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

H. Lundbeck A/S34 sites in 5 countries132 target enrollmentMarch 2015

ConditionsMajor Depression Disorder

InterventionsAdjunct brexpiprazole ADT

Overview

Phase: Phase 3
Intervention: Adjunct brexpiprazole
Conditions: Major Depression Disorder
Sponsor: H. Lundbeck A/S
Enrollment: 132
Locations: 34
Primary Endpoint: Number of Patients With Treatment-Emergent Adverse Events
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

March 2015

End Date

June 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

H. Lundbeck A/S

Responsible Party

Sponsor

Eligibility Criteria

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

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