NCT01838681

Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,986 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the long-term efficacy and safety of brexpiprazole as an adjunctive treatment to an antidepressant treatment (ADT) for adult patients with Major Depressive Disorder (MDD).

Detailed description

The total duration of the study was 32 weeks and the study consisted of Periods A, B, and A+. Patients entered the study in Period A and were treated open-label with one of six commercially available antidepressant treatments (ADTs) for 8 weeks. Patients who met the blinded response criteria at the Week 6 Visit, were deemed early responders and were withdrawn from the study. At Week 8, patients with inadequate response to placebo + ADT, as per the randomisation criteria, entered Period B and were randomised to received double-blind brexpiprazole + ADT or placebo + ADT for 24 weeks. Non-randomised patients continued in Period A+ and received placebo + ADT until the end of the study. The primary objective was to compare the efficacy and safety of brexpiprazole with placebo. This comparison occurred Period B; therefore, the focus is Period B.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Placebo	Once daily, tablets, orally
DRUG	Brexpiprazole	1, 2, or 3 mg/day, once daily dose, tablets, orally. Uptitration in weekly steps from 1 mg/day
DRUG	ADT	Duloxetine, escitalopram, fluoxetine, paroxetine IR, sertraline, venlafaxine XR; dosing according to label

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2013-04-24
• Last updated: 2017-08-09
• Results posted: 2017-08-09

Locations

107 sites across 16 countries: United States, Bulgaria, Canada, Estonia, Finland, Germany, Latvia, Lithuania, Mexico, Poland, Romania, Russia, South Korea, Sweden, Ukraine, United Kingdom