Study to Evaluate Potential Predictors of Relapse in Participants With Major Depressive Disorder (MDD)



Status:Completed
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 64
Updated:10/28/2018
Start Date:December 15, 2014
End Date:May 1, 2018

Use our guide to learn which trials are right for you!

A Prospective, Longitudinal, Observational Study to Evaluate Potential Predictors of Relapse in Subjects With Major Depressive Disorder Who Have Responded to Antidepressant Treatment

The purpose of this study is to identify if there are self-reported or objective measures
related to mood parameters that can predict near-term relapse (within 1 month or at another
identified time point before meeting the criteria for relapse) or early symptomatic changes
indicative of relapse prodrome in major depressive disorder (MDD).

This is a prospective, multicenter, longitudinal, single-cohort, observational study in
participants with MDD who have responded to, and are continuing to respond to and receive, an
oral antidepressant treatment regimen. The study will consist of 2 parts: a screening phase
of up to 2 weeks, and an observational phase of variable duration.

Inclusion Criteria:

- Participants must have met Diagnostic and Statistical Manual of Mental Disorders-5th
edition (DSM-V) criteria for diagnosis of nonpsychotic MDD within the past 2 years
(that is, the start of the most recent major depressive episode (MDE) must be less
than or equal to 24 Months before screening), as confirmed using the MINI
International Neuropsychiatric Interview (MINI - DSM-V). MDD must be recurrent, rather
than a single episode

- During the most recent MDE, participant must have responded to, and must be continuing
to receive and respond to, an oral antidepressant treatment regimen (given at an
adequate dosage and duration based on the Massachusetts General Hospital
Antidepressant Treatment Response Questionnaire), within the past 3 months. A change
in the oral antidepressant treatment regimen since the time of achieving response in
the most recent episode will be allowed

- Participants must have a Montgomery Asberg Depression Rating Scale total score less
than or equal to 14

- Participant must be willing and able to complete self-reported assessments via a
study-specific smartphone, and must be willing to wear an wrist actigraphy device for
the duration of the study

Exclusion Criteria:

- Participant has any of the following DSM-V psychiatric diagnoses: MDD with psychotic
features (lifetime), bipolar disorder (including lifetime diagnosis), schizophrenia,
or schizoaffective disorder

- Participant has a history of drug or alcohol use, with a severity of at least moderate
or severe, according to DSM-V criteria, within 6 months before screening

- Participant is currently receiving or has received vagal nerve stimulation (VNS),
electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) or deep
brain stimulation (DBS) for the most recent MDE

- Participant is currently receiving stimulants, anticonvulsants, or mood stabilizers
for treatment of his or her MDD

- Participant is a woman who is pregnant, or planning to become pregnant, while enrolled
in this study
We found this trial at
25
sites
328
mi
from 91732
Stanford, CA
Click here to add this to my saved trials
1932
mi
from 91732
Ann Arbor, MI
Click here to add this to my saved trials
2053
mi
from 91732
Augusta, GA
Click here to add this to my saved trials
1784
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
Charleston, South Carolina 29412
2184
mi
from 91732
Charleston, SC
Click here to add this to my saved trials
1729
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
1880
mi
from 91732
Cincinnati, OH
Click here to add this to my saved trials
1225
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
2202
mi
from 91732
Durham, NC
Click here to add this to my saved trials
13
mi
from 91732
Glendale, CA
Click here to add this to my saved trials
2497
mi
from 91732
Hartford, CT
Click here to add this to my saved trials
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
1528
mi
from 91732
Iowa City, IA
Click here to add this to my saved trials
2127
mi
from 91732
Jacksonville, FL
Click here to add this to my saved trials
73
mi
from 91732
Oceanside, CA
Click here to add this to my saved trials
2182
mi
from 91732
Orlando, FL
Click here to add this to my saved trials
2375
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
570
mi
from 91732
Salt Lake City, UT
Click here to add this to my saved trials
105
mi
from 91732
San Diego, CA
Click here to add this to my saved trials
26
mi
from 91732
Sherman Oaks, CA
Click here to add this to my saved trials
1724
mi
from 91732
Skokie, IL
Click here to add this to my saved trials
1606
mi
from 91732
Springfield, IL
Click here to add this to my saved trials
2136
mi
from 91732
Tampa, FL
Click here to add this to my saved trials
1182
mi
from 91732
Wichita, KS
Click here to add this to my saved trials
2540
mi
from 91732
Worcester, MA
Click here to add this to my saved trials