Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
Schizophrenia, Lurasidone, Latuda
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).
Interventions
DRUGLurasidone HCl
40 mg Lurasidone tablets, 40 - 120 mg per day for up to 6 months
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 6 months | Proportions of subjects with AEs, SAEs, and discontinuations due to AEs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 6 months | Long-term efficacy of lurasidone in subjects with schizophrenia or schizoaffective disorder who have completed Study D1050289 |
Countries
United States
Participant flow
Recruitment details
FPI August 10, 2010-LPV November 28, 2011, locations were private health clinics, university hospitals, private research facilities.
Participants by arm
| Arm | Count |
|---|---|
| Open Label Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study. One enrolled subject did not receive any study medication and was excluded from this summary. | 148 |
| Total | 148 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative | 1 |
| Overall Study | Adverse Event | 17 |
| Overall Study | Failure to meet eligibility criteria | 1 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Lost to Follow-up | 9 |
| Overall Study | Non-compliance with study drug | 1 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Withdrawal by Subject | 18 |
Baseline characteristics
| Characteristic | Open Label |
|---|---|
| Age, Categorical <=18 years | 2 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 146 Participants |
| Age, Continuous | 42.8 years STANDARD_DEVIATION 11.1 |
| Region of Enrollment United States | 148 participants |
| Sex: Female, Male Female | 55 Participants |
| Sex: Female, Male Male | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 47 / 148 |
| serious Total, serious adverse events | 8 / 148 |
Outcome results
Primary
Adverse Events
Proportions of subjects with AEs, SAEs, and discontinuations due to AEs.
Time frame: 6 months
Population: Safety population - One enrolled subject did not receive any study medication and was excluded from this summary.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lurasidone Overall | Adverse Events | Any Treatment Emergent Adverse Event | 98 participants |
| Lurasidone Overall | Adverse Events | Any Severe Treatment Emergent Adverse Event | 10 participants |
| Lurasidone Overall | Adverse Events | Treatment Emergent AE Leading to Discontinuation | 16 participants |
Secondary
Efficacy
Long-term efficacy of lurasidone in subjects with schizophrenia or schizoaffective disorder who have completed Study D1050289
Time frame: 6 months