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

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 design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Sponsors and collaborators

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