NCT01837797

Efficacy and Safety of Brexpiprazole as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment

Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study to Evaluate the Efficacy and Safety of Brexpiprazole (1 and 3 mg/Day) as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of brexpiprazole as adjunctive treatment in elderly patients with Major Depressive Disorder (MDD)

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Placebo	Once daily, tablets, orally
DRUG	Brexpiprazole 1 mg	once daily dose, tablets, orally
DRUG	Brexpiprazole 3 mg	once daily dose, tablets, orally

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2013-04-23
• Last updated: 2018-10-17
• Results posted: 2016-03-03

Locations

2 sites across 1 country: United States