An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Lumateperone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In the opinion of the Investigator, patients must have safely completed the lead-in study. Patient is taking their ADT as prescribed from the lead-in study. Exclusion Criteria: In the opinion of the Investigator, the patient is unable to comply with study procedures or judged to be inappropriate for the study. 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: At the Screening/Baseline Visit, the patient scores yes on Suicidal Ideation Items 4 or 5 of the C SSRS Since Last Visit version; At the Screening/Baseline visit, the patient scores ≥ 5 on the MADRS Item 10 (Suicidal Thoughts). 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumateperone 42 mg<br> | Drug: Lumateperone<br>* Lumateperone 42 mg capsules administered orally, once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 26 weeks | 
| 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). | 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adjunctive MDD Therapy