NCT01944969

Long-term Safety and Tolerability Study of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder

Interventional, Open-label, Long-term Extension Study to Evaluate the Safety and Tolerability of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the long-term safety and tolerability of brexpiprazole as adjunctive treatment in patients with Major Depressive Disorder (MDD)

Detailed description

This extension safety study was terminated early because one of the lead-in studies (14571A) in elderly was terminated and because the Sponsor considered that sufficient long-term safety data has already been collected in the development programme in the population aged 18-65 yrs.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Brexpiprazole	1, 2, or 3 mg/day, once daily dose, tablets, orally. Uptitration in weekly steps from 0.5 mg/day (patients ≥65) or 1 mg/day (patients 18-64 years)

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2013-09-18
• Last updated: 2018-10-17
• Results posted: 2016-03-03

Locations

1 site across 1 country: United States