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Trial record 1 of 1 for:    NCT02489305
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Study to Evaluate Potential Predictors of Relapse in Participants With Major Depressive Disorder (MDD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02489305
Recruitment Status : Completed
First Posted : July 3, 2015
Last Update Posted : October 26, 2018
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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).

Condition or disease
Depressive Disorder, Major

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 330 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Participants With Major Depressive Disorder
Participants with major depressive disorder who have responded to oral antidepressant treatment will be observed over time.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with major depressive disorder who have responded to an oral antidepressant regimen will be observed.

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02489305

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United States, Alabama
Birmingham, Alabama, United States
United States, California
Glendale, California, United States
Oceanside, California, United States
San Diego, California, United States
Sherman Oaks, California, United States
Stanford, California, United States
United States, Connecticut
Hartford, Connecticut, United States
United States, Florida
Jacksonville, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
United States, Georgia
Augusta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
Skokie, Illinois, United States
Springfield, Illinois, United States
United States, Iowa
Iowa City, Iowa, United States
United States, Kansas
Wichita, Kansas, United States
United States, Massachusetts
Worcester, Massachusetts, United States
United States, Michigan
Ann Arbor, Michigan, United States
United States, North Carolina
Durham, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
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Study Director: Janssen Research & Development, LLC Clinical Trials Janssen Research & Development, LLC
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Responsible Party: Janssen Research & Development, LLC Identifier: NCT02489305    
Other Study ID Numbers: CR105160
OBSERVEMDD0001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen Research & Development, LLC:
Depressive Disorder, Major
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms