| Primary | Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | The Montgomery-Åsberg Depression Rating Scale is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms. | Combined MDD and Bipolar Depression Mixed Features Population | Posted | | Least Squares Mean | Standard Error | score on a scale | | Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Lumateperone 42mg | Lumateperone 42mg administered once daily in the evening Lumateperone: Lumateperone 42mg oral capsule | | OG001 | Placebo | Matching placebo administered once daily in the evening Placebos: Placebo oral capsule |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-18.1± 0.71
- OG001-12.4± 0.70
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Mixed Effects Model for Repeated Measure | | <0.0001 | | Least Squares Mean Difference | -5.7 | Standard Error of the Mean | 0.96 | 2-Sided | 95 | -7.60 | -3.84 | | | | | Superiority | | |
|
| Primary | Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | The Montgomery-Åsberg Depression Rating Scale is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms. | Bipolar Depression Mixed Features Population | Posted | | Least Squares Mean | Standard Error | score on a scale | | Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Lumateperone 42mg | Lumateperone 42mg administered once daily in the evening Lumateperone: Lumateperone 42mg oral capsule | | OG001 | Placebo | Matching placebo administered once daily in the evening Placebos: Placebo oral capsule |
| |
| Primary | Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | The Montgomery-Åsberg Depression Rating Scale is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms. | MDD Mixed Features Population | Posted | | Least Squares Mean | Standard Error | score on a scale | | Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Lumateperone 42mg | Lumateperone 42mg administered once daily in the evening Lumateperone: Lumateperone 42mg oral capsule | | OG001 | Placebo | Matching placebo administered once daily in the evening Placebos: Placebo oral capsule |
| |
| Primary | Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | The Montgomery-Åsberg Depression Rating Scale is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms. | | Posted | | Least Squares Mean | Standard Error | score on a scale | | Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Lumateperone 42mg | Lumateperone 42mg administered once daily in the evening Lumateperone: Lumateperone 42mg oral capsule | | OG001 | Placebo | Matching placebo administered once daily in the evening Placebos: Placebo oral capsule |
| |
| Secondary | Clinical From Baseline in Clinical Global Impression Scale - Severity (CGI-S) | The Clinical Global Impression Scale-Severity is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). | Combined MDD and Bipolar Depression Mixed Features Population | Posted | | Least Squares Mean | Standard Error | score on a scale | | Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Lumateperone 42mg | Lumateperone 42mg administered once daily in the evening Lumateperone: Lumateperone 42mg oral capsule | | OG001 | Placebo | Matching placebo administered once daily in the evening Placebos: Placebo oral capsule |
| |
| Secondary | Clinical From Baseline in Clinical Global Impression Scale - Severity (CGI-S) | The Clinical Global Impression Scale-Severity is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). | Bipolar Depression Mixed Features Population | Posted | | Least Squares Mean | Standard Error | score on a scale | | Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Lumateperone 42mg | Lumateperone 42mg administered once daily in the evening Lumateperone: Lumateperone 42mg oral capsule | | OG001 | Placebo | Matching placebo administered once daily in the evening Placebos: Placebo oral capsule |
| |
| Secondary | Clinical From Baseline in Clinical Global Impression Scale - Severity (CGI-S) | The Clinical Global Impression Scale-Severity is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). | MDD Mixed Features Population | Posted | | Least Squares Mean | Standard Error | score on a scale | | Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Lumateperone 42mg | Lumateperone 42mg administered once daily in the evening Lumateperone: Lumateperone 42mg oral capsule | | OG001 | Placebo | Matching placebo administered once daily in the evening Placebos: Placebo oral capsule |
| |
| Secondary | Clinical From Baseline in Clinical Global Impression Scale - Severity (CGI-S) | The Clinical Global Impression Scale-Severity is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). | | Posted | | Least Squares Mean | Standard Error | score on a scale | | Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Lumateperone 42mg | Lumateperone 42mg administered once daily in the evening Lumateperone: Lumateperone 42mg oral capsule | | OG001 | Placebo | Matching placebo administered once daily in the evening Placebos: Placebo oral capsule |
| |