Clinical trial NCT01143090: A Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Schizophrenia
Lurasidone
Latuda
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2010-06-14
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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).

Primary outcomes:
measure: Adverse Events
timeFrame: 6 months
Secondary outcomes:
measure: Efficacy
timeFrame: 6 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: K and S Professional Research Services
state: Arkansas
city: Escondido
country: United States
facility: Synergy Clinical Research of Escondido
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, Inc.
state: California
city: Oakland
country: United States
facility: Pacific Research Partners, LLC
state: California
city: Paramount
country: United States
facility: California Clinical Trials
state: California
city: Pasadena
country: United States
facility: Pasadena Research Institute
state: California
city: Pico Rivera
country: United States
facility: California Neuropsychopharmacology Clinical Research Institute (CNRI), LLC
state: California
city: San Diego
country: United States
facility: California Neuropsychopharmacology Clinical Research Institute (CNRI)
state: California
city: San Diego
country: United States
facility: University of California San Diego Medical Center
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Network, South Bay
state: California
city: Denver
country: United States
facility: Western Affiliated Research Institute
state: Colorado
city: Atlanta
country: United States
facility: Comprehensive NeuroScience, Inc.
state: Georgia
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials
state: Louisiana
city: St. Charles
country: United States
facility: St. Charles Psychiatric Associates - Midwest Research
state: Missouri
city: Cedarhurst
country: United States
facility: Neurobehavioral Research, Inc.
state: New York
city: Glen Oaks
country: United States
facility: The Zucker Hillside Hospital
state: New York
city: Durham
country: United States
facility: Duke University Dept. of Psychiatry
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: CRI Worldwide - Kirkbride Center
state: Pennsylvania
city: Austin
country: United States
facility: FutureSearch Clinical Trials, LP
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas
state: Texas
city: Dallas
country: United States
facility: Pillar Clinical Research, LLC
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Wharton
country: United States
facility: Wharton Research Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine
state: Utah
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: 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):330-9. doi: 10.1017/S109285291300093X. Epub 2013 Dec 16.
citation: Awad G, Ng-Mak D, Rajagopalan K, Hsu J, Pikalov A, Loebel A. Long-term health-related quality of life improvements among patients treated with lurasidone: results from the open-label extension of a switch trial in schizophrenia. BMC Psychiatry. 2016 Jun 1;16:176. doi: 10.1186/s12888-016-0879-5.