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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:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01143077
First received: June 10, 2010
Last updated: April 9, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
 Drug: Lurasidone HCl
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Time to Relapse of Psychotic Symptoms During 6 Weeks [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

    Relapse is defined as any occurrence of:

    • Insufficient clinical response
    • Exacerbation of underlying disease
    • Discontinuation due to an adverse event


Secondary Outcome Measures:
  • Tolerability and Safety [ Time Frame: 6 Weeks ] [ Designated as safety issue: Yes ]
    Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events


Enrollment: 244
Study Start Date: June 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lurasidone Open-Label Arm A 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 B 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 C Drug: Lurasidone HCl
Lurasidone tablets, 40 mg/daily, 80 mg/daily, 120 mg/daily for 6 weeks
Other Name: Latuda

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01143077

  Show 27 Study Locations
Sponsors and Collaborators
Sunovion
Investigators
Study Director: Lurasidone Medical Director, MD Sunovion
  More Information

Publications:

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01143077     History of Changes
Other Study ID Numbers: D1050289
Study First Received: June 10, 2010
Results First Received: May 15, 2012
Last Updated: April 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunovion:
Lurasidone
Schizophrenia
Latuda

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 23, 2013