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New treatment option for Major Depressive Disorder (MDD)
Official title Pattern Separation in Major Depressive Disorder
ClinicalTrials.gov ID: NCT07139834
What this study is testing
What is SSRI (escitalopram or sertraline)?
SSRI (escitalopram or sertraline) is an investigational medicine, being studied as a potential treatment for major depressive disorder (mdd).
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 study seeks to examine the effects of treatment with a selective serotonin reuptake inhibitor (SSRI), escitalopram, a first-line treatment for depression, in combination with placebo or with extended-release memantine, on neuropsychological function, regional brain activity assessed by functional magnetic resonance imaging, and depressive symptoms, in participants with Major Depressive Disorder. Escitalopram is administered in an open-label fashion in this study; extended release memantine is administered in a double-blind, randomized, placebo-controlled manner.
- Phase 1: an early, usually small safety study
- 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 50
You may be able to join if
- Age 18-50
- Current diagnosis of MDD without psychotic features assessed within three weeks of study enrollment
- 17-item Hamilton Depression Rating Scale score ≥17 assessed within 3 weeks of study enrollment
- Using an effective form of contraception at study enrollment and agrees to continue throughout study participation for individuals of child-bearing...
- Capacity to provide informed consent
You likely can't join if
- Currently taking an antidepressant medication at study enrollment
- Pregnant or breastfeeding at time of enrollment
- Evidence of current unstable medical illness, including liver or renal impairment, or unstable cardiovascular or respiratory illness
- QTc interval greater than 500 ms
- Current genitourinary conditions that raise urine pH such as a) renal tubular acidosis or b) severe infection of the urinary tract.
- Clinically significant neurological conditions, including a) history of stroke, b) previous head injury with evidence of cognitive impairment, c)...
See the full eligibility criteria
- Age 18-50
- Current diagnosis of MDD without psychotic features assessed within three weeks of study enrollment
- 17-item Hamilton Depression Rating Scale score ≥17 assessed within 3 weeks of study enrollment
- Using an effective form of contraception at study enrollment and agrees to continue throughout study participation for individuals of child-bearing potential
- Capacity to provide informed consent
- Proficient in English
- Willing to provide emergency contact
- Currently taking an antidepressant medication at study enrollment
- Pregnant or breastfeeding at time of enrollment
- Evidence of current unstable medical illness, including liver or renal impairment, or unstable cardiovascular or respiratory illness
- QTc interval greater than 500 ms
- Current genitourinary conditions that raise urine pH such as a) renal tubular acidosis or b) severe infection of the urinary tract.
- Clinically significant neurological conditions, including a) history of stroke, b) previous head injury with evidence of cognitive impairment, c) history of malignancy or d) history of seizure disorder. (headache...
- Lifetime diagnosis of a) bipolar disorder, b) psychotic disorder, or c) dementia
- Current active suicidal ideation
- Current substance use disorder other than tobacco use disorder
- Current or recent (past 6 months) treatment with antipsychotics; current or recent (past 1 month) treatment with benzodiazepines; current use of prescribed stimulant medication; current use of other NMDA antagonists...
- Current use of disulfiram with oral concentrate, MAOIs (including linezolid or IV methylene blue), or pimozide
- History of hypersensitivity or allergic reaction to a) memantine hydrochloride or any of its components/excipients, b) citalopram, escitalopram, or any other component of the product, or c) sertraline or any other...
- Concurrent or recent (past 6 months) participation in another clinical trial for mental illness involving an investigational product or device
- Lack of response to or intolerable side-effects from trials of two or more selective serotonin reuptake inhibitors of adequate dose and duration at study enrollment
- Electroconvulsive therapy (ECT) in the past 6 months
- Any condition or material in the body that is a contraindication for MRI procedures
- Weight that exceeds 300 lbs or inability to fit into MRI scanner
- MST LDI score greater than 0.5
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
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 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. 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.