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

Prior 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

Other illness

• Presence of significant neurological disorders, head trauma, or other unstable medical conditions.
• Failure of 4 or more adequate pharmacologic interventions (as determined by the Antidepressant Treatment History Form).

Other

• 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.
• Pregnant or breastfeeding.
• Started psychological treatment within the past 3 months with the intent of continuing treatment.

• 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.

Criteria the registry did not label

• Patients