Brain Aging and Treatment Response in Geriatric Depression

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2019-01-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The proposed project will evaluate the role of neuroimaging biomarkers of brain aging (i.e., neurodegenerative and vascular brain changes) and mild cognitive impairment in the patterns of treatment response to memantine combined with escitalopram compared to escitalopram and placebo.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Memantine Plus Es-citalopram in Elderly Depressed Patients With Cognitive Impairment

NCT01876823

Mild Cognitive Impairment Major Depressive Disorder Alzheimer's Disease

COMPLETED PHASE2/PHASE3

Pattern Separation in Major Depressive Disorder

NCT07139834

Major Depressive Disorder (MDD)

NOT_YET_RECRUITING PHASE1

Clinical Trial of Memantine for Major Depression

NCT00040261

Depression

COMPLETED PHASE3

Neural Mechanisms of Monoaminergic Engagement in Late-life Depression Treatment Response (NEMO)

NCT03128021

Major Depressive Disorder

COMPLETED PHASE4

Mechanisms of Antidepressant Non-Response in Late-Life Depression

NCT01931202

Major Depressive Disorder

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study is designed to conduct a double-blind placebo-controlled trial of Namenda (Memantine) as an augmentation to Lexapro (Escitalopram) in depressed older adults 60 years of age and older. Throughout the course of the study, the investigators anticipate screening about 400 subjects to recruit 134 participants in the first four years. This study will require that the subjects complete up to 20 (twenty) visits in 12 (twelve) months to the study site during their participation. The purpose of this study is to determine whether Namenda (memantine) when taken in combination with Lexapro (escitalopram), may improve the quality of treatment response by making it faster and more complete, and also by improving thinking and memory in comparison to Lexapro taken with a placebo. Enrolled subjects will be provided with 10-20 mg of escitalopram for 12 months, and concurrently randomly assigned to either memantine or placebo groups. The investigators will also examine the safety and tolerability (how well the treatment works and the side effects) of a combination of Namenda and Lexapro as compared to placebo and Lexapro in subjects with major depressive disorder and mild cognitive impairment who are at least 60 years of age. Memantine is likely to accelerate and enhance antidepressant response to escitalopram and improve cognitive performance. Subjects with amnestic mild cognitive impairment or biomarkers of brain aging at baseline are likely to have preferential response to the combination of memantine and escitalopram compared to escitalopram and placebo, thus identifying a more personalized treatment approach in the high-risk subgroups for poor clinical outcomes.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mild Cognitive Impairment (MCI) Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Escitalopram and Memantine

Participants will take a combination of Escitalopram and Memantine for 12 months

Group Type ACTIVE_COMPARATOR

Escitalopram

Intervention Type DRUG

All subjects will receive 10 to 20mg of escitalopram open-label throughout the trial. Participants will begin taking one 10mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of escitalopram until treatment completion.

Memantine

Intervention Type DRUG

Memantine dosage will be 5 to 20mg a day. Participants will initially take one 5mg capsule once a day, which will be gradually increased to a maximum of 10mg capsules twice per day.

Escitalopram and placebo

Participants will take a combination of Escitalopram and placebo for 12 months

Group Type ACTIVE_COMPARATOR

Escitalopram

Intervention Type DRUG

All subjects will receive 10 to 20mg of escitalopram open-label throughout the trial. Participants will begin taking one 10mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of escitalopram until treatment completion.

Placebo

Intervention Type DRUG

Placebo pills will be taken in combination with the active Namenda (Memantine) pills. Participants will initially take 1 capsule per day, which will be increased to a maximum of 1 capsule twice per day.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Escitalopram

All subjects will receive 10 to 20mg of escitalopram open-label throughout the trial. Participants will begin taking one 10mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of escitalopram until treatment completion.

Intervention Type DRUG

Memantine

Memantine dosage will be 5 to 20mg a day. Participants will initially take one 5mg capsule once a day, which will be gradually increased to a maximum of 10mg capsules twice per day.

Intervention Type DRUG

Placebo

Placebo pills will be taken in combination with the active Namenda (Memantine) pills. Participants will initially take 1 capsule per day, which will be increased to a maximum of 1 capsule twice per day.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lexapro Namenda inactive substance

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for major depressive disorder (recurrent and nonrecurrent course will be identified)
* Score of 16 or higher on the 24-item Hamilton Rating Scale for Depression (HDRS) at study entry
* Score of 24 or higher on the Mini-Mental State Exam (MMSE)
* Age 60 years old or older

Exclusion Criteria

* History of psychiatric illness or a substance abuse disorder other than unipolar depression, diagnosed prior to the onset of the first depressive episode
* Presence of psychotic symptoms
* Severe or acute medical illness (e.g., major surgery, metastatic cancer, stroke, heart attack) 6 months prior to study entry
* Acute suicidal or violent behavior or history of suicide attempt within the year prior to study entry
* Presence of delirium, neurodegenerative dementia, Parkinson's disease, or any other central nervous system (CNS) diseases
* Toxic or metabolic abnormalities on laboratory examination
* Medications taken or medical illnesses present that could account for depression
* Active heart failure categorized as Class III or greater according to New York Heart Association criteria
* Heart attack or crescendo angina within the 3 months prior to study entry
* Symptomatic cardiac arrhythmias or symptomatic, hemodynamically significant mitral or aortic valvular disease
* Resting heart rate less than 50 beats per minute and a corrected QT (QTc) interval greater than 0.45 seconds
* Second or third degree atrioventricular block
* Systolic blood pressure greater than 180 mmHg or less than 90 mmHg and diastolic blood pressure greater than 105 mmHg or less than 50 mmHg at study entry
* Treated with depot neuroleptic therapy within 6 months prior to study entry
* Treated with any neuroleptic, antidepressant, anxiolytic medication (other than lorazepam), or over-the-counter CNS-active medications used for treatment of depression (e.g, St. John's Wort, kava-kava, melatonin) within 2 weeks (4 weeks for fluoxetine or monoamine-oxidase inhibitors \[MAOIs\]) prior to the first administration of study medication
* Known allergy to escitalopram or memantine or history of ineffective treatment with escitalopram or memantine for current depressive episode
* Requires concomitant therapy with any prescription or over-the-counter medications that have potentially dangerous interactions with either escitalopram or memantine
* Requires electroconvulsive therapy (ECT) or received ECT within 3 months prior to study entry
* Initiated psychotherapy within 3 months prior to study entry or will be initiating or terminating psychotherapy during the study

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No