NCT06746155

Predictors of Relapse in Major Depressive Disorder

Predictors of Early Relapse During Follow-up of Remitted Major Depression

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 252 (estimated)
• Sponsor: Abraham Nunes · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Major depressive disorder (MDD) is a common condition involving recurring periods of depression. One of the major challenges faced by people with MDD is that the episodes of depression tend to recur even after they are successfully treated. Currently, it is hard to predict when a depressive episode will recur. Being able to forecast this would help healthcare providers monitor patients and prevent relapse. The purpose of this study is to monitor features such as clinical symptoms, physical activity, sleep patterns, cognitive functioning and brain activity to help us understand how relapse happens and the mechanisms that cause it. From these different types of data, investigators will build a model that tells us who is more likely to experience a relapse and when the relapse is likely to occur. This study will be a significant step forward in understanding and managing MDD. Investigator will create a practical tool that will allow healthcare providers to monitor patients more effectively. By identifying early signs of relapse, investigators may be able to intervene promptly to prevent depressive episodes. Finally, our research will help understand the factors that underlie relapse in MDD, which will encourage the development of novel treatment approaches.

Detailed description

This study is a multi-centre prospective naturalistic observational cohort study. Participants will be enrolled and followed for 18 months since enrollment. This study will be conducted across nine Canadian clinical-academic sites (Vancouver, Calgary, Hamilton, Toronto Western Hospital, Toronto-Center for Addiction and Mental Health \[CAMH\], Kingston, Ottawa, Ontario Shores and Halifax), which are currently enrolling participants for the OPTIMUM-D study (NCT05017311). For the present study, participants will be recruited from each of these sites, focusing on OPTIMUM-D participants who attain broadly-defined remission. Participants will wear a GENEActiv accelerometer (Activinsights; motion tracker) on the non-dominant wrist for the duration of the study. Participants will rate their depression by completing the Quick Inventory of Depressive Symptoms 16-item Self-Rated Version (QIDS-16SR) and anxiety by completing the Generalized Anxiety Disorder 7-item (GAD-7) at weekly interval throughout the study. Participants will have bi-monthly in-person follow-up assessments to rate their depressive symptom severity using the Montgomery-Asberg depression Rating Scale (MADRS). Speech and Electroencephalography (EEG) will be collected bi-monthly, and at the time of relapse.

Conditions

• Major Depressive Disorder (MDD)

Timeline

• Start date: 2024-10-11
• Primary completion: 2028-10-01
• Completion: 2029-10-01
• First posted: 2024-12-24
• Last updated: 2024-12-24

Locations

1 site across 1 country: Canada