Recruiting

Predictive Biomarker

Sponsor:

Nova Scotia Health Authority

Code:

NCT05017311

Conditions

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Escitalopram

Brexpiprazole

Study Details

Brief summary:

This is a study that will test a predictive biomarker algorithm based on results from a previous study. 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

Study ID

NCT05017311

Start date

Jan 20, 2023

Status verified date

Jun, 2026

Completion date

Apr 30, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Patients

Inclusion Criteria:

  • Outpatients 18 to 65 years of age.
  • Meet DSM-5 criteria for MDE in MDD as determined by SCID-5.
  • 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 (exceptions: stable use of hypnotics; stable use of stimulants for attention-deficit/hyperactive disorder).
  • MADRS score ≥ 24.
  • Fluency in English, sufficient to complete the interviews and self-report questionnaires.

Exclusion Criteria:

  • 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).

Healthy Comparison (HC) Participants

Inclusion Criteria:

  • 18 to 65 years of age.
  • No history of psychiatric disorders (as determined by SCID-5) or significant physical conditions (e.g. arthritis, fibromyalgia).
  • Fluency in English, sufficient to complete the interviews and self-report questionnaires.

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Allocation by Predictive Biomarker Algorithm; Escitalopram + Brexpiprazole

Patients are randomly assigned to the Allocation by Predictive Biomarker Algorithm group. Based on the outcome result from the personalized predictive biomarker algorithm, patients predicted as non-responders to escitalopram monotherapy will receive open-label escitalopram (10-20 mg/d) and blinded brexpiprazole (0.5-2 mg/d) for the first 8 weeks of the study. For the final 4 weeks of the study, patients will continue to receive both medications but the brexpiprazole will no longer be blinded.

placebo comparator: Allocation by Predictive Biomarker Algorithm; Placebo

Patients are randomly assigned to the Allocation by Predictive Biomarker Algorithm group. Based on the outcome result from the personalized predictive biomarker algorithm, patients predicted to respond to escitalopram monotherapy will receive open-label escitalopram (10-20 mg/d) and blinded placebo for the first 8 weeks of the study. For the final 4 weeks of the study, responders will continue to receive open-label escitalopram without the placebo and non-responders will receive a combination of open-label escitalopram and open-label brexpiprazole.

active comparator: Random Allocation; Escitalopram + Brexpiprazole

Patients are randomly assigned to the Random Allocation group and then randomly assigned to receive open-label escitalopram (10-20 mg/d) and blinded brexpiprazole (0.5-2 mg/d) for the first 8 weeks of the study. For the final 4 weeks of the study, patients will continue to receive both medications but the brexpiprazole will no longer be blinded.

placebo comparator: Random Allocation; Placebo

Patients are randomly assigned to the Random Allocation group and then randomly assigned to receive open-label escitalopram (10-20 mg/d) and blinded placebo for the first 8 weeks of the study. For the final 4 weeks of the study, responders will continue to receive open-label escitalopram without the placebo and non-responders will receive a combination of open-label escitalopram and open-label brexpiprazole.

Interventions

Escitalopram

All patients will receive open-label escitalopram (10-20 mg/d) for the entire study duration (12 weeks).

Brexpiprazole

Depending on the initial randomization process, patients will either receive blinded brexpiprazole (0.5-2 mg/d) for the entire study duration (12 weeks) or for the last 4 weeks of the study if they received the placebo during the first 8 weeks of the study and were non-responders.

Primary outcome measure

  • Change in Montgomery Asberg Depression Rating Scale (MADRS) scores from baseline [ Time Frame: Baseline to Week 8 ]

Central Contacts and Locations

Central contacts

Jessica B Toombs, MSc

9024735313Jessica.Toombs@NSHealth.ca

Nicole M Stinson, BSc

9024735313Nicole.Stinson@NSHealth.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Contacts

Maddie Kelly

403-210-7445Madison.Kelly@ucalgary.ca

Alex Du

403-220-6533mi.du@ucalgary.ca

Principal Investigator:

Valerie H Taylor, MD, PhD

University of British Columbia

Recruiting

Vancouver, British Columbia, Canada, V6T2A1

Contacts

Sara Lee

604-822-0332Sara.Lee@ubc.ca

Jennifer Tong

604-822-8012Jennifer.Tong@ubc.ca

Principal Investigator:

Raymond W Lam, MD

Nova Scotia Health Authority

Recruiting

Halifax, Nova Scotia, Canada, B3H 2E2

Contacts

Jessica Toombs, MSc

902-473-5313Jessica.Toombs@NSHealth.ca

Nicole Stinson, BSc

902-473-5313Nicole.Stinson@NSHealth.ca

Principal Investigator:

Rudolf Uher, MD, PhD

McMaster University

Recruiting

Hamilton, Ontario, Canada, L8P3B6

Contacts

Elizabeth Hewitson

905-522-1155ehewitso@stjoes.ca

Saba Khoshroo

905-522-1155skhoshro@stjoes.ca

Principal Investigator:

Benicio N Frey, MD, PhD

Queen's University

Recruiting

Kingston, Ontario, Canada, K7L4X3

Contacts

Caroline Côté

613-544-4900c.cote@queensu.ca

Rida Khan

613-544-4900khanr@providencecare.ca

Principal Investigator:

Roumen Milev, MD, PhD

The Royal Ottawa Mental Health Centre

Recruiting

Ottawa, Ontario, Canada, K1Z 7K4

Contacts

Dikshpreet Kaur

613-722-6521Dikshpreet.Kaur@theroyal.ca

Yamini Singh

613-722-6521Yamini.Singh@theroyal.ca

Principal Investigator:

Pierre Blier, MD, PhD

University Health Network

Recruiting

Toronto, Ontario, Canada, M5T2S8

Contacts

Yudi Kang

416-603-5800Yudi.Kang@uhn.ca

Franca Placenza, PhD

416-603-5800Franca.Placenza@uhn.ca

Principal Investigator:

Joshua Rosenblat, MD, MSc

Centre for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada, M6J1H4

Contacts

Victoria Herbert

416-535-8501Victoria.Herbert@camh.ca

Dima Alkaed

416-535-8501Dima.Alkaed@camh.ca

Principal Investigator:

Stefan J Kloiber, MD, PhD

Ontario Shores Centre for Mental Health Sciences

Recruiting

Whitby, Ontario, Canada, L1N 0H7

Contacts

Houra Parsinejad

905-430-4055parsinejadh@ontarioshores.ca

Emily Vernum

905-430-4055vernume@ontarioshores.ca

Principal Investigator:

Daniel Müeller, MD, PhD

University of Saskatchewan

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 0W8

Contacts

Quentin Greba

306-371-7987qmg131@usask.ca

Principal Investigator:

AG (Adekunle Garba) Ahmed, MBBS, MSc

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2026-06-11.