Overview

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

Status:
Terminated
Trial end date:
2011-09-27
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Treatments:
Aripiprazole
Citalopram
Dexetimide
Criteria
Inclusion Criteria:

- Participants with a current diagnosis of a major depressive episode. The current
depressive episode must be ≥ 8 weeks in duration

- Participants willing to discontinue all prohibited psychotropic medication starting
from the time of signing the informed consent and during the study period

- Participants with a 17-item Hamilton Depression Rating Scale (HAM-D17) total score ≥
18 at the Baseline Visit for the Prospective Treatment Phase.

Exclusion Criteria:

- Lack of prior treatment with an antidepressant during the current depressive episode

- Participants who report treatment with adjunctive or monotherapy antipsychotic
treatment during the current depressive episode.

- Participants experiencing hallucinations, delusions or any psychotic symptomatology in
the current depressive episode

- Participants with epilepsy or significant history of seizure disorders

- Participants with a clinically significant current diagnosis of borderline,
antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder

- Participants who have received electroconvulsive therapy (ECT) in the last 10 years.