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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2016

Interventions

  • Drug: Adjunct brexpiprazole
    • 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.
  • Drug: ADT
    • Citalopram, ecitalopram, fluoxetine, sertraline, paroxetine IR, paroxetine CR, venlafaxine IR, venlafaxine XR (extended release), desvenlafaxine, duloxetine, mirtazapine, agomelatine, bupropion; dosing according to label

Arms, Groups and Cohorts

  • Experimental: Adjunct brexpiprazole
    • All patients continue their current antidepressant treatment (ADT) and receive brexpiprazole in addition

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • H. Lundbeck A/S
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Email contact via H. Lundbeck A/S, Study Director, LundbeckClinicalTrials@Lundbeck.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.