Recombinant Human Erythropoietin for Treating Treatment-Resistant Depression: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Trial

Research output: Contribution to journalJournal articlepeer-review

Standard

Recombinant Human Erythropoietin for Treating Treatment-Resistant Depression : A Double-Blind, Randomized, Placebo-Controlled Phase 2 Trial. / Miskowiak, Kamilla W; Vinberg, Maj; Christensen, Ellen M; Bukh, Jens Otto Drachmann; Harmer, Catherine J; Ehrenreich, Hannelore; Kessing, Lars V.

In: Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, Vol. 39, No. 6, 2014, p. 1399-1408.

Research output: Contribution to journalJournal articlepeer-review

Harvard

Miskowiak, KW, Vinberg, M, Christensen, EM, Bukh, JOD, Harmer, CJ, Ehrenreich, H & Kessing, LV 2014, 'Recombinant Human Erythropoietin for Treating Treatment-Resistant Depression: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Trial', Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, vol. 39, no. 6, pp. 1399-1408. https://doi.org/10.1038/npp.2013.335

APA

Miskowiak, K. W., Vinberg, M., Christensen, E. M., Bukh, J. O. D., Harmer, C. J., Ehrenreich, H., & Kessing, L. V. (2014). Recombinant Human Erythropoietin for Treating Treatment-Resistant Depression: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Trial. Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, 39(6), 1399-1408. https://doi.org/10.1038/npp.2013.335

Vancouver

Miskowiak KW, Vinberg M, Christensen EM, Bukh JOD, Harmer CJ, Ehrenreich H et al. Recombinant Human Erythropoietin for Treating Treatment-Resistant Depression: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Trial. Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology. 2014;39(6):1399-1408. https://doi.org/10.1038/npp.2013.335

Author

Miskowiak, Kamilla W ; Vinberg, Maj ; Christensen, Ellen M ; Bukh, Jens Otto Drachmann ; Harmer, Catherine J ; Ehrenreich, Hannelore ; Kessing, Lars V. / Recombinant Human Erythropoietin for Treating Treatment-Resistant Depression : A Double-Blind, Randomized, Placebo-Controlled Phase 2 Trial. In: Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology. 2014 ; Vol. 39, No. 6. pp. 1399-1408.

Bibtex

@article{7ae0856b1c5443d19102b9cd51041843,
title = "Recombinant Human Erythropoietin for Treating Treatment-Resistant Depression: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Trial",
abstract = "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.",
keywords = "Adult, Affect, Antidepressive Agents, Depressive Disorder, Treatment-Resistant, 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",
author = "Miskowiak, {Kamilla W} and Maj Vinberg and Christensen, {Ellen M} and Bukh, {Jens Otto Drachmann} and Harmer, {Catherine J} and Hannelore Ehrenreich and Kessing, {Lars V}",
year = "2014",
doi = "10.1038/npp.2013.335",
language = "English",
volume = "39",
pages = "1399--1408",
journal = "Neuropsychopharmacology",
issn = "0893-133X",
publisher = "nature publishing group",
number = "6",

}

RIS

TY - JOUR

T1 - Recombinant Human Erythropoietin for Treating Treatment-Resistant Depression

T2 - A Double-Blind, Randomized, Placebo-Controlled Phase 2 Trial

AU - Miskowiak, Kamilla W

AU - Vinberg, Maj

AU - Christensen, Ellen M

AU - Bukh, Jens Otto Drachmann

AU - Harmer, Catherine J

AU - Ehrenreich, Hannelore

AU - Kessing, Lars V

PY - 2014

Y1 - 2014

N2 - 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.

AB - 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.

KW - Adult

KW - Affect

KW - Antidepressive Agents

KW - Depressive Disorder, Treatment-Resistant

KW - Double-Blind Method

KW - Erythropoietin

KW - Female

KW - Follow-Up Studies

KW - Humans

KW - Male

KW - Memory

KW - Middle Aged

KW - Psychiatric Status Rating Scales

KW - Recombinant Proteins

KW - Remission Induction

KW - Time Factors

KW - Treatment Outcome

U2 - 10.1038/npp.2013.335

DO - 10.1038/npp.2013.335

M3 - Journal article

C2 - 24322509

VL - 39

SP - 1399

EP - 1408

JO - Neuropsychopharmacology

JF - Neuropsychopharmacology

SN - 0893-133X

IS - 6

ER -

ID: 138312971