Recruiting

Observational Study

Sponsor:

Abraham Nunes

Code:

NCT06746155

Conditions

Major Depressive Disorder (MDD)

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Major Depressive Disorder (MDD)

Study ID

NCT06746155

Start date

Dec 27, 2024

Status verified date

Jul, 2026

Completion date

Oct 1, 2029

Anticipated

Primary completion date

Oct 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

252 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Time-to-relapse [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Vanessa Pardo, BA (Hons)

902-473-2697CPSY@nshealth.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada

Contacts

University of British Columbia

Recruiting

Vancouver, British Columbia, Canada

Contacts

University of British Columbia

604-822-7804Lam.MDDResearch2@ubc.ca

Nova Scotia Health

Recruiting

Halifax, Nova Scotia, Canada

Contacts

Vanessa Pardo, BA (Hons)

902-473-2697CPSY@nshealth.ca

Principal Investigator:

Abraham Nunes, MD PhD MBA FRCPC

McMaster University

Recruiting

Hamilton, Ontario, Canada

Contacts

Queen's University

Recruiting

Kingston, Ontario, Canada

Contacts

Queen's University

canbind.optimumd@queensu.ca

Centre for Addiction and Mental Health (CAMH)

Recruiting

Toronto, Ontario, Canada

Contacts

Centre for Addiction and Mental Health (CAMH)

416-535-8501aidan.schottler-raymond@camh.ca

University Health Network

Recruiting

Toronto, Ontario, Canada

Contacts

University Health Network

437-522-4953canbindstudies@uhn.ca

Ontario Shores Centre for Mental Health Sciences

Recruiting

Whitby, Ontario, Canada

Contacts

Ontario Shores Centre for Mental Health Sciences

905-430-4055moodstudies@ontarioshores.ca

More Information

Sponsor

Abraham Nunes

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Keywords

  • Major Depressive Disorder
  • Remission
  • Follow-up
  • Biomarkers
  • Relapse
  • Clinical predictors
  • Relapse prediction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Abraham Nunes on 2026-07-10.