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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02934334
Other study ID # REB 15-9780-AE
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 31, 2016
Est. completion date February 25, 2019

Study information

Verified date November 2020
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 medication.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date February 25, 2019
Est. primary completion date January 14, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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. - 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.

Study Design


Intervention

Other:
Observational


Locations

Country Name City State
Canada University of Calgary Calgary Alberta
Canada McMaster University Hamilton Ontario
Canada Queen's University Kingston Ontario
Canada University Health Network Toronto Ontario
Canada University of British Columbia Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
Sidney Kennedy

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View Citation

Lam 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, Müller 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. — View Citation

Vaccarino 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Baseline up to the one year enrolment period for the last-subject-in.
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