Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and tolerability of brexpiprazole as adjunctive treatment in an elderly population with major depressive disorder and an inadequate response to antidepressant treatment

Official Title
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Interventional, Open-label, Flexible-dose, Long-term Study to Evaluate the Safety and Tolerability of Brexpiprazole as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment

Conditions
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Major Depression Disorder

Intervention / Treatment
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* Drug: Adjunct brexpiprazole
* Drug: ADT


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: • The patient is a man or woman aged ≥65 yrs The patient has Major Depressive Disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR™). The patient has an inadequate response to at least one adequate antidepressant treatment in the current Major Depressive Episode (MDE). The patient has had the current MDE for ≥8 weeks The patient is currently treated with a protocol specified ADT for at least 6 weeks The patient is judged to benefit from adjunctive treatment with brexpiprazole according to the clinical opinion of the investigator. Montgomery and Åsberg Depression Rating Scale (MADRS) total score > 18 at screening and baseline Clinical Global Impression - Severity (CGI-S) total score ≥3 at screening and baseline Main Exclusion Criteria: • The patient has a clinically significant unstable illness The patient has newly diagnosed or unstable diabetes The patient has a Mini Mental State Exam (MMSE) score <24 The patient has received Transcranial Magnetic Stimulation (TMS) and/or electroconvulsive therapy (ECT) less than 6 months prior to the Screening. The patient, in the opinion of the investigator or based on Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation and behaviour rating, is at significant risk of suicide Other protocol defined inclusion and exclusion criteria may apply

Ages Eligible for Study
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Minimum 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: Adjunct brexpiprazole<br>All patients continue their current antidepressant treatment (ADT) and receive brexpiprazole in addition | Drug: Adjunct brexpiprazole<br>* Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily. Tablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg.<br>Drug: ADT<br>* Citalopram, ecitalopram, fluoxetine, sertraline, paroxetine IR, paroxetine CR, venlafaxine IR, venlafaxine XR (extended release), desvenlafaxine, duloxetine, mirtazapine, agomelatine, bupropion; dosing according to label<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Treatment-Emergent Adverse Events | Treatment-emergent adverse event is an adverse event that started or increased in intensity at or after baseline visit | Baseline to 30 weeks |