Trial of Levomilnacipran in Geriatric Depression (LMIL)
Major Depressive Disorder
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring depressed, older adults, antidepressants, depression, MDD
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)
Sites / Locations
- UCLA Semel Institute - Neuropsychiatric Institute (NPI)
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
levomilnacipran (FETZIMA)
Placebo
All eligible subjects will be randomized to levomilnacipran or placebo group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups.
All eligible subjects will be randomized to levomilnacipran or placebo group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups.