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

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT02489305

Collaborator

(none)

330

Enrollment

Locations

40.5

Actual Duration (Months)

13.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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 Design

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 :

Dec 15, 2014

Actual Primary Completion Date :

May 1, 2018

Actual Study Completion Date :

May 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Number of Participants With Near Term Relapse [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country
1	Birmingham	Alabama	United States
2	Glendale	California	United States
3	Oceanside	California	United States
4	San Diego	California	United States
5	Sherman Oaks	California	United States
6	Stanford	California	United States
7	Hartford	Connecticut	United States
8	Jacksonville	Florida	United States
9	Orlando	Florida	United States
10	Tampa	Florida	United States
11	Augusta	Georgia	United States
12	Chicago	Illinois	United States
13	Skokie	Illinois	United States
14	Springfield	Illinois	United States
15	Iowa City	Iowa	United States
16	Wichita	Kansas	United States
17	Worcester	Massachusetts	United States
18	Ann Arbor	Michigan	United States
19	Durham	North Carolina	United States
20	Cincinnati	Ohio	United States
21	Philadelphia	Pennsylvania	United States
22	Charleston	South Carolina	United States
23	Dallas	Texas	United States
24	Houston	Texas	United States
25	Salt Lake City	Utah	United States