Major Depressive Disorder (MDD)PERFORM-DNCT06746155
Predictors of Relapse in Major Depressive Disorder (PERFORM-D)
An observational study of Major Depressive Disorder (MDD), run by Abraham Nunes at 9 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- How many people
- 252 participants
- Where
- 9 sitesCanada
- Study dates
- 27 Dec 2024to 1 Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Canada9 sites, 9 recruiting
- Recruiting
University of Calgary
Calgary, Alberta
University of Calgary, 403-210-7445, canbind@ucalgary.ca
- Recruiting
Nova Scotia Health
Halifax, Nova Scotia
Vanessa Pardo, BA (Hons), 902-473-2697, CPSY@nshealth.ca
Abraham Nunes, MD PhD MBA FRCPC
- Recruiting
McMaster University
Hamilton, Ontario
905-522-1155 ext. 39178, skhoshro@stjosham.on.ca
- Recruiting
Queen's University
Kingston, Ontario
Queen's University, canbind.optimumd@queensu.ca
- Not yet recruiting
The Royal Ottawa Mental Health Centre
Ottawa, Ontario, K1Z 7K4
The Royal Ottawa Mental Health Centre, 613-722-6521 ext. 6856, dikskaur@theroyal.ca
613-722-6521 ext. 6405, yasingh@theroyal.ca
- Recruiting
Centre for Addiction and Mental Health (CAMH)
Toronto, Ontario
Centre for Addiction and Mental Health (CAMH), 416-535-8501 ext. 39574, aidan.schottler-raymond@camh.ca
- Recruiting
University Health Network
Toronto, Ontario
University Health Network, 437-522-4953, canbindstudies@uhn.ca
- Recruiting
University of British Columbia
Vancouver, British Columbia
University of British Columbia, 604-822-7804, Lam.MDDResearch2@ubc.ca
- Recruiting
Ontario Shores Centre for Mental Health Sciences
Whitby, Ontario
Ontario Shores Centre for Mental Health Sciences, 905-430-4055 ext. 6081, moodstudies@ontarioshores.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- Major Depressive Disorder, Remission, Follow-up, Biomarkers, Relapse, Clinical predictors, Relapse prediction
- Medical subject headings
- Depressive Disorder, Major, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start27 Dec 2024
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abraham Nunes
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University, University of British Columbia, University of Calgary, Ontario Shores Centre for Mental Health Sciences, Queen's University, Nova Scotia Health Authority, University Health Network, Toronto, Centre for Addiction and Mental Health
- Responsible party
- Sponsor-investigator, Abraham Nunes, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746155
- Sponsor's protocol ID
- CAN-BIND-20
- Acronym
- PERFORM-D
- Status last verified
- Jul 2026
- First submitted
- 30 Oct 2024
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Early Relapse During Follow-up Of Remitted Major Depression
- ClinicalTrials.gov ID
- NCT06746155
- Acronym / sponsor ID
- PERFORM-D / CAN-BIND-20
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- Major Depressive Disorder, Remission, Follow-up, Biomarkers, Relapse, Clinical predictors, Relapse prediction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Abraham NunesUniversity, hospital or other
- Collaborators
- McMaster University, University of British Columbia, University of Calgary, Ontario Shores Centre for Mental Health Sciences, Queen's University, Nova Scotia Health Authority, University Health Network, Toronto, Centre for Addiction and Mental Health
- Study start
- 27 Dec 2024 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time-to-relapse
Time frame: 18 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder (MDD), run by Abraham Nunes at 9 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanessa Pardo, BA (Hons) (902-473-2697, CPSY@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-to-relapse (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.