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

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborators: Baycrest; Centre for Addiction and Mental Health; Dalhousie University; McGill University; McMaster University; Queen's University; Simon Fraser University; Unity Health Toronto; University of British Columbia; University of Calgary; University of Michigan; University of Ottawa
• Treatments: Brexpiprazole; Citalopram

Criteria

Patients

Inclusion Criteria:

• 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.

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 60 years of age.

• No history of psychiatric disorders (as determined by the modified MINI v.6.0.) or significant physical conditions (e.g. arthritis, fibromyalgia).

• Fluency in English, sufficient to complete the interviews and self-report questionnaires.