Trial of Levomilnacipran in Geriatric Depression

• Status: Completed
• Trial end date: 2018-12-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Treatments: Levomilnacipran; Milnacipran

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)