Phase 3
N=149
A Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder
Schizophrenia · Schizoaffective Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01143090 ↗Enrolled (actual)
149
Serious AEs
5.4%
Results posted
Dec 2012
Primary outcome: Primary: Adverse Events — 98; 10; 16 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lurasidone HCl (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sumitomo Pharma America, Inc.
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
98; 10; 16 | — |
| SECONDARY Efficacy |
— | — |
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).
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT01143090). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.