Status:
COMPLETED
A Study Evaluating Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 medication...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT01143077
Start Date
June 1 2010
End Date
May 1 2011
Last Update
April 17 2013
Active Locations (27)
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1
K and S Professional Research Services
Little Rock, Arkansas, United States, 72201
2
Synergy Clinical Research of Escondido
Escondido, California, United States, 92025
3
Collaborative Neuroscience Network, Inc.
Garden Grove, California, United States, 92845
4
Pacific Research Partners, LLC
Oakland, California, United States, 94612