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MCI | Brain Aging and Treatment Response in Geriatric Depression

MCI research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - Meets DSM 5 criteria for major depressive disorder (recurrent and nonrecurrent course will be identified) - Score of 20 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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

MCI

Depression

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:EscitalopramAll 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.

Drug:MemantineMemantine 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.

Drug:PlaceboPlacebo 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Recruiting

Start Date: October 2013

Completed Date: March 2018

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Change in Hamilton Depression Rating Scale (HDRS) scores

Secondary Outcome: Change in cognitive domain scores

Study sponsors, principal investigator, and references

Principal Investigator: Helen Lavretsky, M.D.

Lead Sponsor: University of California, Los Angeles

Collaborator: National Institute of Mental Health (NIMH)

More information:https://clinicaltrials.gov/show/NCT01902004

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