Predictors of Relapse in Major Depressive Disorder (PERFORM-D)

Last updated: May 20, 2026
Sponsor: Abraham Nunes
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Treatment

N/A

Clinical Study ID

NCT06746155
CAN-BIND-20
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Outpatients 18 to 70 years of age.

  • Meet DSM-V criteria for MDD as determined by the SCID-5 or other standardizedclinical interviews.

  • In the current or most recent MDE, participant must be responding or responded to atreatment or a combination of treatments for MDD. Patients with remitted MDD who arecurrently not taking medications will also be accepted. Patients must have achievedremission 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 includingsufficient fluency in English.

  • Participant must be willing to wear the wrist-worn actigraphic device for theduration of the study.

Exclusion

Exclusion Criteria:

  • Bipolar I or Bipolar-II diagnosis (lifetime), schizophrenia, or schizoaffectivedisorder.

  • 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 ComaScale <9 at the time of injury, [C] post-traumatic amnesia lasting longer than 24hours) (43), or other unstable medical conditions.

  • The participant presents with any condition which, according to the researcher'sjudgment, could interfere with the assessments stipulated in the protocol.

  • The participant is employed by the researcher, actively involved in the currentstudy or other research overseen by the same researcher, or is a relative of a studyemployee or the researcher.

Study Design

Total Participants: 252
Study Start date:
December 27, 2024
Estimated Completion Date:
October 01, 2029

Study Description

This study is a multi-centre prospective naturalistic observational cohort study. Participants with MDD in remission will be enrolled and followed for 18 months since enrollment. This study will be conducted across eight Canadian clinical-academic sites (Vancouver, Calgary, Hamilton, Toronto Western Hospital, Toronto-Center for Addiction and Mental Health [CAMH], Kingston, 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 in-person follow-up assessments every two months to rate their depressive symptom severity using the Montgomery-Asberg depression Rating Scale (MADRS). Speech and Electroencephalography (EEG) will be collected every two months, and at the time of relapse.

Connect with a study center

  • University of Calgary

    Calgary, Alberta
    Canada

    Active - Recruiting

  • University of British Columbia

    Vancouver, British Columbia
    Canada

    Active - Recruiting

  • Nova Scotia Health

    Halifax, Nova Scotia
    Canada

    Active - Recruiting

  • McMaster University

    Hamilton, Ontario
    Canada

    Active - Recruiting

  • Queen's University

    Kingston, Ontario
    Canada

    Active - Recruiting

  • Centre for Addiction and Mental Health (CAMH)

    Toronto, Ontario
    Canada

    Active - Recruiting

  • University Health Network

    Toronto, Ontario
    Canada

    Active - Recruiting

  • Ontario Shores Centre for Mental Health Sciences

    Whitby, Ontario
    Canada

    Active - Recruiting

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