Bipolar Depression
Conditions
Keywords
Bipolar, Depression, Lurasidone, Latuda
Brief summary
This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression
Interventions
DRUGlurasidone
Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
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 75 Years
Healthy volunteers
No
Inclusion criteria
* Subject is judged by the investigator to be suitable for participation in a 24-week clinical trial involving open-label lurasidone treatment * Subject has completed the 6-week treatment period and all required assessments on the final study visit (Day 42, Visit 8) of either Study D1050235, NCT#00868452 or Study D1050236, NCT#008668699.
Exclusion criteria
* Imminent risk of suicide, injury to self or to others, or damage to property * Subject has evidence of severe movement disorders. * Subject tests positive for drugs of abuse (at Visit 8 in Study D1050235, NCT#00868452 or D1050236, NCT#008688699).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment | 24 weeks | Rate of treatment-emergent adverse events in subjects who have completed (ie, reached 6-week endpoint) of Study D1050235 (NCT00868452), Study D1050236 (NCT00868699) or Study D1050292 (NCT01284517) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | 24 weeks | The MADRS is a clinician-rated assessment of the subject's level of depression. Ten items are rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of ten items: reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity. |
| Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Clinical Global Impressions Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression) | 24 weeks | This CGI-BP-S is a clinician-rated assessment of the subjects current severity of depression and ranges from 1=Normal, not ill to 7=Very severly ill. Higher scores are associated with greater severity. |
Countries
Canada, Colombia, Czechia, France, India, Japan, Lithuania, Peru, Poland, Romania, Russia, Slovakia, South Africa, Ukraine, United States
Participant flow
Pre-assignment details
817 represents the total number of subjects who provided informed consent and enrolled, which is different from the total number of subjects who were treated with study drug, which was 813.
Participants by arm
| Arm | Count |
|---|---|
| Lurasidone lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks | 813 |
| Total | 813 |
Baseline characteristics
| Characteristic | Lurasidone |
|---|---|
| Age, Categorical <=18 years | 6 Participants |
| Age, Categorical >=65 years | 17 Participants |
| Age, Categorical Between 18 and 65 years | 790 Participants |
| Age, Continuous | 42.7 years STANDARD_DEVIATION 12.03 |
| Region of Enrollment Canada | 14 participants |
| Region of Enrollment Colombia | 15 participants |
| Region of Enrollment Czech Republic | 108 participants |
| Region of Enrollment France | 23 participants |
| Region of Enrollment Germany | 3 participants |
| Region of Enrollment India | 128 participants |
| Region of Enrollment Japan | 6 participants |
| Region of Enrollment Lithuania | 16 participants |
| Region of Enrollment Peru | 12 participants |
| Region of Enrollment Poland | 12 participants |
| Region of Enrollment Romania | 9 participants |
| Region of Enrollment Russian Federation | 31 participants |
| Region of Enrollment Slovakia | 19 participants |
| Region of Enrollment South Africa | 56 participants |
| Region of Enrollment Ukraine | 78 participants |
| Region of Enrollment United States | 283 participants |
| Sex: Female, Male Female | 427 Participants |
| Sex: Female, Male Male | 386 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 246 / 813 |
| serious Total, serious adverse events | 24 / 813 |
Outcome results
Primary
Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment
Rate of treatment-emergent adverse events in subjects who have completed (ie, reached 6-week endpoint) of Study D1050235 (NCT00868452), Study D1050236 (NCT00868699) or Study D1050292 (NCT01284517)
Time frame: 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lurasidone | Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment | 529 participants |
Secondary
Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Clinical Global Impressions Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)
This CGI-BP-S is a clinician-rated assessment of the subjects current severity of depression and ranges from 1=Normal, not ill to 7=Very severly ill. Higher scores are associated with greater severity.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lurasidone | Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Clinical Global Impressions Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression) | -0.58 units on a scale | Standard Deviation 1.325 |
Secondary
Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
The MADRS is a clinician-rated assessment of the subject's level of depression. Ten items are rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of ten items: reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lurasidone | Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | -4.4 units on a scale | Standard Deviation 10.6 |