Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)

Major Depressive Disorder (MDD) Clinical Trial

Official title: A Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients With Major Depressive Disorder

Status Terminated

Clinical Trial Summary

This will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in participants with MDD who have demonstrated an incomplete response to a prospective trial of Escitalopram, and report a treatment history for the current MDD episode of an inadequate response to at least one and no more than three adequate trials of an approved antidepressant other than Escitalopram. An inadequate response is defined as less than a 50% reduction in depressive symptom severity as assessed by the participant's self-report on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ) and evaluated by the investigator as part of the participant's medical and psychiatric history. An adequate trial is defined as an antidepressant treatment for at least 6 weeks duration (or at least 3 weeks for combination treatments) at an approved dose as specified in the ATRQ.

Clinical Trial Description

The study will be organized as follows:

• Screening Phase

• Single-blind Prospective Treatment Phase

• Single-blind Continuation Phase (Responder) or Double-blind Randomization Phase (non-Responder)

• 30 day Post Treatment Follow-up

Assigned Interventions:

• Escitalopram monotherapy

• Aripiprazole/Escitalopram combination therapy

• Aripiprazole monotherapy ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder (MDD)

• NCT number: NCT01111539
• Study type: Interventional
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Status: Terminated
• Phase: Phase 3
• Start date: July 13, 2010
• Completion date: September 20, 2011