Study to Evaluate Potential Predictors of Relapse in Participants With Major Depressive Disorder (MDD)
A Prospective, Longitudinal, Observational Study to Evaluate Potential Predictors of Relapse in Subjects With Major Depressive Disorder Who Have Responded to Antidepressant Treatment
2 other identifiers
observational
330
1 country
25
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2014
Typical duration for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 15, 2014
CompletedFirst Submitted
Initial submission to the registry
July 1, 2015
CompletedFirst Posted
Study publicly available on registry
July 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedFebruary 3, 2025
January 1, 2025
3.4 years
July 1, 2015
January 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Near Term Relapse
Relapse will be defined as any of the following: a) MADRS total score greater than or equal to 22 on at least two consecutive visits, with an interval of 1-2 weeks; b) Hospitalization for worsening of depression; c) Suicidal ideation with intent, or suicidal behavior and d) Other (investigator will be asked to describe). MADRS total score ranges from 0 to 60, Higher scores represents a more severe condition.
Baseline up to end of study (8 Weeks)
Study Arms (1)
Participants With Major Depressive Disorder
Participants with major depressive disorder who have responded to oral antidepressant treatment will be observed over time.
Eligibility Criteria
Participants with major depressive disorder who have responded to an oral antidepressant regimen will be observed.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Glendale, California, United States
Unknown Facility
Oceanside, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Sherman Oaks, California, United States
Unknown Facility
Stanford, California, United States
Unknown Facility
Hartford, Connecticut, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Augusta, Georgia, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Skokie, Illinois, United States
Unknown Facility
Springfield, Illinois, United States
Unknown Facility
Iowa City, Iowa, United States
Unknown Facility
Wichita, Kansas, United States
Unknown Facility
Worcester, Massachusetts, United States
Unknown Facility
Ann Arbor, Michigan, United States
Unknown Facility
Durham, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Related Publications (1)
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.
PMID: 36061300DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trials
Janssen Research & Development, LLC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2015
First Posted
July 3, 2015
Study Start
December 15, 2014
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
February 3, 2025
Record last verified: 2025-01