RecruitingPhase 4NCT05017311

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

Sponsor

Nova Scotia Health Authority

Enrollment

400 participants

Start Date

Jan 20, 2023

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria9

Patients
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.
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.

Exclusion Criteria11

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

Interventions

DRUGBrexpiprazole

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.

DRUGEscitalopram

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