Study to Assess the Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (MDD)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of NBI-1065845 compared with placebo in participants with MDD on improving symptoms of depression.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-1065845 in Adult Subjects With Major Depressive Disorder (MDD)

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Placebo
* Drug: NBI-1065845


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Participants must meet all of these criteria for inclusion in the study: The participant has completed written informed consent. At the time of signing the informed consent, participant must be 18 to 65 years of age, inclusive. The participant has a primary diagnosis of recurrent Major Depressive Disorder (MDD) or persistent depressive disorder. Participant must have had inadequate response to antidepressant treatment. Participant must have a Total Hamilton Depression Rating Scale-17 Item (HAMD-17) score ≥ 22 at screening. Participants currently receiving pharmacological treatment for depression must have been taking current antidepressant medication(s) for ≥8 weeks prior to screening. Subjects not currently receiving pharmacologic treatment for depression must have received the most recent antidepressant medication(s) for ≥8 weeks in the current episode of depression. Participants must be willing and able to comply with all study procedures. Key Exclusion Criteria: Participants will be excluded from the study if they meet any of the following criteria: Participant is pregnant or breastfeeding or plans to become pregnant during the study. Participant has an unstable medical condition or unstable chronic disease. Participant has a history of neurological abnormalities. Participant has a current or prior psychiatric disorder that was the primary focus of treatment other than MDD. The participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ECT). The participant has an alcohol or substance use disorder. In the Investigator's opinion, the participant is not capable of adhering to the protocol requirements.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants will receive placebo orally once a day. | Drug: Placebo<br>* Matching placebo tablets<br>|
| Experimental: NBI-1065845 Low Dose<br>Participants will receive low-dose NBI-1065845 orally once a day. | Drug: NBI-1065845<br>* NBI-1065845 tablets<br>* Other names: TAK-653;|
| Experimental: NBI-1065845 High Dose<br>Participants will receive high-dose NBI-1065845 orally once a day. | Drug: NBI-1065845<br>* NBI-1065845 tablets<br>* Other names: TAK-653;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Total Montgomery Åsberg Depression Rating Scale (MADRS) Score at Day 28 |  | Baseline, Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Total MADRS Score at Day 7, Day 14, and Day 56 |  | Baseline, Days 7, 14, and 56 | 
| Change from Baseline in Clinical Global Impression - Severity (CGI-S) Score at Day 28 and Day 56 |  | Baseline, Days 28 and 56 | 
| Response, defined as ≥50% decrease in MADRS from baseline, at Day 28 and Day 56 |  | Baseline, Days 28 and 56 | 
| Remission, defined as MADRS ≤10, at Days 28 and 56 |  | Days 28 and 56 | 
| Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score at Day 28 and Day 56 |  | Baseline, Days 28 and 56 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, MDD, Major Depressive Disorder, NBI-1065845, Mental Disorders, MADRS, SAVITRI, TAK-653