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
12
sites
Santa Clara, California 95051
2680
mi
from 02139
Santa Clara, CA
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Albany, New York
136
mi
from 02139
Albany, NY
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Atlanta, Georgia
934
mi
from 02139
Atlanta, GA
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Austin, Texas
1691
mi
from 02139
Austin, TX
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Birmingham, Alabama
1048
mi
from 02139
Birmingham, AL
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Centralia, Illinois
982
mi
from 02139
Centralia, IL
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Chevy Chase, Maryland 20815
390
mi
from 02139
Chevy Chase, MD
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Jeffersonville, Indiana
819
mi
from 02139
Jeffersonville, IN
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Kansas City, Kansas
1247
mi
from 02139
Kansas City, KS
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680
mi
from 02139
Lima, OH
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Little Rock, Arkansas
1254
mi
from 02139
Little Rock, AR
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Nashville, Tennessee
939
mi
from 02139
Nashville, TN
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