A Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder (Switch Ext)
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| ClinicalTrials.gov Identifier: NCT01143090 |
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Recruitment Status :
Completed
First Posted : June 14, 2010
Results First Posted : December 17, 2012
Last Update Posted : June 12, 2015
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Sponsor:
Sunovion
Information provided by (Responsible Party):
Sunovion
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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 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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Schizophrenia Schizoaffective Disorder | Drug: Lurasidone HCl | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 149 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (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) |
| Study Start Date : | August 2010 |
| Actual Primary Completion Date : | November 2011 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Schizophrenia
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Lurasidone HCl
40 mg Lurasidone tablets, 40 - 120 mg per day for up to 6 months |
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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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).
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01143090
Locations
Show 27 study locations
Sponsors and Collaborators
Sunovion
Investigators
| Study Director: | Medical Director, MD | Sunovion |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sunovion |
| ClinicalTrials.gov Identifier: | NCT01143090 |
| Other Study ID Numbers: |
D1050290 |
| First Posted: | June 14, 2010 Key Record Dates |
| Results First Posted: | December 17, 2012 |
| Last Update Posted: | June 12, 2015 |
| Last Verified: | May 2015 |
Keywords provided by Sunovion:
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Schizophrenia Lurasidone Latuda |
Additional relevant MeSH terms:
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Schizophrenia Psychotic Disorders 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 |