NCT06746155 Predictors of Relapse in Major Depressive Disorder (PERFORM-D)

Eligibility & Interventions

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 252 participants in total. It began in 2024-12-27 with a primary completion date of 2028-10-01.

Brief 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 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.

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