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Brain Aging and Treatment Response in Geriatric Depression

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ClinicalTrials.gov Identifier: NCT01902004
Recruitment Status : Active, not recruiting
First Posted : July 17, 2013
Last Update Posted : December 5, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Helen Lavretsky, MD, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
MCI Depression Drug: Escitalopram Drug: Memantine Drug: Placebo Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 2013
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : July 2019


Arm Intervention/treatment
Active Comparator: Escitalopram and Memantine
Participants will take a combination of Escitalopram and Memantine for 12 months
Drug: 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.
Other Name: Lexapro

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.
Other Name: Namenda

Active Comparator: Escitalopram and placebo
Participants will take a combination of Escitalopram and placebo for 12 months
Drug: 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.
Other Name: Lexapro

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.
Other Name: inactive substance




Primary Outcome Measures :
  1. 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

  2. Change in Montgomery Asberg Depression Rating Scale [ Time Frame: Measured at 3 months; 6 months and 12 months ]
    Clinician administered scale measures severity of depressive symptoms


Secondary Outcome Measures :
  1. Change in cognitive domain scores [ Time Frame: Measured at 6 months and 12 months ]
    Neuropsychological battery of tests


Other Outcome Measures:
  1. Number of Participants with Adverse Events [ Time Frame: Measured at 3, 6 months and 12 months ]
    UKU Side Effect Rating Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902004


Locations
United States, California
UCLA Semel Institute - Neuropsychiatric Institute (NPI)
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Helen Lavretsky, M.D. University of California, Los Angeles

Responsible Party: Helen Lavretsky, MD, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01902004     History of Changes
Other Study ID Numbers: R-01 MH097892
R01MH097892 ( U.S. NIH Grant/Contract )
First Posted: July 17, 2013    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Helen Lavretsky, MD, University of California, Los Angeles:
Major Depression
Geriatric Major Depression
Executive Cognitive Dysfunction
Mild Cognitive Impairment
Older Adults
Geriatric
Executive Cognitive Impairment
Quality of Life
Disability
Comorbidity
Medical Burden
Safety
Candidate Genes

Additional relevant MeSH terms:
Depression
Depressive Disorder
Cognitive Dysfunction
Behavioral Symptoms
Mood Disorders
Mental Disorders
Cognition Disorders
Neurocognitive Disorders
Citalopram
Dexetimide
Memantine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Dopamine Agents