Wellness Monitoring for Major Depressive Disorder

NCT02934334 | Completed DMC

• 1 other identifier: REB 15-9780-AE
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Major Depressive Disorder

Keywords

major depression; major depressive episode; biomarkers; relapse; near term relapse; m-health

Outcome Measures

Primary Outcomes (1)

• Rate of MDD Patients with Near Term Relapse

  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.

  Baseline up to the one year enrolment period for the last-subject-in.

Study Arms (1)

MDD

Major Depressive Disorder

Other: Observational

Interventions

Observational OTHER

MDD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kennedy: lead

Study Sites (5)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

Location

McMaster University

Hamilton, Ontario, L8N 3K7, Canada

Location

Queen's University

Kingston, Ontario, K7L 4X3, Canada

Location

University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

Related 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. doi: 10.2174/138161212803523635.

  PMID: 22681173 BACKGROUND

• 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, 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.

  PMID: 27084692 BACKGROUND

• 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.

  PMID: 27974997 BACKGROUND

Related Links

• Press release
• CAN-BIND study website

Biospecimen

Retention: SAMPLES WITH DNA

At each 8 week visit, blood samples for biochemical, genomic, and proteomic analysis will be collected and stored at -80'C freezer. Plasma: Venous blood will be collected in 6mL and 10ml EDTA blood tubes, followed by centrifugation in a refrigerated centrifuge to obtain the plasma. Two milliliters of plasma from each tube will be divided into 8 cryovials (500µL). DNA for methylation analysis: Venous blood will be collected in 8.5 mL PAXgene DNA tubes. DNA for studying histone modifications: Venous blood will be collected in 6mL EDTA blood tubes and the mixed contents will be divided evenly into three 2 mL screw-cap tubes. RNA for mRNA and miRNA sequencing: Venous blood will be collected in 6mL EDTA blood tubes and the mixed contents will be passed through LeukoLOCK filters according to the manufacturer's instructions.

MeSH Terms

Conditions

Depressive Disorder, Major; Recurrence

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Sidney H. Kennedy, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Scientist, Psychiatrist

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 14, 2016
• Study Start: May 31, 2016
• Primary Completion: January 14, 2019
• Study Completion: February 25, 2019
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share

Locations

CA (5)