June 2010
• Est. completion date: May 2011

Study information

• Verified date: April 2013
• 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 current study is designed to evaluate the effectiveness, safety, and tolerability of switching clinically stable, but symptomatic outpatients with schizophrenia or schizoaffective disorder from their preswitch antipsychotic medication to lurasidone, over a period of 6 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject = 18 years of age.

• Subject meets DSM-IV criteria for a primary diagnosis of schizophrenia or schizoaffective disorder.

• Subject must be judged by the investigator to be an appropriate candidate for switching current antipsychotic medication due to insufficient efficacy and/or safety or tolerability concerns.

Exclusion Criteria:

• Presence of an Axis I or Axis II disorder other than schizophrenia or schizoaffective disorder that is the primary focus of treatment prior to screening.

• Subject has experienced persistent lack of improvement in psychotic symptoms despite adequate trials (at least 6 weeks at standard doses), of two or more antipsychotic agents in the 12 months prior to screening.

• Subject is considered by the investigator to be at imminent risk of suicide or harm to self, others, or property. Subject has suicidal ideation at baseline or has attempted suicide within 90 days prior to randomization (even without hospitalization).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• Lurasidone HCl
Lurasidone tablets, 40 mg/daily, 80 mg/daily, 120 mg/daily for 6 weeks

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	Wharton Research Center	Houston	Texas
United States	Lake Charles Clinical Trials, LLC	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 Hospitals and Clinics	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	Saint Charles Psychiatric Associates/Midwest Research Group	St. Charles	Missouri
United States	Collaborative Neuroscience Network, South Bay	Torrance	California
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

References & Publications (1)

McEvoy JP, Citrome L, Hernandez D, Cucchiaro J, Hsu J, Pikalov A, Loebel A. Effectiveness of lurasidone in patients with schizophrenia or schizoaffective disorder switched from other antipsychotics: a randomized, 6-week, open-label study. J Clin Psychiatr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Relapse of Psychotic Symptoms During 6 Weeks	Relapse is defined as any occurrence of: Insufficient clinical response; Exacerbation of underlying disease; Discontinuation due to an adverse event	6 Weeks	No
Secondary	Tolerability and Safety	Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events	6 Weeks	Yes