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A Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder (Switch Ext)

This study has been completed.
Information provided by (Responsible Party):
Sunovion Identifier:
First received: June 10, 2010
Last updated: May 19, 2015
Last verified: May 2015
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 purpose of this study is to characterize the long-term safety and tolerability of lurasidone in subjects with schizophrenia or schizoaffective disorder and to allow for continued treatment for subjects completing the core study (D1050289-NCT01143077).

Condition Intervention Phase
Schizoaffective Disorder
Drug: Lurasidone HCl
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 24-Week, Flexible-Dose, Open-label Extension Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder (Protocol No. D1050290)

Resource links provided by NLM:

Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: 6 months ]
    Proportions of subjects with AEs, SAEs, and discontinuations due to AEs.

Secondary Outcome Measures:
  • Efficacy [ Time Frame: 6 months ]
    Long-term efficacy of lurasidone in subjects with schizophrenia or schizoaffective disorder who have completed Study D1050289

Enrollment: 149
Study Start Date: August 2010
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open Label
Subjects will continue on treatment with the same dose of lurasidone flexible dosing - 40 mg to 12 mg once daily taken orallay at endpoint of the D1050289 ( NCT01143077) core study.
Drug: Lurasidone HCl
40 mg Lurasidone tablets, 40 - 120 mg per day for up to 6 months


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject has completed 6 weeks of treatment and all required assessments on the final study visit (Visit 8) of Study D1050289 (NCT01143077).

Exclusion Criteria:

  • Subject is considered by the investigator to be at imminent risk of suicide or harm to self, others, or damage to property.
  • Subject has a body mass index (BMI) greater than 40 or less than 18 kg/m2 (see Appendix 3 for BMI determination).
  Contacts and Locations
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Please refer to this study by its identifier: NCT01143090

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sunovion Identifier: NCT01143090     History of Changes
Other Study ID Numbers: D1050290
Study First Received: June 10, 2010
Results First Received: November 15, 2012
Last Updated: May 19, 2015

Keywords provided by Sunovion:

Additional relevant MeSH terms:
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Lurasidone Hydrochloride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents processed this record on May 25, 2017