Trial of Levomilnacipran in Geriatric Depression

Completed · Phase 4 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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

Key facts

Study ID

NCT02466958

Run by

University of California, Los Angeles

People needed

29

Starts

2016-06-01

Expected to finish

2018-12-09

Last updated by the study team

2019-08-14

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• UCLA Semel Institute - Neuropsychiatric Institute (NPI) — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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