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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Major Depressive Disorder (MDD)

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 252

Contacts and Locations

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

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Recruiting
      • University of Calgary
      • Contact: University of Calgary; Phone Number: 403-210-7445; Email: canbind@ucalgary.ca
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Recruiting
      • University of British Columbia
      • Contact: University of British Columbia; Phone Number: 604-822-7804; Email: Lam.MDDResearch2@ubc.ca
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Recruiting
      • Nova Scotia Health
      • Contact: Vanessa Pardo, BA (Hons); Phone Number: 902-473-2697; Email: CPSY@nshealth.ca
      • Principal Investigator: Abraham Nunes, MD PhD MBA FRCPC
  • Ontario
    • Hamilton, Ontario, Canada
      • Recruiting
      • McMaster University
      • Contact: Phone Number: 39178 905-522-1155; Email: ehewitso@stjoes.ca
    • Kingston, Ontario, Canada
      • Recruiting
      • Queen's University
      • Contact: Queen's University; Email: canbind.optimumd@queensu.ca
    • Toronto, Ontario, Canada
      • Recruiting
      • University Health Network
      • Contact: University Health Network; Phone Number: 437-522-4953; Email: canbindstudies@uhn.ca
    • Toronto, Ontario, Canada
      • Recruiting
      • Centre for Addiction and Mental Health (CAMH)
      • Contact: Centre for Addiction and Mental Health (CAMH); Phone Number: 39574 416-535-8501; Email: amy.zhang@camh.ca
    • Whitby, Ontario, Canada
      • Recruiting
      • Ontario Shores Centre for Mental Health Sciences
      • Contact: Ontario Shores Centre for Mental Health Sciences; Phone Number: 6081 905-430-4055; Email: moodstudies@ontarioshores.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who participated in the OPTIMUM-D protocol, and who are currently in remission. Past participants from other CAN-BIND studies who meet current inclusion/exclusion criteria will also be approached for the present study. Other patients with MDD, currently in remission, who attend clinics at each of the study sites will also be considered for enrollment.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-to-relapse	In this study, relapse will be defined as any of the following: MADRS total score equal or greater than 22 for at least 2 consecutive weeks. If the relapse criterion of MADRS total score equal or greater than 22 is met at a study visit (scheduled or unscheduled), an additional visit (i.e., the Relapse Verification visit) will be scheduled 2 weeks later (± 5 days) to verify the relapse.; Hospitalization onto an inpatient acute care unit for worsening of depression.; Suicidal ideation with intent, or suicidal behavior plus at least one elevated MADRS total score of equal or greater than 22.; Change in antidepressant management undertaken for the purpose of managing emergent depressive symptoms.; Other factors deemed by clinician to be sufficient to denote relapse (the investigator will be asked to describe clinical rationale in this situation). Participants who relapse will continue to be followed in the study.	18 months

Collaborators and Investigators

• Sponsor: Abraham Nunes
• Collaborators: University Health Network, Toronto; University of British Columbia; Centre for Addiction and Mental Health; McMaster University; University of Calgary; Queen's University; Nova Scotia Health Authority; Ontario Shores Centre for Mental Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): December 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Biomarkers; Remission; Follow-up; Major Depressive Disorder; Relapse; Clinical predictors; Relapse prediction
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease Attributes; Mood Disorders; Depressive Disorder; Pathological Conditions, Signs and Symptoms; Recurrence; Depressive Disorder, Major
• Other Study ID Numbers: CAN-BIND-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No