NCT01123707

To Assess the Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)

A Multicenter, 52-week, Open-label Study to Assess the Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients With Major Depressive Disorder

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 66 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, 52-week, open-label study designed to assess the safety and tolerability of an oral aripiprazole/escitalopram combination therapy in outpatients with major depressive disorder (MDD). Enrollment into the study will be from eligible participants who have completed participation in Protocol 31-08-255 \[NCT01111539\], 31-08-256 \[NCT01111552\], or 31-08-263 \[NCT01111565\] ("rollover" participants).

Conditions

• Major Depressive Disorder (MDD)

Interventions

Type	Name	Description
DRUG	Aripiprazole	Aripiprazole oral capsules
DRUG	Escitalopram	Escitalopram oral capsules

Timeline

• Start date: 2010-11-18
• Primary completion: 2011-09-27
• Completion: 2011-09-27
• First posted: 2010-05-14
• Last updated: 2021-12-22
• Results posted: 2021-12-22

Regulatory

• FDA-regulated drug study