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

Lundbeck

Status and phase: Completed; Phase 3

Conditions: Major Depression Disorder

Treatments: Drug: ADT; Drug: Adjunct brexpiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT02400346

16160A

2014-003547-35 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 132 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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132 participants in 1 patient group

Adjunct brexpiprazole

Experimental group

Description:

All patients continue their current antidepressant treatment (ADT) and receive brexpiprazole in addition

Treatment:

Drug: ADT

Drug: Adjunct brexpiprazole