Escitalopram + Memantine for Depression

Overseen By Gabriella F Restifo-Bernstein, BA

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Jeffrey Miller

Must be taking: SSRIs

Must not be taking: Antidepressants, Antipsychotics, Benzodiazepines, others

Disqualifiers: Pregnancy, Unstable illness, Bipolar, others

Compensation: Varies

Number of Visits: 2

Duration: 11 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a common depression medication, escitalopram, when combined with either extended-release memantine (a drug often used for memory issues) or a placebo (a pill with no active ingredients). Researchers aim to assess how these combinations impact brain activity, thinking skills, and depression symptoms in individuals with Major Depressive Disorder. Participants must have a depression diagnosis and not be taking any other antidepressants currently. This trial may suit those who feel persistently down and are not on other depression treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people.

Do I have to stop taking my current medications to join the trial?

Yes, you must stop taking any current antidepressant medications to join this trial. Additionally, you cannot be on certain other medications like antipsychotics, benzodiazepines, or MAOIs.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that taking escitalopram with memantine is generally safe for people with depression. Studies have found that most patients handle this combination well. For instance, one study found it to be as safe as taking escitalopram with a placebo. Another study reported that most patients did not experience serious side effects with this treatment. Overall, these findings suggest the treatment is safe for people, although individual experiences may differ. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining escitalopram with memantine for depression because this duo targets two different brain systems. Most traditional treatments for depression, like SSRIs including escitalopram, focus on serotonin levels. However, memantine works by modulating glutamate, another key neurotransmitter thought to be involved in depression. By addressing both serotonin and glutamate pathways, this combination has the potential to offer a more comprehensive approach to treating depression, potentially benefiting those who don't fully respond to standard treatments.

What evidence suggests that this trial's treatments could be effective for depression?

Research has shown that combining memantine with escitalopram can improve outcomes for people with major depressive disorder. In this trial, one group of participants will receive escitalopram and memantine, while another group will receive escitalopram with a placebo. One study found that this combination improved thinking skills more than escitalopram alone over a year. Another study demonstrated that the combination was safe and effectively reduced depression symptoms. Older adults with depression also showed improved thinking skills with this treatment. While escitalopram is a common treatment for depression, adding memantine may enhance cognitive abilities and improve overall results. ^{1 2 5 6 7}

Who Is on the Research Team?

Jeffrey M Miller, MD

Principal Investigator

New York State Psychiatric Institute (NYSPI)

Are You a Good Fit for This Trial?

This trial is for individuals with Major Depressive Disorder. Participants will be given escitalopram, a common depression treatment, and either extended-release memantine or a placebo without knowing which one they receive.

Inclusion Criteria

I have been diagnosed with major depression without psychosis recently.

I understand and can agree to the study's procedures and risks.

Proficient in English

Exclusion Criteria

Current active suicidal ideation

Current substance use disorder other than tobacco use disorder

I have been diagnosed with bipolar disorder, psychotic disorder, or dementia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo baseline medical and psychiatric assessment and fMRI scanning

1 week

1 visit (in-person)

Treatment

Participants receive escitalopram combined with either placebo or memantine in a double-blind, placebo-controlled, randomized manner

11 weeks

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Escitalopram
• Extended-Release Memantine

Trial Overview The study tests how an SSRI (escitalopram) combined with either extended-release memantine or a placebo affects brain function, activity measured by MRI scans, and symptoms of depression in participants.

How Is the Trial Designed?

Group I: SSRI + Memantine Experimental Treatment 2 Interventions

Group II: SSRI + Placebo Placebo Group 2 Interventions

Who Is Running the Clinical Trial?

Jeffrey Miller

Lead Sponsor

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31519517/

A Randomized Double-Blind Placebo-Controlled Trial of ... The combination of memantine with escitalopram was well tolerated and as effective as escitalopram and placebo in improving depression using HAM-D.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1064748119304749

A Randomized Double-Blind Placebo-Controlled Trial of ... Combination memantine and escitalopram was significantly more effective than escitalopram and placebo in improving cognitive outcomes at 12 months.

3. psychiatryadvisor.com psychiatryadvisor.com/news/escitalopram-memantine-combination-improves-cognitive-outcomes-in-older-adults-with-mdd/

Escitalopram-Memantine Combination Improves Cognitive ... The combination of memantine with escitalopram was linked to improved cognition in older patients with major depressive disorder.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00368862

Efficacy Study of Memantine Hydrochloride and ... Primary outcomes were MADRS (depression), HAM-A (anxiety), CERAD (cognitive test) and alcohol consumption (time line follow backup). Secondary Outcome Measures ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6997044/

A randomized double-blind placebo-controlled trial of ... Combination memantine and escitalopram was significantly more effective than escitalopram and placebo in improving cognitive outcomes at 12 months.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7368564/

Combined treatment with escitalopram and memantine ... Although significant group differences in mood improvement were not observed, ESC/MEM resulted in increased GMV and cortical thickness in several brain regions ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/gps.4375

Combined treatment with memantine/es‐citalopram for ... Clinical global impression: Combined escitalopram/memantine treatment was associated with highly significant improvements in CGI-depression ...