Treatment of Geriatric Depression With Mild Cognitive Impairment: A Double-blind Placebo-Controlled Trial of Namenda (Memantine) Augmentation of Lexapro (Escitalopram) in Depressed Patients at Least 60 Years of Age
Overview
- Phase
- Phase 4
- Intervention
- Escitalopram
- Conditions
- Mild Cognitive Impairment (MCI)
- Sponsor
- University of California, Los Angeles
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- Change in Hamilton Depression Rating Scale
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Helen Lavretsky, MD
Professor
University of California, Los Angeles
Eligibility Criteria
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
Arms & Interventions
Escitalopram and Memantine
Participants will take a combination of Escitalopram and Memantine for 12 months
Intervention: Escitalopram
Escitalopram and Memantine
Participants will take a combination of Escitalopram and Memantine for 12 months
Intervention: Memantine
Escitalopram and placebo
Participants will take a combination of Escitalopram and placebo for 12 months
Intervention: Escitalopram
Escitalopram and placebo
Participants will take a combination of Escitalopram and placebo for 12 months
Intervention: Placebo
Outcomes
Primary Outcomes
Change in Hamilton Depression Rating Scale
Time Frame: Measured at 3 months; 6 months and 12 months
Clinician administered scale measures severity of depressive symptoms. This measure includes 24 items. Response options vary item to item and include the following ranges: \[0-2\], \[0-3\], and \[0-4\]. A score of 0 suggests absence of symptoms and/or difficulties and higher scores represent more severe difficulties. Possible overall score range \[0-74\], higher scores representing more severe difficulties.
Secondary Outcomes
- Change in Montgomery Asberg Depression Rating Scale(Measured at 3 months; 6 months and 12 months)
- Change in Cognitive Domain Scores(Measured at 6 months and 12 months)