Clinical trial NCT01143077: A Study Evaluating Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Lurasidone
Schizophrenia
Latuda
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2010-06-14
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Time to Relapse of Psychotic Symptoms During 6 Weeks
timeFrame: 6 Weeks
Secondary outcomes:
measure: Tolerability and Safety
timeFrame: 6 Weeks
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, LLC
state: Louisiana
city: St. Charles
country: United States
facility: Saint Charles Psychiatric Associates/Midwest Research Group
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 Health Sciences
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: Houston
country: United States
facility: Wharton Research Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospitals and Clinics
state: Utah
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Lurasidone Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: 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 Psychiatry. 2013 Feb;74(2):170-9. doi: 10.4088/JCP.12m07992.
citation: Awad G, Hassan M, Loebel A, Hsu J, Pikalov A, Rajagopalan K. Health-related quality of life among patients treated with lurasidone: results from a switch trial in patients with schizophrenia. BMC Psychiatry. 2014 Feb 23;14:53. doi: 10.1186/1471-244X-14-53.