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

NCT ID: NCT02489305

Last Updated: 2025-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

330 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-15

Study Completion Date

2018-05-01

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Depressive Disorder, Major

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trials

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Birmingham, Alabama, United States

Site Status

Glendale, California, United States

Site Status

Oceanside, California, United States

Site Status

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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Hartford, Connecticut, United States

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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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Augusta, Georgia, United States

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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 City, Iowa, United States

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Wichita, Kansas, United States

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Worcester, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Durham, North Carolina, United States

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Cincinnati, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Dallas, Texas, United States

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Houston, Texas, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36061300 (View on PubMed)

Other Identifiers

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OBSERVEMDD0001

Identifier Type: OTHER

Identifier Source: secondary_id

CR105160

Identifier Type: -

Identifier Source: org_study_id

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