Understanding relapse in major depressive disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify predictors of relapse in individuals with major depressive disorder (MDD) by monitoring various factors such as clinical symptoms, physical activity, sleep patterns, cognitive functioning, and brain activity over an 18-month period. Participants will wear a motion tracker and complete self-reported assessments weekly, while also undergoing bi-monthly follow-ups to evaluate their depressive symptoms. The goal is to develop a predictive model that can help healthcare providers anticipate and prevent relapse in patients who have achieved remission.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Outpatients 18 to 70 years of age.
* Meet DSM-V criteria for MDD as determined by the SCID-5 or other standardized clinical interviews.
* 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. Patients must have achieved remission at or later than May 1, 2023.
* 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:

* Bipolar I or Bipolar-II diagnosis (lifetime), schizophrenia, or schizoaffective disorder.
* 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.

Where it's running

• University of Calgary
  Calgary, Alberta, Canada Recruiting
• University of British Columbia
  Vancouver, British Columbia, Canada Recruiting
• Nova Scotia Health
  Halifax, Nova Scotia, Canada Recruiting
• McMaster University
  Hamilton, Ontario, Canada Recruiting
• Queen's University
  Kingston, Ontario, Canada Recruiting
• Centre for Addiction and Mental Health (CAMH)
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Vanessa Pardo, BA (Hons)
• Email: CPSY@nshealth.ca
• Phone: 902-473-2697

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• EEG-Guided TMS for Adults With Depression

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.