Effects of Erythropoietin on Depressive Symptoms and Neurocognitive Deficits in Depression and Bipolar Disorder
NCT ID: NCT00916552
Last Updated: 2012-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
83 participants
INTERVENTIONAL
2009-09-30
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Erythropoeitin
40.000 IU, epoetin alfa; Janssen-Cilag
Erythropoietin
40.000 IU/ml epoetin alfa is administered as intravenous infusions over 15 min weekly for 8 weeks.
Interventions
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Erythropoietin
40.000 IU/ml epoetin alfa is administered as intravenous infusions over 15 min weekly for 8 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
OR
* Bipolar disorder in remission (HDRS score of max 14 and Young Mania Scale score of max 14) and subjective complaints of moderate to severe cognitive problems on the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) (Fava et al 2006) (score at least 4 on at least 2 domains)
* Unchanged antidepressant or mood stabilizing treatment for at least 2 weeks prior to and during the study
Exclusion Criteria
* Dependence on or abuse of drugs (including alcohol and benzodiazepines corresponding to more than 22.5 mg Oxazepam daily)
* Diabetes
* Renal failure
* Smoking
* Major surgery within 4 weeks prior to inclusion
* Previous Epo-treatment
* Known allergy or antibodies against Epo
* Present or past malignancies
* Epilepsy or epilepsy in first degree family Diagnosis (past or present) of a cardiovascular or cerebrovascular disease
* Untreated or not sufficiently treated arterial hypertension ("therapy-resistant hypertension")
* Initial hematocrit \> 50% (males) or \> 48% (females)
* Initial platelet count above normal range of laboratory
* Initial reticulocyte count below norma range of laboratory
* Past thromboembolic events or thromboembolic events in first degree family (increased thromboembolic risk)
* Contraindications against prophylactic thrombosis treatment
* Myeloproliferative disorder, polycythemia
* Present immunosuppressive treatment with cyclosporin
* Overweight (BMI \> 30) or body weight of less than 45 kg or over 95 kg
* Acute suicidal risk, present or previous suicide attempts in the past 2 years
* Pregnancy or breast feeding
* Women who presently use contraceptive pills
* Sexually active women with child bearing potential who refuse to use double barrier anticonception methods
* Unwillingness or inability to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol
* Present illness which in investigator's opinion could affect the patient's participation in the study
18 Years
65 Years
ALL
No
Sponsors
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The Ministry of Science, Technology and Innovation, Denmark
OTHER_GOV
Novo Nordisk A/S
INDUSTRY
University of Oxford
OTHER
Max-Planck-Institute of Experimental Medicine
OTHER
Lars Vedel Kessing, professor, MD, DMSc.
OTHER
Responsible Party
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Lars Vedel Kessing, professor, MD, DMSc.
Professor
Principal Investigators
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Lars V Kessing, Professor
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Copenhagen University Hospital, Rigshospitalet
Copenhagen, , Denmark
Countries
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References
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Miskowiak KW, Forman JL, Vinberg M, Siebner HR, Kessing LV, Macoveanu J. Impact of pretreatment interhemispheric hippocampal asymmetry on improvement in verbal learning following erythropoietin treatment in mood disorders: a randomized controlled trial. J Psychiatry Neurosci. 2020 May 1;45(3):198-205. doi: 10.1503/jpn.180205.
Miskowiak KW, Rush AJ Jr, Gerds TA, Vinberg M, Kessing LV. Targeting Treatments to Improve Cognitive Function in Mood Disorder: Suggestions From Trials Using Erythropoietin. J Clin Psychiatry. 2016 Dec;77(12):e1639-e1646. doi: 10.4088/JCP.15m10480.
Miskowiak KW, Macoveanu J, Vinberg M, Assentoft E, Randers L, Harmer CJ, Ehrenreich H, Paulson OB, Knudsen GM, Siebner HR, Kessing LV. Effects of erythropoietin on memory-relevant neurocircuitry activity and recall in mood disorders. Acta Psychiatr Scand. 2016 Sep;134(3):249-59. doi: 10.1111/acps.12597. Epub 2016 Jun 3.
Miskowiak KW, Vinberg M, Glerup L, Paulson OB, Knudsen GM, Ehrenreich H, Harmer CJ, Kessing LV, Siebner HR, Macoveanu J. Neural correlates of improved executive function following erythropoietin treatment in mood disorders. Psychol Med. 2016 Jun;46(8):1679-91. doi: 10.1017/S0033291716000209. Epub 2016 Mar 21.
Vinberg M, Miskowiak K, Hoejman P, Pedersen M, Kessing LV. The effect of recombinant erythropoietin on plasma brain derived neurotrophic factor levels in patients with affective disorders: a randomised controlled study. PLoS One. 2015 May 26;10(5):e0127629. doi: 10.1371/journal.pone.0127629. eCollection 2015.
Miskowiak KW, Vinberg M, Macoveanu J, Ehrenreich H, Koster N, Inkster B, Paulson OB, Kessing LV, Skimminge A, Siebner HR. Effects of Erythropoietin on Hippocampal Volume and Memory in Mood Disorders. Biol Psychiatry. 2015 Aug 15;78(4):270-7. doi: 10.1016/j.biopsych.2014.12.013. Epub 2014 Dec 18.
Miskowiak KW, Ehrenreich H, Christensen EM, Kessing LV, Vinberg M. Recombinant human erythropoietin to target cognitive dysfunction in bipolar disorder: a double-blind, randomized, placebo-controlled phase 2 trial. J Clin Psychiatry. 2014 Dec;75(12):1347-55. doi: 10.4088/JCP.13m08839.
Miskowiak KW, Vinberg M, Harmer CJ, Ehrenreich H, Knudsen GM, Macoveanu J, Hansen AR, Paulson OB, Siebner HR, Kessing LV. Effects of erythropoietin on depressive symptoms and neurocognitive deficits in depression and bipolar disorder. Trials. 2010 Oct 13;11:97. doi: 10.1186/1745-6215-11-97.
Other Identifiers
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EPO1
Identifier Type: -
Identifier Source: org_study_id