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

NCT01111539 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2021-10-20

Study results available
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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.

Conditions

  • Major Depressive Disorder (MDD)

Interventions

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.

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-13
Primary Completion
2011-09-20
Completion
2011-09-20
FDA Drug
Yes

Countries

  • United States
  • Estonia
  • Finland
  • Germany
  • India
  • Italy
  • Mexico
  • South Korea
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01111539 on ClinicalTrials.gov