Study of Adjunctive or Monotherapy Rapastinel Treatment in Patients With Major Depressive Disorder (MDD)

Study Overview
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Brief Summary
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Multicenter, open-label, long-term extended access treatment protocol in adult patients with a primary diagnosis of MDD.

Official Title
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An Open-label, Long-term Extended Access Protocol for Rapastinel as Adjunctive or Monotherapy Treatment in Patients With Major Depressive Disorder

Conditions
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Depressive Disorder, Major

Intervention / Treatment
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* Drug: Rapastinel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completion of lead-in study Adequate therapeutic benefit in the lead-in study to justify continuation of treatment with rapastinel in the judgement of the investigator Exclusion Criteria: Suicide risk, as determined by meeting any of the following criteria: A suicide attempt within the past year Significant risk, as judged by the investigator, based on the psychiatric interview or information collected in the Columbia- Suicide Severity Rating Scale (C-SSRS) at any visit in the lead-in study Montgomery-Asberg Depression Rating Scale (MADRS) Item 10 score ≥ 5 at any visit during participation in the lead-in study where MADRS was conducted. At imminent risk of injuring self or others or causing significant damage to property, as judged by the investigator Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during participation Females of childbearing potential and male partners of females of childbearing potential, not using a reliable means of contraception

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Rapastinel<br>Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration) | Drug: Rapastinel<br>* Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Count of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs) | A Treatment Emergent Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded. | Up to 45 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression