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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorAbraham Nunes

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
18 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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Abraham Nunes

Lead sponsor

Nova Scotia Health Authority

Sponsor institution

McMaster University

Collaborator

University of British Columbia

Collaborator

University of Calgary

Collaborator

Ontario Shores Centre for Mental Health Sciences

Collaborator

Queen's University

Collaborator

Nova Scotia Health Authority

Collaborator

University Health Network, Toronto

Collaborator

Centre for Addiction and Mental Health

Collaborator