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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01143077
First Posted: June 14, 2010
Last Update Posted: April 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sunovion
June 10, 2010
June 14, 2010
May 15, 2012
August 16, 2012
April 17, 2013
June 2010
May 2011   (Final data collection date for primary outcome measure)
Time to Relapse of Psychotic Symptoms During 6 Weeks [ Time Frame: 6 Weeks ]

Relapse is defined as any occurrence of:

  • Insufficient clinical response
  • Exacerbation of underlying disease
  • Discontinuation due to an adverse event
Not Provided
Complete list of historical versions of study NCT01143077 on ClinicalTrials.gov Archive Site
Tolerability and Safety [ Time Frame: 6 Weeks ]
Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events
Not Provided
Not Provided
Not Provided
 
A Study Evaluating Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
Drug: Lurasidone HCl
Lurasidone tablets, 40 mg/daily, 80 mg/daily, 120 mg/daily for 6 weeks
Other Name: Latuda
  • Experimental: Lurasidone Open-Label Arm A
    Intervention: Drug: Lurasidone HCl
  • Experimental: Lurasidone Open-Label Arm B
    Intervention: Drug: Lurasidone HCl
  • Experimental: Lurasidone Open-Label Arm C
    Intervention: Drug: Lurasidone HCl

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
244
May 2011
May 2011   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01143077
D1050289
Yes
Not Provided
Not Provided
Sunovion
Sunovion
Not Provided
Study Director: Lurasidone Medical Director, MD Sunovion
Sunovion
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP