NCT07139834 · Jeffrey Miller
Pattern Separation in Major Depressive Disorder
What this study 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 where both patients and doctors know the treatment given fashion in this study; extended release memantine is administered in a where neither patients nor doctors know which treatment is given, randomly assigned, compared against an inactive treatment manner.
View original scientific description
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.
Interventions
DRUG
SSRI (escitalopram or sertraline)
11 weeks of open-label treatment with an SSRI, of which the last 6 weeks are augmented with memantine vs placebo. Primary SSRI for the study is escitalopram. In cases of prior intolerance or non-response to escitalopram, individuals will be treated with sertraline instead of escitalopram.
DRUG
Extended-Release Memantine
6 weeks of treatment with extended-release memantine as augmentation to ongoing escitalopram treatment
DRUG
Placebo
6 weeks of treatment with placebo as augmentation to ongoing escitalopram treatment
Primary outcome measures
Pattern Separation Performance
Time frame: At baseline (week 0) and after completing the medication trial (week 11)
Participants will complete a pattern separation task
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 14, 2026 · Source of record for eligibility and locations