Brain Aging and Treatment Response in Geriatric Depression

Completed · Phase 4 · Has a placebo group

Conditions studied: Mild Cognitive Impairment (MCI), Depression

In brief

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.

Key facts

Study ID

NCT01902004

Run by

University of California, Los Angeles

People needed

115

Starts

2013-10-01

Expected to finish

2019-01-23

Last updated by the study team

2019-10-15

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCLA Semel Institute - Neuropsychiatric Institute (NPI) — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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