Schizophrenia
Conditions
Keywords
Schizophrenia, Latuda, Lurasidone
Brief summary
The purpose of this study is to evaluate the long-term safety of SM-13496 in patients with schizophrenia.
Interventions
DRUGLurasidone 20 mg
Lurasidone 20mg oral tablet taken once daily for 6-months
DRUGLurasidone 40 mg
Lurasidone 40mg oral tablets taken once daily
DRUGLurasidone 80mg
Lurasidone 80mg oral tablet taken once daily
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Successful completion of participation in protocol #D1050049
Exclusion criteria
* Substance abuse * Prolactin level of ≥200ng/mL at baseline * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 6-months | The primary objective of this 6-month open-label study was to evaluate the safety of 3 doses of lurasidone. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lurasidone 20 mg Lurasdione 20 mg oral tablets | 32 |
| Lurasidone 40 mg Lurasidone 40 mg oral tablets | 33 |
| Lurasidone 80mg Lurasidone 80mg oral tablets | 33 |
| Total | 98 |
Baseline characteristics
| Characteristic | Lurasidone 20 mg | Lurasidone 40 mg | Lurasidone 80mg | Total |
|---|---|---|---|---|
| Age, Continuous | 40.8 years STANDARD_DEVIATION 7.8 | 42.2 years STANDARD_DEVIATION 12.4 | 40.8 years STANDARD_DEVIATION 10.7 | 41.3 years STANDARD_DEVIATION 10.4 |
| Region of Enrollment United States | 32 participants | 33 participants | 33 participants | 98 participants |
| Sex: Female, Male Female | 11 Participants | 12 Participants | 5 Participants | 28 Participants |
| Sex: Female, Male Male | 21 Participants | 21 Participants | 28 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 19 / 32 | 22 / 33 | 18 / 33 |
| serious Total, serious adverse events | 3 / 32 | 6 / 33 | 3 / 33 |
Outcome results
Primary
Number of Participants With Adverse Events
The primary objective of this 6-month open-label study was to evaluate the safety of 3 doses of lurasidone.
Time frame: 6-months
Population: No formal hypothesis testing was performed. However,descriptive statistics were provided and data summarized. Safety analyses were conducted on the safety population, that included all subjects who had received at least 1 dose of open-label study medication.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Lurasidone 20 mg | Number of Participants With Adverse Events | 19 participants | 7.8 |
| Lurasidone 40 mg | Number of Participants With Adverse Events | 22 participants | 12.4 |
| Lurasidone 80mg | Number of Participants With Adverse Events | 18 participants | 10.7 |