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Study to Evaluate Potential Predictors of Relapse in Participants With Major Depressive Disorder (MDD)

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ClinicalTrials.gov Identifier: NCT02489305
Recruitment Status : Recruiting
First Posted : July 3, 2015
Last Update Posted : January 12, 2018
Sponsor:
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.

Study Type : Observational
Estimated 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
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
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

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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.
Criteria

Inclusion Criteria:

  • Participants must have met Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5) criteria for diagnosis of nonpsychotic MDD within the past 2 years (that is, the start of the current 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-5). MDD must be recurrent, rather than a single episode
  • In the current 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 current 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-5 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-5 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 current 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 ClinicalTrials.gov identifier (NCT number): NCT02489305


Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

  Show 28 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trials Janssen Research & Development, LLC

Additional Information:
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02489305     History of Changes
Other Study ID Numbers: CR105160
OBSERVEMDD0001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Research & Development, LLC:
Depressive Disorder, Major
Depression
Anti-Depressant
Observational

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms