A Phase 2 interventional study of Erythropoietin in Mood Disorders, sponsored by Lars Vedel Kessing, professor, MD, DMSc.. Completed at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-11-09.
Sponsored by Lars Vedel Kessing, professor, MD, DMSc. · Phase 2, Interventional, and Treatment
Depression and bipolar disorder (mania and depression) may be related to problems with nerve cells not being regenerated as fast as normal and are accompanied by cognitive difficulties including memory, attention and planning problems. There is thus a need for better, more efficient treatments with effects on cognitive function. Erythropoietin (Epo) is involved in brain repair and may be a candidate for future treatment strategies. The investigators have demonstrated that a single dose of Epo improves mood and reduces the processing of negative emotional information in healthy volunteers similar to effects seen with antidepressants. With the current study the investigators aim to build upon this discovery by investigating whether repeated Epo administration has antidepressant effects and is able to reverse cognitive difficulties in patients with depression or bipolar disorder. It is hypothesized that Epo will improve mood in treatment-resistant depression and improve cognitive function in this group and in patients with bipolar disorder in remission. If the study reveals beneficial effects of Epo, this would highlight Epo as a candidate compound for future treatment of depression and bipolar disorder, with the potential to directly promote brain repair mechanisms.
8,055 studies on the registry are indexed under Depression; 1,643 are open to participants now.
This study's enrollment of 83 is close to the median of 84 across 6,718 interventional studies indexed under Depression.
Browse Depression studies →This is the only study on the registry with Lars Vedel Kessing, professor, MD, DMSc. as lead sponsor.
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OR
Exclusion Criteria:
40.000 IU, epoetin alfa; Janssen-Cilag
Drug: Erythropoietin
40.000 IU/ml epoetin alfa is administered as intravenous infusions over 15 min weekly for 8 weeks.
Also known as: Eprex, Epo
a) For treatment-resistant depressed patients: Antidepressant effect measured with the Hamilton Depression Rating Scale (HDRS); b) For bipolar patients in remission: Memory measured with the Rey Auditory Verbal Memory Test.
Time frame: a) Baseline and weeks 5, 9 and 14; b) Baseline and weeks 9 and 14
a) For treatment-resistant depressed patients: number of remissions measured with the HDRS; b) For bipolar patients in remission: sustained attention measured with the RVIP and facial expression recognition.
Time frame: a) Baseline and weeks 5, 9 and 14; b) Baseline and weeks 9 and 14
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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