Major Depressive Disorder
Conditions
Keywords
Adjunctive MDD Therapy
Brief summary
This is a multicenter, open-label, fixed dose, 26 week study of patients with MDD. Eligible patients from the lead-in studies will enter the Open-label Safety Study at the Screening/Baseline Visit (Visit 1/Day 1), at which point patient eligibility will be assessed and informed consent obtained.
Detailed description
At the Screening/Baseline Visit (Visit 1/Day 1), which is the same visit as Visit 8/Day 43 of the lead-in study, eligible patients will receive open-label lumateperone 42 mg once daily for approximately 26 weeks. Patients will continue their background ADT from the lead-in study. Patients will be seen for weekly visits through Visit 5/Week 4. Thereafter, visits will occur every two weeks. A Safety Follow-up visit will occur on Visit 17/Day 197, approximately 2 weeks after the last dose of open-label lumateperone 42 mg.
Interventions
DRUGLumateperone
Lumateperone 42 mg capsules administered orally, once daily
Sponsors
Intra-Cellular Therapies, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. In the opinion of the Investigator, patients must have safely completed the lead-in study. 2. Patient is taking their ADT as prescribed from the lead-in study.
Exclusion criteria
1. In the opinion of the Investigator, the patient is unable to comply with study procedures or judged to be inappropriate for the study. 2. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of her/his participation in the study or is considered to be an imminent danger to her/himself or others, and/or: 1. At the Screening/Baseline Visit, the patient scores yes on Suicidal Ideation Items 4 or 5 of the C SSRS Since Last Visit version; 2. At the Screening/Baseline visit, the patient scores ≥ 5 on the MADRS Item 10 (Suicidal Thoughts). 3. Based on the Investigator's clinical judgement, any abnormal clinical laboratory test or ECG results obtained throughout the lead-in study that are considered clinically significant and preclude safe participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number and Percentage of Patients Reporting Treatment Emergent Adverse Events | 26 weeks | An AE that occurs during the Open-label Treatment Period will be considered a treatment-emergent AE (TEAE) if it was not present before the date of the first dose of open-label lumateperone or was present before the date of the first dose of open-label lumateperone but changed in severity during the Open-label Treatment Period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in One of the 6 Week Double-blind Lead-in Studies (NCT04985942 & NCT05061706) to the End of the Open-Label Treatment Period (a Combined Total of up to 32 Weeks) in the Montgomery-Åsberg Depression Rating Scale | 32 weeks | The MADRS 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. |
| Change From Baseline in One of the 6 Week Double-blind Lead-in Studies (NCT04985942 & NCT05061706) to the End of the Open-Label Treatment Period (a Combined Total of up to 32 Weeks) in the Clinical Global Impression Scale-Severity | 32 weeks | The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not ta all ill) to 7 (among the most extremely ill patients). |
Countries
Bulgaria, Czechia, Finland, Germany, Hungary, India, Poland, Slovakia, South Korea, Sweden, United States
Participant flow
Pre-assignment details
812 patients were enrolled; 809 patients received at least one dose of study drug and included in the Safety Population.
Participants by arm
| Arm | Count |
|---|---|
| Lumateperone 42 mg Lumateperone: Lumateperone 42 mg capsules administered orally, once daily | 809 |
| Total | 809 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 60 |
| Overall Study | Death | 1 |
| Overall Study | Lack of Efficacy | 7 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Protocol Violation | 8 |
| Overall Study | Site Closure | 2 |
| Overall Study | Withdrawal by Subject | 41 |
Baseline characteristics
| Characteristic | Lumateperone 42 mg |
|---|---|
| Age, Continuous | 46.2 years STANDARD_DEVIATION 12.22 |
| Race/Ethnicity, Customized Asian | 61 Participants |
| Race/Ethnicity, Customized Black or African American | 37 Participants |
| Race/Ethnicity, Customized Multiple | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Race/Ethnicity, Customized White | 703 Participants |
| Region of Enrollment Argentina | 56 participants |
| Region of Enrollment Bulgaria | 159 participants |
| Region of Enrollment Czechia | 95 participants |
| Region of Enrollment Germany | 25 participants |
| Region of Enrollment Hungary | 15 participants |
| Region of Enrollment India | 53 participants |
| Region of Enrollment Poland | 147 participants |
| Region of Enrollment Slovakia | 32 participants |
| Region of Enrollment Sweden | 2 participants |
| Region of Enrollment United States | 225 participants |
| Sex: Female, Male Female | 549 Participants |
| Sex: Female, Male Male | 260 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 809 |
| other Total, other adverse events | 322 / 809 |
| serious Total, serious adverse events | 8 / 809 |
Outcome results
Primary
The Number and Percentage of Patients Reporting Treatment Emergent Adverse Events
An AE that occurs during the Open-label Treatment Period will be considered a treatment-emergent AE (TEAE) if it was not present before the date of the first dose of open-label lumateperone or was present before the date of the first dose of open-label lumateperone but changed in severity during the Open-label Treatment Period.
Time frame: 26 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lumateperone 42 mg | The Number and Percentage of Patients Reporting Treatment Emergent Adverse Events | 548 Participants |
Secondary
Change From Baseline in One of the 6 Week Double-blind Lead-in Studies (NCT04985942 & NCT05061706) to the End of the Open-Label Treatment Period (a Combined Total of up to 32 Weeks) in the Clinical Global Impression Scale-Severity
The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not ta all ill) to 7 (among the most extremely ill patients).
Time frame: 32 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lumateperone 42 mg | Change From Baseline in One of the 6 Week Double-blind Lead-in Studies (NCT04985942 & NCT05061706) to the End of the Open-Label Treatment Period (a Combined Total of up to 32 Weeks) in the Clinical Global Impression Scale-Severity | -2.5 score on a scale | Standard Deviation 1.19 |
Secondary
Change From Baseline in One of the 6 Week Double-blind Lead-in Studies (NCT04985942 & NCT05061706) to the End of the Open-Label Treatment Period (a Combined Total of up to 32 Weeks) in the Montgomery-Åsberg Depression Rating Scale
The MADRS 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.
Time frame: 32 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lumateperone 42 mg | Change From Baseline in One of the 6 Week Double-blind Lead-in Studies (NCT04985942 & NCT05061706) to the End of the Open-Label Treatment Period (a Combined Total of up to 32 Weeks) in the Montgomery-Åsberg Depression Rating Scale | -21.7 score on a scale | Standard Deviation 8.39 |