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New treatment option for Major Depressive Disorder
Official title Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D)
ClinicalTrials.gov ID: NCT05017311
What this study is testing
What is Escitalopram?
Escitalopram is an investigational medicine, being studied as a potential treatment for major depressive disorder.
Also referred to as Cipralex.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- MADRS score ≥ 24.
You likely can't join if
- 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.
See the full eligibility criteria
- 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...
- MADRS score ≥ 24.
- Fluency in English, sufficient to complete the interviews and self-report questionnaires.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Vancouver, British Columbia, Canada
- Halifax, Nova Scotia, Canada
- Hamilton, Ontario, Canada
- Kingston, Ontario, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- Whitby, Ontario, Canada
- Saskatoon, Saskatchewan, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Vancouver, British Columbia, Canada; Halifax, Nova Scotia, Canada; Hamilton, Ontario, Canada; Kingston, Ontario, Canada; Ottawa, Ontario, Canada and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.