Major Depressive Disorder
Conditions
Keywords
Depression, Lurasidone, Latuda
Brief summary
Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features over time.
Interventions
DRUGLurasidone
Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed
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 provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator. Subject has completed 6 weeks of treatment in Study D1050304 (NCT#01421134) or Study D1050305 (NCT#01423240). Subject is judged by the Investigator to be suitable for participation in a 12-week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.
Exclusion criteria
Subject answers yes to Suicidal Ideation Item 4 or 5 on the C-SSRS (at time of evaluation) at baseline (Day 43 in Study D1050304 or D1050305). Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or property.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) | 12 Weeks | Percentage of subjects with treatment emergent adverse events (TEAEs) |
| Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs) | 12 Weeks | Percentage of subjects with Treatment Emergent Serious Adverse Events (TESAEs) |
| Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs) | 12 Weeks | Percentage of subjects who discontinued due to Treatment Emergent Adverse Events (TEAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score | Baseline to week 12 | The Hamilton Rating Scale for Anxiety (HAM-A) is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety. |
| Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores | Baseline to12 Weeks | Mean change from baseline to week 12 (LOCF) in Montgomery-Asberg Depression Rating Scale (MADRS) total scores The MADRS is a clinician-rated assessment of the subject's level of depression and consists of 10 items. Each item is rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the ten items and ranges from 0 to 60. Higher scores are associated with greater severity. |
| Change From Baseline to Week 12 (LOCF) in the SDS Total Score | Baseline to week 12 | The Sheehan Disability Scale (SDS) is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient's life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1-3 (mild), 4-6 (moderate), 7-9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired). |
| Change From Baseline to Week 12 (LOCF) in CGI-S Score | baseline to week 12 | The Clinical Global Impression - Severity of illness (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. |
| Change From Baseline to Week 12 (LOCF) in the YMRS Total Score | Baseline to week 12 | The Young Mania Rating Scale (YMRS) is an 11-item instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 items and ranges from 0 to 60. Higher scores are associated with greater severity of mania. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lurasidone 20, 40, 60 mg Lurasidone 20, 40, or 60 mg/day flexibly dosed
Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed | 48 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Lurasidone 20, 40, 60 mg |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants |
| Age, Continuous | 42.5 Years STANDARD_DEVIATION 13.42 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 21 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 | 2 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment United States | 48 participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 16 / 48 |
| serious Total, serious adverse events | 0 / 48 |
Outcome results
Primary
Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs)
Percentage of subjects who discontinued due to Treatment Emergent Adverse Events (TEAEs)
Time frame: 12 Weeks
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lurasidone 20, 40, 60 mg | Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs) | 4.2 percentage of subjects |
Primary
Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs)
Percentage of subjects with treatment emergent adverse events (TEAEs)
Time frame: 12 Weeks
Population: Safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lurasidone 20, 40, 60 mg | Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) | 66.7 percentage of subjects |
Primary
Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs)
Percentage of subjects with Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: 12 Weeks
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lurasidone 20, 40, 60 mg | Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs) | 0 percentage of subjects |
Secondary
Change From Baseline to Week 12 (LOCF) in CGI-S Score
The Clinical Global Impression - Severity of illness (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: baseline to week 12
Population: Safety population - 1 subject did not have the CGI-S assessment at week 12 (LOCF)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lurasidone 20, 40, 60 mg | Change From Baseline to Week 12 (LOCF) in CGI-S Score | -0.47 units on a scale | Standard Deviation 1.442 |
Secondary
Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score
The Hamilton Rating Scale for Anxiety (HAM-A) is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety.
Time frame: Baseline to week 12
Population: Safety Population - 4 subjects did not have the HAM-A assessment at week 12 (LOCF)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lurasidone 20, 40, 60 mg | Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score | -1.5 units on a scale | Standard Deviation 6.48 |
Secondary
Change From Baseline to Week 12 (LOCF) in the SDS Total Score
The Sheehan Disability Scale (SDS) is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient's life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1-3 (mild), 4-6 (moderate), 7-9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired).
Time frame: Baseline to week 12
Population: Safety Population - 12 subjects did not have the SDS total score at week 12 (LOCF)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lurasidone 20, 40, 60 mg | Change From Baseline to Week 12 (LOCF) in the SDS Total Score | -3.6 units on a scale | Standard Deviation 9.95 |
Secondary
Change From Baseline to Week 12 (LOCF) in the YMRS Total Score
The Young Mania Rating Scale (YMRS) is an 11-item instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 items and ranges from 0 to 60. Higher scores are associated with greater severity of mania.
Time frame: Baseline to week 12
Population: Safety population - 2 subject did not have YMRS assessment at week 12 (LOCF)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lurasidone 20, 40, 60 mg | Change From Baseline to Week 12 (LOCF) in the YMRS Total Score | -1.5 units on a scale | Standard Deviation 6.17 |
Secondary
Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores
Mean change from baseline to week 12 (LOCF) in Montgomery-Asberg Depression Rating Scale (MADRS) total scores The MADRS is a clinician-rated assessment of the subject's level of depression and consists of 10 items. Each item is rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the ten items and ranges from 0 to 60. Higher scores are associated with greater severity.
Time frame: Baseline to12 Weeks
Population: Safety population - only 47 subjects had the MADRS assessment at Week 12 (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lurasidone 20, 40, 60 mg | Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores | -5.9 units on a scale | Standard Deviation 12.94 |