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

Major Depressive Disorder

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).

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Conditions de participation

  • Sexe:

    ALL
  • Âges admissibles:

    18 to 65

Critères de participation

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.

Lieu de l'étude

University of Calgary
University of Calgary
Calgary, Alberta
Canada

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Queen's University
Queen's University
Kingston, Ontario
Canada

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University of British Columbia
University of British Columbia
Vancouver, British Columbia
Canada

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University Health Network
University Health Network
Toronto, Ontario
Canada

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Primary Contact

Franca M Placenza, PhD

[email protected]
416-603-5800
McMaster University
McMaster University
Hamilton, Ontario
Canada

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Nova Scotia Health Authority
Nova Scotia Health Authority
Halifax, Nova Scotia
Canada

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Backup Contact

Jill Cumby, MSc

[email protected]
9024731780
Primary Contact

Nicole Stinson, BSc

[email protected]
90240200474735313
Centre for Addiction and Mental Health
Centre for Addiction and Mental Health
Toronto, Ontario
Canada

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Primary Contact

Ilona Gorbovskaya

[email protected]
416-535-8501
Étude parrainée par
Nova Scotia Health Authority
Participants recherchés
Plus d'informations
ID de l'étude: NCT05017311