Study to Evaluate Potential Predictors of Relapse in Participants With Major Depressive Disorder (MDD)
NCT ID: NCT02489305
Last Updated: 2025-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
330 participants
OBSERVATIONAL
2014-12-15
2018-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants With Major Depressive Disorder
Participants with major depressive disorder who have responded to oral antidepressant treatment will be observed over time.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
64 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trials
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Birmingham, Alabama, United States
Glendale, California, United States
Oceanside, California, United States
San Diego, California, United States
Sherman Oaks, California, United States
Stanford, California, United States
Hartford, Connecticut, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Augusta, Georgia, United States
Chicago, Illinois, United States
Skokie, Illinois, United States
Springfield, Illinois, United States
Iowa City, Iowa, United States
Wichita, Kansas, United States
Worcester, Massachusetts, United States
Ann Arbor, Michigan, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Dallas, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Countries
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References
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Li QS, Galbraith D, Morrison RL, Trivedi MH, Drevets WC. Circulating microRNA associated with future relapse status in major depressive disorder. Front Psychiatry. 2022 Aug 17;13:937360. doi: 10.3389/fpsyt.2022.937360. eCollection 2022.
Other Identifiers
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OBSERVEMDD0001
Identifier Type: OTHER
Identifier Source: secondary_id
CR105160
Identifier Type: -
Identifier Source: org_study_id
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