Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D)

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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.

• 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.

Locations
Other Locations
Canada
University of Calgary
NOT_YET_RECRUITING
Calgary
Nova Scotia Health Authority
RECRUITING
Halifax
McMaster University
NOT_YET_RECRUITING
Hamilton
Queen's University
NOT_YET_RECRUITING
Kingston
Centre for Addiction and Mental Health
NOT_YET_RECRUITING
Toronto
University Health Network
NOT_YET_RECRUITING
Toronto
University of British Columbia
NOT_YET_RECRUITING
Vancouver
Contact Information
Primary
Nicole Stinson, BSc
nicole.stinson@nshealth.ca
9024735313
Backup
Jill M Cumby, MSc
jill.cumby@nshealth.ca
9024731780
Time Frame
Start Date: 2023-01-20
Estimated Completion Date: 2029-04-30
Participants
Target number of participants: 400
Treatments
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.
Authors
Sidney H Kennedy
Related Therapeutic Areas
Major Depression
Sponsors
Collaborators: Dalhousie University, University of Ottawa, Queen's University, Simon Fraser University, Centre for Addiction and Mental Health, McGill University, University of Michigan, University of British Columbia, University of Calgary, Unity Health Toronto, McMaster University
Leads: Nova Scotia Health Authority

This content was sourced from clinicaltrials.gov

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