Schizophrenia
Conditions
Keywords
Schizophrenia, Latuda, Lurasidone
Brief summary
A 1-year outpatient study to test the safety and tolerability of a new medication in the treatment of schizophrenia
Detailed description
Study will evaluate long-term safety and tolerability of a new compound in the treatment of patients with schizophrenia as assessed by adverse events (AEs), measures of extra pyramidal symptoms (EPS; Abnormal Involuntary Movement Scale \[AIMS\], Barnes Akathisia Scale \[BAS\], and Simpson-Angus Rating Scale \[SAS\]), vital sign measurements, electrocardiograms (ECGs), clinical laboratory evaluations.
Interventions
DRUGLurasidone 80mg tablet
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Patients must have participated in study D1050196 (A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia) and either: * Successfully completed * OR * Patients must have been discontinued after a minimum of 2 weeks of treatment due to lack of efficacy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study | 1 year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lurasidone 80 mg Lurasidone 80mg oral tablet. The number of subjects that represent the baseline must have taken 1 dose of study medication and had post-baseline assessment. 2 subjects were randomized and did not take study medication and thus 59 subjects is listed in the baseline group. | 59 |
| Total | 59 |
Baseline characteristics
| Characteristic | Lurasidone 80 mg |
|---|---|
| Age, Continuous | 41.3 years STANDARD_DEVIATION 11.05 |
| Region of Enrollment United States | 59 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 18 / 59 |
| serious Total, serious adverse events | 12 / 59 |
Outcome results
Primary
Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study
Time frame: 1 year
Population: Number of subjects that entered into the extension trial.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lurasidone 80 mg | Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study | 59 participants |