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

ClinicalTrials.gov ID: NCT01111539

Public ClinicalTrials.gov record NCT01111539. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT01111539
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 3
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.; Industry
Enrollment: 211 participants

Conditions and interventions

Conditions

Major Depressive Disorder (MDD)

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years to 65 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 13, 2010 (Actual)
Primary completion: Sep 20, 2011 (Actual)
Completion: Sep 20, 2011 (Actual)
Last update posted: Oct 20, 2021

2010 – 2011

United States locations

U.S. sites: 24
U.S. states: 14
U.S. cities: 24

Facility	City	State	ZIP	Site status
Not listed	Cerritos	California	90703	—
Not listed	Costa Mesa	California	92626	—
Not listed	Irvine	California	92618	—
Not listed	San Diego	California	92102	—
Not listed	Santa Ana	California	92705	—
Not listed	Denver	Colorado	80204	—
Not listed	Cromwell	Connecticut	06416	—
Not listed	Hartford	Connecticut	06106	—
Not listed	Fort Walton Beach	Florida	32547	—
Not listed	Gainesville	Florida	32607	—
Not listed	Chicago	Illinois	60612	—
Not listed	Libertyville	Illinois	60048	—
Not listed	Boston	Massachusetts	02114	—
Not listed	Fall River	Massachusetts	02721	—
Not listed	Albuquerque	New Mexico	87109	—
Not listed	Fresh Meadows	New York	11366	—
Not listed	Staten Island	New York	10305	—
Not listed	The Bronx	New York	10467	—
Not listed	Cary	North Carolina	27518	—
Not listed	Oklahoma City	Oklahoma	73112	—
Not listed	Memphis	Tennessee	38119	—
Not listed	DeSoto	Texas	75115	—
Not listed	Richmond	Virginia	23230	—
Not listed	Brown Deer	Wisconsin	53223	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 38 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01111539, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 20, 2021 · Synced Nov 5, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01111539 live on ClinicalTrials.gov.

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