Actively Recruiting
Predictors of Early Relapse During Follow-up of Remitted Major Depression A Study Observing Clinical, Activity, Sleep, Cognitive, and Brain Features to Forecast Relapse
Led by Abraham Nunes · Updated on 2024-12-24
252
Participants Needed
1
Research Sites
259 weeks
Total Duration
On this page
Sponsors
A
Abraham Nunes
Lead Sponsor
M
McMaster University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Major Depressive Disorder (MDD) is a common condition characterized by recurring episodes of depression. One challenge for people with MDD is that depressive episodes often come back even after treatment. This research aims to monitor various features such as symptoms, physical activity, sleep, thinking abilities, and brain activity to better understand how and why relapses happen. The study will help develop a tool to predict who might relapse and when, which could improve monitoring and prevention of future episodes. The study is a naturalistic observational cohort conducted across nine Canadian clinical sites. Participants will be followed for 18 months after enrollment. They will wear a wrist device called the GENEActiv accelerometer to track movement during the entire study. Weekly self-assessments of depression and anxiety symptoms will be completed using the QIDS-16SR and GAD-7 questionnaires. Every two months, participants will have in-person visits to measure depression severity with the MADRS scale. Speech samples and brain activity recordings using EEG will be collected every two months and if relapse occurs. Participants will be involved in regular symptom rating and physical activity monitoring throughout the 18-month period. Researchers will collect and analyze data on depression symptoms, anxiety, speech, and brain function to understand relapse mechanisms. The main outcome measured is the time until relapse within 18 months. This study aims to provide meaningful insights to help healthcare providers identify early signs of relapse and improve care for individuals with MDD.
CONDITIONS
Official Title
Predictors of Relapse in Major Depressive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Outpatients 18 to 70 years of age
- Meet DSM-V criteria for Major Depressive Disorder as determined by SCID-5
- Currently responding or responded to treatment for a major depressive episode, or in remission without medication
- Montgomery-Asberg Depression Rating Scale (MADRS) total score of 14 or less
- Willing and able to complete self-reported assessments with sufficient English fluency
- Willing to wear a wrist-worn activity device for the study duration
You will not qualify if you...
- Diagnosis of Bipolar I or Bipolar-II disorder, schizophrenia, or schizoaffective disorder
- Elevated risk of suicide as determined by clinical evaluation
- Major neurological disorders or significant head injury with loss of consciousness over 24 hours, Glasgow Coma Scale less than 9, or post-traumatic amnesia over 24 hours
- Any unstable medical condition
- Any condition that could interfere with study assessments as judged by the researcher
- Employment by the researcher, active involvement in this study or related research, or being a relative of a study employee or the researcher
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Trial Site Locations
Total: 1 location
1
Nova Scotia Health
Halifax, Nova Scotia, Canada
Actively Recruiting
Research Team
V
Vanessa Pardo, BA (Hons)
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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