Wellness Monitoring for Major Depressive Disorder

Major Depressive Disorder Clinical Trial

— CBN-Well  

Official title:

A Collaborative Investigation of Predictors of Relapse in Major Depressive Disorder: CAN-BIND-1 Extension Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02934334
• Other study ID #: REB 15-9780-AE
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

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.

External Links

•   CAN-BIND study website
•   Press release