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

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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
14
sites
Santa Clara, California 95051
317
mi
from 91732
Santa Clara, CA
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Albany, New York
2440
mi
from 91732
Albany, NY
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Albuquerque, New Mexico
649
mi
from 91732
Albuquerque, NM
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Austin, Texas
1212
mi
from 91732
Austin, TX
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Boston, Massachusetts
2578
mi
from 91732
Boston, MA
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Celebration, Florida
2179
mi
from 91732
Celebration, FL
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Centralia, Illinois
1630
mi
from 91732
Centralia, IL
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Charlotte, North Carolina
2102
mi
from 91732
Charlotte, NC
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Denver, Colorado
817
mi
from 91732
Denver, CO
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Milwaukee, Wisconsin
1729
mi
from 91732
Milwaukee, WI
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Nashville, Tennessee
1763
mi
from 91732
Nashville, TN
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Newington, Connecticut
2495
mi
from 91732
Newington, CT
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Ponca City, Oklahoma
1190
mi
from 91732
Ponca City, OK
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Richmond, Virginia
2268
mi
from 91732
Richmond, VA
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