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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01143090
First received: June 10, 2010
Last updated: January 3, 2013
Last verified: January 2013
  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 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
Schizophrenia
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 ] [ Designated as safety issue: Yes ]
    Proportions of subjects with AEs, SAEs, and discontinuations due to AEs.


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01143090

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

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01143090     History of Changes
Other Study ID Numbers: D1050290
Study First Received: June 10, 2010
Results First Received: November 15, 2012
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunovion:
Schizophrenia
Lurasidone
Latuda

Additional relevant MeSH terms:
Disease
Psychotic Disorders
Schizophrenia
Mental Disorders
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 21, 2014