Pattern Separation in Major Depressive Disorder
Recruiting · NCT07139834 · Interventional (participants receive a specific treatment) · Lead sponsor: Jeffrey Miller
View the official record on ClinicalTrials.gov →Interventions studied
Extended-Release MemantinePlaceboSSRI (escitalopram or sertraline)
What this trial is about
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.
Who can take part
Age range
18 Years to 50 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion 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
Exclusion criteria
- 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, migraines, pain disorders, and other conditions not exclusionary)
- 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 (amantadine, ketamine, dextromethorphan)
- 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 component of the product
- 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
Where it is running
1 location listed across 1 US state.
- New York State Psychiatric Institute (NYSPI) - New York, New York, United States