A Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder
- Registration Number
- NCT01143090
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 149
- Subject has completed 6 weeks of treatment and all required assessments on the final study visit (Visit 8) of Study D1050289 (NCT01143077).
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Open Label Lurasidone HCl 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.
- Primary Outcome Measures
Name Time Method Adverse Events 6 months Proportions of subjects with AEs, SAEs, and discontinuations due to AEs.
- Secondary Outcome Measures
Name Time Method Efficacy 6 months Long-term efficacy of lurasidone in subjects with schizophrenia or schizoaffective disorder who have completed Study D1050289
Trial Locations
- Locations (27)
K and S Professional Research Services
🇺🇸Little Rock, Arkansas, United States
Synergy Clinical Research of Escondido
🇺🇸Escondido, California, United States
Collaborative Neuroscience Network, Inc.
🇺🇸Garden Grove, California, United States
Pacific Research Partners, LLC
🇺🇸Oakland, California, United States
California Clinical Trials
🇺🇸Paramount, California, United States
Pasadena Research Institute
🇺🇸Pasadena, California, United States
California Neuropsychopharmacology Clinical Research Institute (CNRI), LLC
🇺🇸Pico Rivera, California, United States
California Neuropsychopharmacology Clinical Research Institute (CNRI)
🇺🇸San Diego, California, United States
University of California San Diego Medical Center
🇺🇸San Diego, California, United States
Collaborative Neuroscience Network, South Bay
🇺🇸Torrance, California, United States
Scroll for more (17 remaining)K and S Professional Research Services🇺🇸Little Rock, Arkansas, United States