NCT02400346

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Major Depression Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2015-03-27
• Last updated: 2017-08-10
• Results posted: 2017-06-26

Locations

34 sites across 5 countries: United States, Estonia, Finland, Germany, Poland