At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 29 enrolled
Drug / intervention
levomilnacipran +1 moredrug
Likely dose
Not stated in record
Key inclusion· 4
- ✓Age 60 years or older
- ✓Major depressive disorder diagnosed by DSM-5 criteria
- ✓HAMD score ≥16 at baseline
- ✓MMSE score >24
Key exclusion· 11
- ✕Current or lifetime history of other psychiatric disorders except unipolar depression with or without comorbid generalized anxiety disorder
- ✕Recent unstable medical or neurological disorders
- ✕Disabilities preventing participation in the study or MRI
- ✕Diagnosis of dementia
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Double-blind Placebo-controlled Trial of Levomilnacipran in Geriatric Depression
In Brief
A Phase 4 clinical trial evaluating levomilnacipran and Placebo for Major Depressive Disorder. Completed, enrolled 29 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2015
Enrollment StartJun 2016
Primary CompletionDec 2018
TodayJul 2026
First PostedJun 9, 2015
Enrollment StartJun 1, 2016
Primary CompletionDec 9, 2018
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 11.1 years ago
Interventions
levomilnaciprandrug
antidepressant
Placebodrug
an inactive drug