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

Status:	Archived
Conditions:	Depression, Major Depression Disorder (MDD)
Therapuetic Areas:	Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	July 2010
End Date:	November 2013

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

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 subjects
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 subject's self-report on the
Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ) and
evaluated by the investigator as part of the subject'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.

The study will be organized as follows:

- Phase A (Screening Phase)

- Phase B (Single-blind Prospective Treatment Phase)

- Phase B+ (Single-blind Phase B Responder)

- Phase C (Double-blind Randomization Phase)

- Follow-up

Assigned Interventions:

- Phase B and Phase B+: Escitalopram monotherapy (10 mg or 20 mg)

- Phase C: Aripiprazole/Escitalopram combination therapy (3 mg/10 mg, 3 mg/20 mg, 6 mg/10
mg, 6 mg/20 mg, 12 mg/10 mg or 12 mg/20 mg); Aripiprazole monotherapy (3 mg, 6 mg or 12
mg); or Escitalopram monotherapy (10 mg or 20 mg)

We found this trial at

sites

Clinical Trial Facility

Boston, Massachusetts

from

Boston, MA