NCT01902004.

Study name	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
Methods	Double‐blind placebo‐controlled trial of namenda (memantine) as an augmentation to lexapro (escitalopram) in depressed older adults 60 years of age and older Enrolled participants will be provided with 10‐20 mg of escitalopram for 12 months, and concurrently randomly assigned to either memantine or placebo groups Allocation: randomised Intervention model: parallel assignment Masking: double‐blind (participant, caregiver, investigator, outcomes assessor) Primary purpose: treatment
Participants	Inclusion criteria Meets DSM 5 criteria for major depressive disorder (recurrent and non recurrent course will be identified) Score of 20 or higher on the HRSD‐24 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 categorised 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, haemodynamically 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
Interventions	escitalopram + placebo/memantine
Outcomes	Primary outcome measures: Change in HRSD scores. Time frame: measured at 6 months and 12 months
Starting date	October 2013
Contact information	mailto:nstcyr%40mednet.ucla.edu?subject=NCT01902004, R‐01 MH097892, Brain Aging and Treatment Response in Geriatric Depression
Notes	NCT01902004