Bipolar Disorder, Schizophrenia
Conditions
Keywords
Schizophrenia, bipolar disorder, Lurasidone, Latuda
Brief summary
This is an open-label continuation study designed to monitor the safety, tolerability and effectiveness of lurasidone in subjects who have completed participation in a lurasidone extension study (NCT00868959 and NCT01566162) and who may benefit from continued treatment with lurasidone.
Interventions
DRUGLurasidone
Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* The subject or legal guardian provides written informed consent. For eligible subjects under age 18, verbal assent is also required. * The subject has completed the extension phase of a prior lurasidone clinical study. Eligible subjects may enroll into this continuation study directly (or within 10 days) after completing the extension phase of a prior lurasidone clinical study. Subjects that have completed an extension study prior to the initiation of this protocol at the study site, may participate in this study up to 3 months after completion of the extension phase of the prior lurasidone study. * The subject is judged by the Investigator to be suitable for participation in a clinical study involving open-label lurasidone treatment and is able to comply with the protocol. * The subject, in the Investigator's judgment, may benefit from continued treatment with lurasidone
Exclusion criteria
* The subject is considered by the Investigator, to be at imminent risk for homicidal or suicidal behavior. * The subject resides in a country where lurasidone has been approved for any indication. * The subject is currently enrolled in any other investigational study. * The subject answers yes to Suicidal Ideation Items 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs | 18 months | Primary Safety assessments included spontaneous adverse event (AE) and serious adverse events (SAEs) monitoring. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Month 18 (LOCF) in the Clinical Global Impression Severity Score (CGI-S | 18 months | The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity. |
Countries
Canada, Colombia, Czechia, France, India, Lithuania, Romania, Russia, Serbia, Slovakia, South Africa, Ukraine
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lurasidone Lurasidone flexibly dosed
Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food | 162 |
| Total | 162 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 10 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Terminated by Sponsor | 95 |
| Overall Study | Withdrawal by Subject | 14 |
Baseline characteristics
| Characteristic | Lurasidone |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 159 Participants |
| Age, Continuous | 41.3 years STANDARD_DEVIATION 12.08 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 32 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 20 Participants |
| Race (NIH/OMB) White | 105 Participants |
| Region of Enrollment Canada | 3 participants |
| Region of Enrollment Colombia | 6 participants |
| Region of Enrollment Czech Republic | 25 participants |
| Region of Enrollment France | 6 participants |
| Region of Enrollment India | 32 participants |
| Region of Enrollment Lithuania | 8 participants |
| Region of Enrollment Romania | 2 participants |
| Region of Enrollment Russian Federation | 20 participants |
| Region of Enrollment Serbia | 6 participants |
| Region of Enrollment Slovakia | 17 participants |
| Region of Enrollment South Africa | 26 participants |
| Region of Enrollment Ukraine | 11 participants |
| Sex: Female, Male Female | 77 Participants |
| Sex: Female, Male Male | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 40 / 162 |
| serious Total, serious adverse events | 7 / 162 |
Outcome results
Primary
Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs
Primary Safety assessments included spontaneous adverse event (AE) and serious adverse events (SAEs) monitoring.
Time frame: 18 months
Population: Safety Population - subjects who took at least one dose of study medication
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lurasidone | Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs | Subject with at least on treatment emergent AE | 63 participants |
| Lurasidone | Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs | Subject with at least one treatment emergent SAE | 7 participants |
| Lurasidone | Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs | Subjects discontinued due to TEAE | 10 participants |
Secondary
Change From Baseline to Month 18 (LOCF) in the Clinical Global Impression Severity Score (CGI-S
The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.
Time frame: 18 months
Population: Only 153 subjects who had baseline and at least one post-baseline assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lurasidone | Change From Baseline to Month 18 (LOCF) in the Clinical Global Impression Severity Score (CGI-S | -0.18 units on a scale | Standard Deviation 0.877 |