Major Depressive DisorderCBN-WellNCT02934334
Wellness Monitoring for Major Depressive Disorder
An observational study of Major Depressive Disorder, run by Sidney Kennedy at 5 sites in Canada.
Trial summary
The Wellness Monitoring for Major Depressive Disorder (MDD) study is a prospective, longitudinal, observational study aimed at identifying biomarkers of relapse in MDD. Results may help refine clinical approach to relapse management, and may ultimately help MDD patients sustain wellness while on antidepressant… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Observational
- How many people
- 100 participants
- Where
- 5 sitesCanada
- Study dates
- 31 May 2016to 25 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and women between 18 to 65 years of age who have previously met DSM-V criteria for Major Depressive Episode (MDE) in MDD as determined by MINI, (1) who participated in CAN-BIND-1 protocol, (2) other CAN-BIND studies, and (3) other remitters who meet the inclusion criteria who are currently responding to antidepressant medication or a combination of treatments.
Who may be able to join
- Meet DSM-V criteria for Major Depressive Episode (MDE) in MDD as determined by MINI.
- MADRS total score of equal to or less than 14.
- In the current MDE, patient must currently be responding to an antidepressant medication or a combination of treatments for MDD.
- Willing and able to complete self-reported assessments via a study-specific smartphone (LogPad), including sufficient fluency in English.
- Willing to wear GT9X Link, a wrist-worn device for the duration of the study.
Who cannot join
- Axis I diagnosis, other than MDD, that is considered the primary diagnosis.
- Bipolar I or Bipolar II diagnosis (lifetime), MDD with psychotic features (lifetime), schizophrenia, or schizoaffective disorder.
- Presence of a significant Axis II diagnosis (borderline, antisocial).
- High suicidal risk, defined by clinician judgement.
- History of drug or alcohol use, with severity of at least moderate or severe, according to DSM criteria, within 6 months before screening.
- Presence of significant neurological disorders, head trauma, or other unstable medical conditions.
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- Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before screening or is currently enrolled in an investigational study.
- Has a condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g. compromise well being) or that could prevent, limit, or confound the protocol-specified assessments.
- Subject is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, or is a family member of an employee or the investigator.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
University of Calgary
Calgary, Alberta, T2N 4Z6
McMaster University
Hamilton, Ontario, L8N 3K7
Queen's University
Kingston, Ontario, K7L 4X3
University Health Network
Toronto, Ontario, M5T 2S8
University of British Columbia
Vancouver, British Columbia, V6T 1Z3
About this study
Official title: A Collaborative Investigation of Predictors of Relapse in Major Depressive Disorder: CAN-BIND-1 Extension Study
The Wellness Monitoring for Major Depressive Disorder (MDD) study is a prospective, longitudinal, observational study aimed at identifying biomarkers of relapse in MDD. Results may help refine clinical approach to relapse management, and may ultimately help MDD patients sustain wellness while on antidepressant medication.
Read the detailed description
This study involves a naturalistic follow up of responders from the study entitled "Integrated biological markers for the prediction of treatment response in depression", or the CAN-BIND-1 study. In addition, this study is also open to other participants who completed other CAN-BIND studies, as well as remitters who meet the inclusion criteria. Since patients usually seek medical attention only after relapse has occurred, imminent precursors to relapse are not well known. In this study, participants who are currently responding to an oral antidepressant treatment regimen and/or therapeutic intervention will be monitored over a minimum period of 13 months, which provides a unique opportunity to discover near-term biomarkers of relapse.
The study is conducted in partnership with Janssen Research \& Development and utilizes remote monitoring technology for data gathering.
- Conditions
- Major Depressive Disorder
- Being tested
- Observational
- Keywords
- major depression, major depressive episode, biomarkers, relapse, near term relapse, m-health
- Medical subject headings
- Depressive Disorder, Major, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
| Study group | Role | What they receive |
|---|---|---|
| MDD | Major Depressive Disorder Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of MDD Patients with Near Term Relapse
Relapse is defined as:
- MADRS total score equal to or greater than 22 on at least 2 consecutive visits (scheduled or unscheduled);
- Hospitalization for worsening of depression;
- Suicidal ideation with intent, or suicidal behaviour;
- Others. Investigators will be asked to describe.
Measured: Baseline up to the one year enrolment period for the last-subject-in.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study start31 May 2016
- Primary completion14 Jan 2019
- Study completion25 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kennedy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sidney Kennedy, University Health Network, Toronto
- Investigators
- Sidney H. Kennedy, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934334
- Sponsor's protocol ID
- REB 15-9780-AE
- Acronym
- CBN-Well
- Status last verified
- Nov 2020
- First submitted
- 12 Oct 2016
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: This study is funded in part by the Ontario Brain Institute (OBI). Data collected from this study is entered into a research database called "Brain-CODE", deployed at a High Performance Computer Virtual Lab (HPCVL). The HPCVL supports the regulatory-compliant (e.g., 21 CRF Part 11, HIPAA, PIPEDA) processes for securing privacy of healthcare data.
Publications
Kennedy SH, Downar J, Evans KR, Feilotter H, Lam RW, MacQueen GM, Milev R, Parikh SV, Rotzinger S, Soares C. The Canadian Biomarker Integration Network in Depression (CAN-BIND): advances in response prediction. Curr Pharm Des. 2012;18(36):5976-89. doi: 10.2174/138161212803523635.
PubMed 22681173Lam RW, Milev R, Rotzinger S, Andreazza AC, Blier P, Brenner C, Daskalakis ZJ, Dharsee M, Downar J, Evans KR, Farzan F, Foster JA, Frey BN, Geraci J, Giacobbe P, Feilotter HE, Hall GB, Harkness KL, Hassel S, Ismail Z, Leri F, Liotti M, MacQueen GM, McAndrews MP, Minuzzi L, Muller DJ, Parikh SV, Placenza FM, Quilty LC, Ravindran AV, Salomons TV, Soares CN, Strother SC, Turecki G, Vaccarino AL, Vila-Rodriguez F, Kennedy SH; CAN-BIND Investigator Team. Discovering biomarkers for antidepressant response: protocol from the Canadian biomarker integration network in depression (CAN-BIND) and clinical characteristics of the first patient cohort. BMC Psychiatry. 2016 Apr 16;16:105. doi: 10.1186/s12888-016-0785-x.
PubMed 27084692Vaccarino AL, Evans KR, Kalali AH, Kennedy SH, Engelhardt N, Frey BN, Greist JH, Kobak KA, Lam RW, MacQueen G, Milev R, Placenza FM, Ravindran AV, Sheehan DV, Sills T, Williams JB. The Depression Inventory Development Workgroup: A Collaborative, Empirically Driven Initiative to Develop a New Assessment Tool for Major Depressive Disorder. Innov Clin Neurosci. 2016 Oct 1;13(9-10):20-31. eCollection 2016 Sep-Oct.
PubMed 27974997
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Collaborative Investigation of Predictors of Relapse in Major Depressive Disorder: CAN-BIND-1 Extension Study
- ClinicalTrials.gov ID
- NCT02934334
- Acronym / sponsor ID
- CBN-Well / REB 15-9780-AE
- Conditions
- Major Depressive Disorder
- Keywords
- major depression, major depressive episode, biomarkers, relapse, near term relapse, m-health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sidney KennedyUniversity, hospital or other
- Study start
- 31 May 2016 (actual)
- Primary completion
- 14 Jan 2019 (actual)
- Study completion
- 25 Feb 2019 (actual)
- First posted
- 14 Oct 2016 (estimated)
- 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.
The Wellness Monitoring for Major Depressive Disorder (MDD) study is a prospective, longitudinal, observational study aimed at identifying biomarkers of relapse in MDD. Results may help refine clinical approach to relapse management, and may ultimately help MDD patients sustain wellness while on antidepressant medication.
Detailed description
This study involves a naturalistic follow up of responders from the study entitled "Integrated biological markers for the prediction of treatment response in depression", or the CAN-BIND-1 study. In addition, this study is also open to other participants who completed other CAN-BIND studies, as well as remitters who meet the inclusion criteria. Since patients usually seek medical attention only after relapse has occurred, imminent precursors to relapse are not well known. In this study, participants who are currently responding to an oral antidepressant treatment regimen and/or therapeutic intervention will be monitored over a minimum period of 13 months, which provides a unique opportunity to discover near-term biomarkers of relapse.
The study is conducted in partnership with Janssen Research \& Development and utilizes remote monitoring technology for data gathering.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDD | – | Other: ObservationalMajor Depressive Disorder |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women between 18 to 65 years of age who have previously met DSM-V criteria for Major Depressive Episode (MDE) in MDD as determined by MINI, (1) who participated in CAN-BIND-1 protocol, (2) other CAN-BIND studies, and (3) other remitters who meet the inclusion criteria who are currently responding to antidepressant medication or a combination of treatments.
Key inclusion criteria (5 listed)
- Meet DSM-V criteria for Major Depressive Episode (MDE) in MDD as determined by MINI.
- MADRS total score of equal to or less than 14.
- In the current MDE, patient must currently be responding to an antidepressant medication or a combination of treatments for MDD.
- Willing and able to complete self-reported assessments via a study-specific smartphone (LogPad), including sufficient fluency in English.
- Willing to wear GT9X Link, a wrist-worn device for the duration of the study.
Key exclusion criteria (9 listed)
- Axis I diagnosis, other than MDD, that is considered the primary diagnosis.
- Bipolar I or Bipolar II diagnosis (lifetime), MDD with psychotic features (lifetime), schizophrenia, or schizoaffective disorder.
- Presence of a significant Axis II diagnosis (borderline, antisocial).
- High suicidal risk, defined by clinician judgement.
- History of drug or alcohol use, with severity of at least moderate or severe, according to DSM criteria, within 6 months before screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational | Other | MDD |
Primary outcome
Rate of MDD Patients with Near Term Relapse
Time frame: Baseline up to the one year enrolment period for the last-subject-in.
Relapse is defined as: 1. MADRS total score equal to or greater than 22 on at least 2 consecutive visits (scheduled or unscheduled); 2. Hospitalization for worsening of depression; 3. Suicidal ideation with intent, or suicidal behaviour; 4. Others. Investigators will be asked to describe.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Background: PubMed 22681173Kennedy SH, Downar J, Evans KR, Feilotter H, Lam RW, MacQueen GM, Milev R, Parikh SV, Rotzinger S, Soares C. The Canadian Biomarker Integration Network in Depression (CAN-BIND): advances in response prediction. Curr Pharm Des. 2012;18(36):5976-89. doi: 10.2174/138161212803523635.
- Background: PubMed 27084692Lam RW, Milev R, Rotzinger S, Andreazza AC, Blier P, Brenner C, Daskalakis ZJ, Dharsee M, Downar J, Evans KR, Farzan F, Foster JA, Frey BN, Geraci J, Giacobbe P, Feilotter HE, Hall GB, Harkness KL, Hassel S, Ismail Z, Leri F, Liotti M, MacQueen GM, McAndrews MP, Minuzzi L, Muller DJ, Parikh SV, Placenza FM, Quilty LC, Ravindran AV, Salomons TV, Soares CN, Strother SC, Turecki G, Vaccarino AL, Vila-Rodriguez F, Kennedy SH; CAN-BIND Investigator Team. Discovering biomarkers for antidepressant response: protocol from the Canadian biomarker integration network in depression (CAN-BIND) and clinical characteristics of the first patient cohort. BMC Psychiatry. 2016 Apr 16;16:105. doi: 10.1186/s12888-016-0785-x.
- Background: PubMed 27974997Vaccarino AL, Evans KR, Kalali AH, Kennedy SH, Engelhardt N, Frey BN, Greist JH, Kobak KA, Lam RW, MacQueen G, Milev R, Placenza FM, Ravindran AV, Sheehan DV, Sills T, Williams JB. The Depression Inventory Development Workgroup: A Collaborative, Empirically Driven Initiative to Develop a New Assessment Tool for Major Depressive Disorder. Innov Clin Neurosci. 2016 Oct 1;13(9-10):20-31. eCollection 2016 Sep-Oct.
- Press releaseLink provided by the sponsor.
- CAN-BIND study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. This study is funded in part by the Ontario Brain Institute (OBI). Data collected from this study is entered into a research database called "Brain-CODE", deployed at a High Performance Computer Virtual Lab (HPCVL). The HPCVL supports the regulatory-compliant (e.g., 21 CRF Part 11, HIPAA, PIPEDA) processes for securing privacy of healthcare data.
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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. This study is not recruiting at the moment.
Sidney H. Kennedy, MD principal investigator
University Health Network, Toronto
5 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, run by Sidney Kennedy at 5 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of MDD Patients with Near Term Relapse (time frame: Baseline up to the one year enrolment period for the last-subject-in.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02934334, which also lists 3 linked publications.
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 4 Nov 2020.