drugset
drugset / Trial / NCT01123707

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

NCT01123707 ↗

Phase 3 Terminated 173 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc.
Non-randomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2010-11-18
Primary completion
2011-09-27
Completion
2011-09-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Aripiprazole Other / unclassified 3 mg Oral
Subject Aripiprazole Other / unclassified 6 mg Oral
Subject Aripiprazole Other / unclassified 12 mg Oral
Subject Escitalopram Small molecule 10 mg Oral
Subject Escitalopram Small molecule 20 mg Oral

Indications

major depressive disorder