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Phase 4 Completed N=29 Randomized Double-blind Treatment

Trial of Levomilnacipran in Geriatric Depression

Source: ClinicalTrials.gov NCT02466958 ↗
Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Hamilton Depression Rating Scale (HDRS) Scores 24 — 17.88; 19.92; 6.86; 10.33 units on a scale
◆ Published Evidence
Established
40citations · ~7 / year
Cortical thickness increases with levomilnacipran treatment in a pilot randomised double-blind placebo-controlled trial in late-life depression.
Psychogeriatrics : the official journal of the Japanese Psychogeriatric Society · 2020 · High-confidence link

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.

Linked Publications (2)

  • Cortical thickness increases with levomilnacipran treatment in a pilot randomised double-blind placebo-controlled trial in late-life depression.
    Psychogeriatrics : the official journal of the Japanese Psychogeriatric Society · 2020 · 12 citations · High-confidence link
  • The intestinal microbiota as a predictor for antidepressant treatment outcome in geriatric depression: a prospective pilot study.
    International psychogeriatrics · 2022 · 40 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-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

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02466958) and the linked publication. 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. Informational only — not medical advice.

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