Effects of erythropoietin on depressive symptoms and neurocognitive deficits in depression and bipolar disorder
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Effects of erythropoietin on depressive symptoms and neurocognitive deficits in depression and bipolar disorder. / Miskowiak, Kamilla W; Vinberg, Maj; Harmer, Catherine J; Ehrenreich, Hannelore; Knudsen, Gitte M; Macoveanu, Julian; Hansen, Allan R; Paulson, Olaf B; Siebner, Hartwig R; Kessing, Lars V.
In: Trials, Vol. 11, 01.01.2010, p. 97.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Effects of erythropoietin on depressive symptoms and neurocognitive deficits in depression and bipolar disorder
AU - Miskowiak, Kamilla W
AU - Vinberg, Maj
AU - Harmer, Catherine J
AU - Ehrenreich, Hannelore
AU - Knudsen, Gitte M
AU - Macoveanu, Julian
AU - Hansen, Allan R
AU - Paulson, Olaf B
AU - Siebner, Hartwig R
AU - Kessing, Lars V
PY - 2010/1/1
Y1 - 2010/1/1
N2 - BACKGROUND: Depression and bipolar disorder are associated with reduced neural plasticity and deficits in memory, attention and executive function. Drug treatments for these affective disorders have insufficient clinical effects in a large group and fail to reverse cognitive deficits. There is thus a need for more effective treatments which aid cognitive function. Erythropoietin (Epo) is involved in neuroplasticity and is a candidate for future treatment of affective disorders. The investigators have demonstrated that a single dose of Epo improves cognitive function and reduces neurocognitive processing of negative emotional information in healthy and depressed individuals similar to effects seen with conventional antidepressants. The current study adds to the previous findings by investigating whether repeated Epo administration has antidepressant effects in patients with treatment resistant depression and reverses cognitive impairments in these patients and in patients with bipolar disorder in remission. METHODS/DESIGN: The trial has a double-blind, placebo-controlled, parallel-group design. 40 patients with treatment-resistant major depression and 40 patients with bipolar disorder in remission are recruited and randomised to receive weekly infusions of Epo (Eprex; 40,000 IU) or saline (NaCl 0.9%) for 8 weeks. Randomisation is stratified for age and gender. The primary outcome parameters for the two studies are: depression severity measured with the Hamilton Depression Rating Scale 17 items (HDRS-17) 1 in study 1 and, in study 2, verbal memory measured with the Rey Auditory Verbal Learning Test (RAVLT) 23. With inclusion of 40 patients in each study we obtain 86% power to detect clinically relevant differences between intervention and placebo groups on these primary outcomes. TRIAL REGISTRATION: The trial is approved by the Local Ethics Committee: H-C-2008-092, Danish Medicines Agency: 2612-4020, EudraCT: 2008-04857-14, Danish Data Agency: 2008-41-2711 and ClinicalTrials.gov: NCT 00916552.
AB - BACKGROUND: Depression and bipolar disorder are associated with reduced neural plasticity and deficits in memory, attention and executive function. Drug treatments for these affective disorders have insufficient clinical effects in a large group and fail to reverse cognitive deficits. There is thus a need for more effective treatments which aid cognitive function. Erythropoietin (Epo) is involved in neuroplasticity and is a candidate for future treatment of affective disorders. The investigators have demonstrated that a single dose of Epo improves cognitive function and reduces neurocognitive processing of negative emotional information in healthy and depressed individuals similar to effects seen with conventional antidepressants. The current study adds to the previous findings by investigating whether repeated Epo administration has antidepressant effects in patients with treatment resistant depression and reverses cognitive impairments in these patients and in patients with bipolar disorder in remission. METHODS/DESIGN: The trial has a double-blind, placebo-controlled, parallel-group design. 40 patients with treatment-resistant major depression and 40 patients with bipolar disorder in remission are recruited and randomised to receive weekly infusions of Epo (Eprex; 40,000 IU) or saline (NaCl 0.9%) for 8 weeks. Randomisation is stratified for age and gender. The primary outcome parameters for the two studies are: depression severity measured with the Hamilton Depression Rating Scale 17 items (HDRS-17) 1 in study 1 and, in study 2, verbal memory measured with the Rey Auditory Verbal Learning Test (RAVLT) 23. With inclusion of 40 patients in each study we obtain 86% power to detect clinically relevant differences between intervention and placebo groups on these primary outcomes. TRIAL REGISTRATION: The trial is approved by the Local Ethics Committee: H-C-2008-092, Danish Medicines Agency: 2612-4020, EudraCT: 2008-04857-14, Danish Data Agency: 2008-41-2711 and ClinicalTrials.gov: NCT 00916552.
KW - Affect
KW - Antidepressive Agents
KW - Attention
KW - Bipolar Disorder
KW - Clinical Protocols
KW - Cognition
KW - Denmark
KW - Depressive Disorder, Major
KW - Double-Blind Method
KW - Erythropoietin
KW - Executive Function
KW - Humans
KW - Memory
KW - Neuronal Plasticity
KW - Neuropsychological Tests
KW - Placebo Effect
KW - Psychiatric Status Rating Scales
KW - Questionnaires
KW - Research Design
KW - Time Factors
KW - Treatment Outcome
U2 - 10.1186/1745-6215-11-97
DO - 10.1186/1745-6215-11-97
M3 - Journal article
C2 - 20942940
VL - 11
SP - 97
JO - Trials
JF - Trials
SN - 1745-6215
ER -
ID: 33434526