Study to Evaluate Potential Predictors of Relapse in Participants With Major Depressive Disorder (MDD)
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|ClinicalTrials.gov Identifier: NCT02489305|
Recruitment Status : Completed
First Posted : July 3, 2015
Last Update Posted : September 24, 2018
|Condition or disease|
|Depressive Disorder, Major|
|Study Type :||Observational|
|Actual Enrollment :||364 participants|
|Official Title:||A Prospective, Longitudinal, Observational Study to Evaluate Potential Predictors of Relapse in Subjects With Major Depressive Disorder Who Have Responded to Antidepressant Treatment|
|Actual Study Start Date :||December 15, 2014|
|Actual Primary Completion Date :||May 1, 2018|
|Actual Study Completion Date :||May 1, 2018|
Participants With Major Depressive Disorder
Participants with major depressive disorder who have responded to oral antidepressant treatment will be observed over time.
- Number of Participants With Near Term Relapse [ Time Frame: Baseline up to end of study (8 Weeks) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02489305
Show 25 Study Locations
|Study Director:||Janssen Research & Development, LLC Clinical Trials||Janssen Research & Development, LLC|