Clinical trial NCT02466958: Trial of Levomilnacipran in Geriatric Depression
Official title: Double-blind Placebo-controlled Trial of Levomilnacipran in Geriatric Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: depressed
older adults
antidepressants
depression
MDD
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2015-06-09
Enrollment: 29
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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 40 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 40 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.

Eligibility criteria: Inclusion Criteria:

* 60 years of age or older
* The presence of a major depressive disorder diagnosed according to the Diagnostic and Statistical Manual and Mental Disorders, 5th edition (DSM-V) criteria
* A 24-item Hamilton Rating Scale for Depression (HAMD) score of 16 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 monoamine oxidase inhibitors (MAOIs) within last 4 weeks; 7) ineligible for MRI (e.g., metal in the body or claustrophobia)

Primary outcomes:
measure: Hamilton Depression Rating Scale (HDRS) Scores 24
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Clinical Global Impression Scale (CGI) Scores
timeFrame: Week 12 reported
measure: Geriatric Depression (GDS) Scores
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Semel Institute - Neuropsychiatric Institute (NPI)
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Helen Lavretsky, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krause-Sorio B, Kilpatrick L, Siddarth P, Ercoli L, Laird KT, Aguilar-Faustino Y, Milillo MM, Narr KL, Lavretsky H. Cortical thickness increases with levomilnacipran treatment in a pilot randomised double-blind placebo-controlled trial in late-life depression. Psychogeriatrics. 2020 Mar;20(2):140-148. doi: 10.1111/psyg.12475. Epub 2019 Jul 22.
citation: Lee SM, Dong TS, Krause-Sorio B, Siddarth P, Milillo MM, Lagishetty V, Datta T, Aguilar-Faustino Y, Jacobs JP, Lavretsky H. The intestinal microbiota as a predictor for antidepressant treatment outcome in geriatric depression: a prospective pilot study. Int Psychogeriatr. 2022 Jan;34(1):33-45. doi: 10.1017/S1041610221000120. Epub 2021 Mar 24.