Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2026-04-19 @ 12:45 AM
Study NCT ID:
NCT02934334
Status:
COMPLETED
Last Update Posted:
2020-11-04
First Post:
2016-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wellness Monitoring for Major Depressive Disorder
Sponsor:
Sidney Kennedy
Organization:
Study Overview
Official Title:
A Collaborative Investigation of Predictors of Relapse in Major Depressive Disorder: CAN-BIND-1 Extension Study
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CBN-Well
Brief Summary:
The Wellness Monitoring for Major Depressive Disorder (MDD) study is a prospective, longitudinal, observational study aimed at identifying biomarkers of relapse in MDD. Results may help refine clinical approach to relapse management, and may ultimately help MDD patients sustain wellness while on antidepressant medication.
Detailed Description:
This study involves a naturalistic follow up of responders from the study entitled "Integrated biological markers for the prediction of treatment response in depression", or the CAN-BIND-1 study. In addition, this study is also open to other participants who completed other CAN-BIND studies, as well as remitters who meet the inclusion criteria. Since patients usually seek medical attention only after relapse has occurred, imminent precursors to relapse are not well known. In this study, participants who are currently responding to an oral antidepressant treatment regimen and/or therapeutic intervention will be monitored over a minimum period of 13 months, which provides a unique opportunity to discover near-term biomarkers of relapse.
The study is conducted in partnership with Janssen Research \& Development and utilizes remote monitoring technology for data gathering.
The study is conducted in partnership with Janssen Research \& Development and utilizes remote monitoring technology for data gathering.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: