Canadian Biomarker Integration Network for Depression (CAN-BIND) - Validation Study

NCT04162522 | Completed Phase 3

• 1 other identifier: 19-5371
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 6

Brief Summary

This is a validation study that will replicate a completed study designed to assess biomarkers of treatment response to standard antidepressant treatment. The goal of this study is to integrate clinical, imaging, EEG, and molecular data across 8 sites to predict treatment outcome for patients experiencing a major depressive episode (MDE).

Conditions

Major Depressive Disorder

Keywords

major depression; major depressive disorder; MDD; escitalopram; brexpiprazole; neuroimaging; genomics; proteomics; metabolomics

Outcome Measures

Primary Outcomes (1)

• Change in Montgomery Asberg Depression Rating Scale (MADRS) scores from baseline

  Measured as clinical response, defined as a decrease in Montgomery Asberg Depression Rating Scale (MADRS) score at the Week 8 and Week 16 visits, by 50% or greater, from MADRS score at Baseline visit (i.e., lower MADRS scores = better outcome)

  Week 8, Week 16

Study Arms (2)

escitalopram (10-20 mg)

ACTIVE COMPARATOR

Participants are given escitalopram for 8 weeks. At week 8, participants will be assessed and classified as "responders" or "non-responders". Responders will continue on escitalopram until the study endpoint (16 weeks).

Drug: Escitalopram

brexpiprazole (0.5-2 mg)

ACTIVE COMPARATOR

At week 8, participants classified as "non-responders" will be given 8 weeks of brexpiprazole as add-on treatment to escitalopram.

Drug: Brexpiprazole

Interventions

Escitalopram DRUG

Participants are given escitalopram for 8 weeks. At week 8, those classified as responders will continue on escitalopram until the end of study.

Also known as: Cipralex

escitalopram (10-20 mg)

Brexpiprazole DRUG

Participants who are classified as non-responders are given 8 weeks add-on brexpiprazole, in addition to escitalopram, for the remainder of the study.

Also known as: Rexulti

brexpiprazole (0.5-2 mg)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Outpatients 18 to 60 years of age.
• Meet DSM-5 criteria for MDE in MDD as determined by the MINI.
• Episode duration \> 3 months.
• Free of psychotropic medications for at least 5 half-lives (e.g. 1 week for most antidepressants, 5 weeks for fluoxetine) before baseline Visit 1.
• MADRS score ≥ 24.
• Fluency in English, sufficient to complete the interviews and self-report questionnaires.

You may not qualify if:

• Any diagnosis, other than MDD, that is considered the primary diagnosis.
• Bipolar I or Bipolar-II diagnosis.
• Presence of a significant Axis II diagnosis (borderline, antisocial).
• High suicidal risk, defined by clinician judgment.
• Substance dependence/abuse in the past 6 months.
• Presence of significant neurological disorders, head trauma, or other unstable medical conditions.
• Pregnant or breastfeeding.
• Failure of 4 or more adequate pharmacologic interventions (as determined by the Antidepressant Treatment History Form).
• Started psychological treatment within the past 3 months with the intent of continuing treatment.
• Patients who have previously failed escitalopram or showed intolerance to escitalopram or brexpiprazole, and patients at risk for hypomanic switch (i.e. with a history of antidepressant induced hypomania).

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Unity Health Toronto: collaborator
• Baycrest: collaborator
• Centre for Addiction and Mental Health: collaborator
• McMaster University: collaborator
• Queen's University: collaborator
• University of Ottawa: collaborator
• University of British Columbia: collaborator
• University of Calgary: collaborator
• McGill University: collaborator
• Dalhousie University: collaborator
• University of Michigan: collaborator
• Simon Fraser University: collaborator

Study Sites (6)

University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

University of British Columbia

Vancouver, British Columbia, V6T2A1, Canada

Location

McMaster University

Hamilton, Ontario, L8P3B6, Canada

Location

Queen's University

Kingston, Ontario, K7L4X3, Canada

Location

University Health Network

Toronto, Ontario, M5T2S8, Canada

Location

Centre for Addiction and Mental Health

Toronto, Ontario, M6J1H4, Canada

Location

Related Publications (3)

• 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

• Kennedy SH, Lam RW, Rotzinger S, Milev RV, Blier P, Downar J, Evans KR, Farzan F, Foster JA, Frey BN, Giacobbe P, Hall GB, Harkness KL, Hassel S, Ismail Z, Leri F, McInerney S, MacQueen GM, Minuzzi L, Muller DJ, Parikh SV, Placenza FM, Quilty LC, Ravindran AV, Sassi RB, Soares CN, Strother SC, Turecki G, Vaccarino AL, Vila-Rodriguez F, Yu J, Uher R; CAN-BIND Investigator Team. Symptomatic and Functional Outcomes and Early Prediction of Response to Escitalopram Monotherapy and Sequential Adjunctive Aripiprazole Therapy in Patients With Major Depressive Disorder: A CAN-BIND-1 Report. J Clin Psychiatry. 2019 Feb 5;80(2):18m12202. doi: 10.4088/JCP.18m12202.

  PMID: 30840787 BACKGROUND

• 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

Related Links

• CAN-BIND study website
• Maclean's news article on suicide prediction and CAN-BIND research

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Escitalopram; Dexetimide; brexpiprazole

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Sidney H Kennedy, MD

  University Health Network, St. Michael's University, University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry, University of Toronto, Arthur Sommer Rotenberg Chair in Suicide & Depression Studies, St. Michael's Hospital, Principal Investigator, Canadian Biomarker Integration Network for Depression, University Health Network

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 14, 2019
• Study Start: December 23, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

CA (6)