Los Angeles, California 90095


Purpose:

The purpose of this study is to examine the effects of levomilnacipran (FETZIMA) compared to placebo for the treatment of depression in older adults.


Study summary:

A 12-week pilot double-blind comparison of levomilnacipran (FETZIMA) to placebo for the treatment of geriatric depression. The investigators are interested in assessing the efficacy of levomilnacipran (LMIL) to placebo (PBO), and exploring the effects of antidepressant response on brain connectivity and neuroplasticity. This pilot study is designed to determine any differences in the efficacy, safety and tolerability of levomilnacipran compared to placebo, and to perform dose finding (20-120 mg per day) in 60 older depressed adults. The investigators anticipate that the LMIL will be superior to PBO in improving levels of depressive symptoms and rates of remission, as well as improving cognition, apathy, and quality of life. This proposal expands the investigator's focus on the biomarkers of neuroplasticity that have been used in several prior studies and demonstrated responsivity to antidepressant treatment. The purpose is to examine this directly in 60 older adults with major depression. This proposed trial will also serve as a pilot study to estimate the efficacy and tolerability of the drug in older depressed adults, and the dose-finding in this population.


Criteria:

Inclusion Criteria: - 60 years of age or older - The presence of a major depressive disorder diagnosed according to the DSM-V criteria - A 24-item Hamilton Rating Scale for Depression (HAMD) score of 17 or higher at baseline - Mini-Mental State Exam (MMSE) score > 24. Exclusion Criteria: Subjects will be excluded if they had 1) any current and/or lifetime history of other psychiatric disorders (except unipolar depression with or without comorbid generalized anxiety disorder), or 2) recent unstable medical or neurological disorders; 3) any disabilities preventing participation in the study or in the MRI; 4) diagnosis of dementia; 5) acute suicidality; 6) subjects with known allergic reactions to milnacipran, uncontrolled narrow angle glaucoma, seizures, poorly-controlled hypertension or ischemic changes on ECG, serotonin syndrome, or the recently used MAOIs within last 4 weeks; 7) ineligible for MRI (e.g., metal in the body or claustrophobia)


NCT ID:

NCT02466958


Primary Contact:

Principal Investigator
Helen Lavretsky, M.D.
University of California, Los Angeles

Helen Lavretsky, M.D.
Phone: 310-794-4619
Email: hlavrets@ucla.edu


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States

Helen Lavretsky, MD
Phone: 310-794-4619
Email: hlavrets@ucla.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

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