Study Results
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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RECRUITING
252 participants
OBSERVATIONAL
2024-10-11
2029-10-01
Brief Summary
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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
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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
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Meet DSM-V criteria for MDD as determined by the SCID-5.
* In the current or most recent MDE, participant must be responding or responded to a treatment or a combination of treatments for MDD. Patients with remitted MDD who are currently not taking medications will also be accepted.
* Participants must have a MADRS total score ≤14.
* Participant must be willing and able to complete self-reported assessments including sufficient fluency in English.
* Participant must be willing to wear the wrist-worn actigraphic device for the duration of the study.
Exclusion Criteria
* Elevated risk of suicide, as determined by clinical evaluation.
* Existence of major neurological disorders, head injury (if accompanied by any of \[A\] loss of consciousness longer than 24 hours, \[B\] documented evidence of Glasgow Coma Scale \<9 at the time of injury, \[C\] post-traumatic amnesia lasting longer than 24 hours) (43), or other unstable medical conditions.
* The participant presents with any condition which, according to the researcher's judgment, could interfere with the assessments stipulated in the protocol.
* The participant is employed by the researcher, actively involved in the current study or other research overseen by the same researcher, or is a relative of a study employee or the researcher.
18 Years
70 Years
ALL
No
Sponsors
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McMaster University
OTHER
University of British Columbia
OTHER
University of Calgary
OTHER
Ontario Shores Centre for Mental Health Sciences
OTHER
Queen's University
OTHER
Nova Scotia Health Authority
OTHER
University Health Network, Toronto
OTHER
University of Ottawa
OTHER
Centre for Addiction and Mental Health
OTHER
Abraham Nunes
OTHER
Responsible Party
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Abraham Nunes
Psychiatrist/Assistant Professor
Locations
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Nova Scotia Health
Halifax, Nova Scotia, Canada
Countries
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Central Contacts
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Facility Contacts
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Vanessa Pardo, BA (Hons)
Role: primary
Abraham Nunes, MD PhD MBA FRCPC
Role: backup
Other Identifiers
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CAN-BIND-20
Identifier Type: -
Identifier Source: org_study_id