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

Phase 3

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder
• Interventions: Drug: Lurasidone HCl

• Registration Number: NCT01143077
• Lead Sponsor: Sumitomo Pharma America, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-10
• Study First Submitted QC: 2010-06-11
• Study First Posted: 2010-06-14
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2012-05-15
• Results First Submitted QC: 2012-07-10
• Results First Posted: 2012-08-16
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-09
• Last Update Posted: 2013-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 244

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lurasidone Open-Label Arm A	Lurasidone HCl	-
Lurasidone Open-Label Arm B	Lurasidone HCl	-
Lurasidone Open-Label Arm C	Lurasidone HCl	-

Primary Outcome Measures

Name	Time	Method
Time to Relapse of Psychotic Symptoms During 6 Weeks	6 Weeks	Relapse is defined as any occurrence of: * Insufficient clinical response; * Exacerbation of underlying disease; * Discontinuation due to an adverse event

Secondary Outcome Measures

Name	Time	Method
Tolerability and Safety	6 Weeks	Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events

Trial Locations

Locations (27)

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

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