Trial of Levomilnacipran in Geriatric Depression
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02466958 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- levomilnacipran (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hamilton Depression Rating Scale (HDRS) Scores 24 |
17.88; 19.92; 6.86; 10.33 | — |
| SECONDARY Clinical Global Impression Scale (CGI) Scores |
3.00; 3.33 | — |
| SECONDARY Geriatric Depression (GDS) Scores |
13.5; 15.33; 11.71; 11.33 | — |
Summary
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)
Data sourced from ClinicalTrials.gov (NCT02466958). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.