NCT01111539

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Major Depressive Disorder (MDD)

Interventions

Type	Name	Description
DRUG	Escitalopram	Escitalopram capsule administered orally, once daily without regard to meals.
DRUG	Aripiprazole	Aripiprazole capsule administered orally, once daily without regard to meals.
DRUG	Blinded capsule	Blinded capsule administered orally, once daily.

Timeline

• Start date: 2010-07-13
• Primary completion: 2011-09-20
• Completion: 2011-09-20
• First posted: 2010-04-27
• Last updated: 2021-10-20
• Results posted: 2021-10-20

Locations

62 sites across 9 countries: United States, Estonia, Finland, Germany, India, Italy, Mexico, South Korea, Taiwan

Regulatory

• FDA-regulated drug study