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

Completed · Phase 3

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

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.

Key facts

Study ID

NCT01143077

Run by

Sumitomo Pharma America, Inc.

People needed

244

Starts

2010-06-01

Expected to finish

2011-05-01

Last updated by the study team

2013-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

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

Full record on ClinicalTrials.gov

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