Recombinant Human Erythropoietin for Treating Treatment-Resistant Depression: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Trial
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Pharmacological treatments for depression have insufficient efficacy in 30-40% of patients and fail to reverse cognitive deficits. Erythropoietin (EPO) has neurotrophic actions and aids neurocognitive function. The aim of this exploratory study was to determine whether recombinant human EPO improves mood and memory in treatment-resistant depression. Forty treatment-resistant depressed unipolar patients with Hamilton Depression Rating Scale-17 (HDRS-17) score ≥ 17 were randomized to eight weekly EPO (Eprex; 40,000 IU) or saline infusions in a double-blind, placebo-controlled, parallel-group design. Patients were assessed at baseline and at weeks 5, 9, and 14. Primary outcome was reduction in HDRS-17 score. Global assessment of function (GAF) was reported in addition. Secondary outcome was remission rate, and tertiary outcomes were changes in Rey Auditory Verbal Learning Test (RAVLT), Beck Depression Inventory-21 (BDI-21), and World Health Organization Quality of life-BREF (WHOQOL-BREF). Exploratory outcomes were depression and cognition composite scores. HDRS-17, GAF, and remission rates showed no effects of EPO over saline at week 9 (P-value ≥ 0.09). However, EPO improved BDI (P=0.02) and WHOQOL-BREF (P=0.01), and this was maintained at follow-up week 14 (P-values ≤ 0.04). EPO enhanced verbal recall (P=0.02) and recognition (P=0.03), which was sustained at follow-up (P-values ≤ 0.04). Exploratory analysis in patients fulfilling depression severity criteria at trial start revealed ameliorated HDRS-17 in EPO (N=14) vs saline groups (N=17), which was sustained at week 14 (P-values ≤ 0.05). Exploratory analysis in the complete cohort showed that EPO reduced depression composite at weeks 9 and 14 (P-values=0.02). The findings of this exploratory study highlight EPO as an interesting compound for treatment-resistant depression, which deserves further investigation.
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Preliminary evidence indicates that erythropoietin may alleviate cognitive dysfunction in major depressive disorder.
“Preliminary evidence also indicates that erythropoietin may alleviate cognitive dysfunction in MDD.”
From Cognitive remission: a novel objective for the treatment of major depression? (2016) · cites this paper as [97]
In an RCT involving moderately depressed individuals with treatment-resistant major depressive disorder (n = 40), erythropoietin did not show effects distinct from placebo on the primary outcome measure of HDRS scores.
“Although EPO did not show effects distinct from those of a placebo on the primary outcome measure (i.e. HDRS scores), it produced long-term mood-independent improvement in verbal learning and memory on the RAVLT.”
From Cognitive remission: a novel objective for the treatment of major depression? (2016) · cites this paper as [97]
In the same RCT of treatment-resistant major depressive disorder, erythropoietin produced long-term mood-independent improvement in verbal learning and memory on the RAVLT.
“Although EPO did not show effects distinct from those of a placebo on the primary outcome measure (i.e. HDRS scores), it produced long-term mood-independent improvement in verbal learning and memory on the RAVLT.”
From Cognitive remission: a novel objective for the treatment of major depression? (2016) · cites this paper as [97]
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- Authors
- Miskowiak, K. W., Vinberg, M., Christensen, E. M., Bukh, J. D., Harmer, C. J., Ehrenreich, H., & Kessing, L. V.
- Affiliations
- Copenhagen University Hospital (DK)
- University of Oxford (GB)
- Max Planck Institute of Experimental Medicine (DE)
- Corresponding author
- Miskowiak, Kamilla W
- ORCID
- Venue
- Neuropsychopharmacology
- Published
- 2013-12-10
- Volume
- 39
- Issue
- 6
- Pages
- 1399-1408
- ISSN
- 0893-133X (ISSN-L)
- 1740-634X
- PMC
- PMC3988543
- OpenAlex
- W2016528779
- Cited by
- 104
- References
- 31
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 6 · 2023: 8 · 2022: 4 · 2021: 9 · 2020: 12 · 2019: 8 · 2018: 12 · 2017: 4 · 2016: 18 · 2015: 15 · 2014: 4
- FWCI
- 9.06
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Neuropsychopharmacology (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Max Planck Institute for Plasma Physics (submittedVersion)
- GRO (submittedVersion, cc-by)
- Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
- MPG.PuRe (Max Planck Society) (submittedVersion)
- Funders
- Lundbeckfonden (R67-2010-6154)
- Novo Nordisk
- Topics
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Health Sciences › Medicine › Hematology › Erythropoietin and Anemia Treatment
- Health Sciences › Medicine › Psychiatry and Mental health › Electroconvulsive Therapy Studies
- Keywords
- recombinant human erythropoietin, treatment-resistant depression, major depressive disorder, neurotrophic effects, cognitive function, verbal memory, quality of life, depression severity, remission
- MeSH terms
- Adult, Affect, Antidepressive Agents, Double-Blind Method, Erythropoietin, Female, Follow-Up Studies, Humans, Male, Memory, Middle Aged, Psychiatric Status Rating Scales, Recombinant Proteins, Remission Induction, Time Factors, Treatment Outcome, Depressive Disorder, Treatment-Resistant
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