Trial of Centanafadine Efficacy and Safety as Monotherapy or as Adjunct to SSRI in Adults With Major Depressive Disorder

Study Overview
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Brief Summary
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This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-arm trial to assess the efficacy, safety, and tolerability of centanafadine once-daily (QD) extended-release (XR) capsules for the treatment of adult subjects diagnosed with Major Depressive Disorder (MDD). The trial will evaluate the efficacy and safety of centanafadine QD XR capsules as monotherapy or as adjunct to the selective serotonin reuptake inhibitor (SSRI), escitalopram.

Official Title
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A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Trial to Assess the Efficacy, Safety, and Tolerability of Centanafadine Extended-release Capsules as Monotherapy or as Adjunct to SSRI in Adult Subjects With Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Centanafadine
* Drug: Escitalopram
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Male and Female subjects between 18-65 years of age, with a primary diagnosis of major depressive disorder and in a current major depressive episode. History of an inadequate response to at least 1 and no more than 3 antidepressant treatments in the current major depressive episode. Key Exclusion Criteria: Subjects who report an inadequate response to more than 3 antidepressant treatments in the current episode. Subjects with a lifetime history of schizophrenia spectrum or other psychotic disorder, bipolar or related disorder, neurocognitive disorder, or personality disorder. Subjects with a current diagnosis of post-traumatic stress disorder, obsessive compulsive disorder, panic disorder, or eating disorder (including anorexia nervosa or bulimia). Sexually active subjects, who could become pregnant, not agreeing to practice 2 sponsor approved methods of birth control or remain abstinent during the trial and for 30 days (females) or 90 days (males) after last dose of study drug.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Centanafadine + Placebo<br> | Drug: Centanafadine<br>* capsule<br>Drug: Placebo<br>* capsule<br>|
| Experimental: Centanafadine + Escitalopram<br> | Drug: Centanafadine<br>* capsule<br>Drug: Escitalopram<br>* capsule<br>|
| Active Comparator: Escitalopram + Placebo<br> | Drug: Escitalopram<br>* capsule<br>Drug: Placebo<br>* capsule<br>|
| Placebo Comparator: Placebo + Placebo<br> | Drug: Placebo<br>* capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total score. |  | Baseline, Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MDD, Centanafadine, SSRI, Depressive Disorder, Depression, Depressive Disorder, Major, Mood Disorders, Mental Disorders, Behavioral Symptoms