- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02489305
Study to Evaluate Potential Predictors of Relapse in Participants With Major Depressive Disorder (MDD)
October 25, 2018 updated by: Janssen Research & Development, LLC
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).
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
330
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States
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California
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Glendale, California, United States
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Oceanside, California, United States
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San Diego, California, United States
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Sherman Oaks, California, United States
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Stanford, California, United States
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Connecticut
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Hartford, Connecticut, United States
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Florida
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Jacksonville, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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Georgia
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Augusta, Georgia, United States
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Illinois
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Chicago, Illinois, United States
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Skokie, Illinois, United States
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Springfield, Illinois, United States
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Iowa
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Iowa City, Iowa, United States
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Kansas
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Wichita, Kansas, United States
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Massachusetts
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Worcester, Massachusetts, United States
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Michigan
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Ann Arbor, Michigan, United States
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North Carolina
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Durham, North Carolina, United States
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Ohio
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Cincinnati, Ohio, United States
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Pennsylvania
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Philadelphia, Pennsylvania, United States
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South Carolina
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Charleston, South Carolina, United States
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Texas
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Dallas, Texas, United States
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Houston, Texas, United States
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Utah
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Salt Lake City, Utah, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants with major depressive disorder who have responded to an oral antidepressant regimen will be observed.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Near Term Relapse
Time Frame: Baseline up to end of study (8 Weeks)
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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.
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Baseline up to end of study (8 Weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2014
Primary Completion (Actual)
May 1, 2018
Study Completion (Actual)
May 1, 2018
Study Registration Dates
First Submitted
July 1, 2015
First Submitted That Met QC Criteria
July 1, 2015
First Posted (Estimate)
July 3, 2015
Study Record Updates
Last Update Posted (Actual)
October 26, 2018
Last Update Submitted That Met QC Criteria
October 25, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR105160
- OBSERVEMDD0001 (Other Identifier: Janssen Research & Development, LLC)
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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