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Cited by 81Treatment of Major DepressionAnxiety, Depression, Psychometrics, Treatment, Cognitive ProcessesPsychological Treatments and Disorders

Efficacy and tolerability of the novel triple reuptake inhibitor amitifadine in the treatment of patients with major depressive disorder: A randomized, double-blind, placebo-controlled trial

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Tran, Pierre, Skolnick, Phil, Czobor, Pal, Huang, N.Y., Bradshaw, Mark, McKinney, Anthony, Fava, Maurizio·2012·Journal of Psychiatric Research
DOI 10.1016/j.jpsychires.2011.09.003
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Abstract

Amitifadine (EB-1010, formerly DOV 21,947) is a serotonin-preferring triple reuptake inhibitor with a relative potency to inhibit serotonin, norepinephrine, and dopamine uptake of ∼1:2:8, respectively. This 6-week, multicenter, randomized, double-blind, parallel, placebo-controlled study evaluated the efficacy and tolerability of amitifadine in 63 patients with major depressive disorder. Eligible patients (17-item Hamilton Depression Rating Scale [HAMD-17] ≥ 22 at baseline) were randomized to amitifadine 25 mg twice daily (BID) for 2 weeks, then 50 mg BID for 4 weeks or placebo. Mean baseline scores in the modified intent-to-treat population (n = 56) were 31.4 for the Montgomery-Åsberg Depression Rating Scale (MADRS), 29.6 for the HAMD-17, and 25.4 for the Derogatis Interview for Sexual Functioning - Self Report (DISF-SR). At the end of the 6-week double-blind treatment, estimated least squares mean change from baseline (mixed-model repeated measures [MMRM]) in MADRS total score was statistically significantly superior for amitifadine compared to placebo (18.2 vs. 22.0; p = 0.028), with an overall statistical effect size of -0.601 (Cohen's d). Amitifadine also was statistically significantly superior to placebo (p = 0.03) for the Clinical Global Impression of Change - Improvement. An anhedonia factor score grouping of MADRS Items 1 (apparent sadness), 2 (reported sadness), 6 (concentration difficulties), 7 (lassitude), and 8 (inability to feel) demonstrated a statistically significant difference in favor of amitifadine compared to placebo (p = 0.049). No differences were observed between treatments in DISF-SR scores. Amitifadine was well-tolerated. Two patients on each treatment discontinued the study early due to adverse events; however, no serious adverse events were reported. This initial clinical trial in patients with severe major depression demonstrated significant antidepressant activity with amitifadine, including attenuating symptoms of anhedonia, and a tolerability profile that was comparable to placebo. The efficacy and tolerability of amitifadine for major depressive disorder are being investigated in additional clinical trials.

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Authors
Tran, P., Skolnick, P., Czobor, P., Huang, N. Y., Bradshaw, M., McKinney, A., & Fava, M.
ORCID
Venue
Journal of Psychiatric Research
Publisher
Elsevier BV
Published
2012-01
Volume
46
Issue
1
Pages
64-71
ISSN
0022-3956 (ISSN-L)
DOI
10.1016/j.jpsychires.2011.09.003
OpenAlex
W1981648956
Cited by
81
References
68
Citations by year
2025: 3 · 2024: 1 · 2023: 5 · 2022: 5 · 2021: 3 · 2020: 2 · 2019: 5 · 2018: 1 · 2017: 5 · 2016: 3 · 2015: 13 · 2014: 8 · 2013: 16 · 2012: 10
FWCI
8.20
Type
journal article
Language
en
Open access
Licence
Locations
  • Journal of Psychiatric Research (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • Semmelweis University Repository (Semmelweis University) (submittedVersion)
Funders
Euthymics Bioscience
Topics
  • Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
  • Social Sciences › Psychology › Clinical Psychology › Psychological Treatments and Disorders
Keywords
major depressive disorder, triple reuptake inhibitors, antidepressant efficacy, tolerability, anhedonia, sexual dysfunction, serotonin, norepinephrine, dopamine, treatment-resistant depression, adverse events, mood stabilizers, lithium, valproic acid
MeSH terms
Adolescent, Adult, Aged, Antidepressive Agents, Aza Compounds, Major Depressive Disorder, Double-Blind Method, Female, Follow-Up Studies, Humans, International Cooperation, Male, Middle Aged, Psychiatric Status Rating Scales, Treatment Outcome, Bridged Bicyclo Compounds, Heterocyclic, Young Adult

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