drugset / Trial / NCT03315897

Effects of Erythropoietin on Cognition and Neural Activity in Mood Disorders

NCT03315897

RandomizedParallel-groupSingle-blindTreatment

Summary

The present trial consists of 2 sub-studies that investigate important novel aspects of treatment with erythropoietin (EPO) on cognitive dysfunction in bipolar disorder (BD) and recurrent unipolar depressive disorder (UD) (defined as minimum 2 treatment-requiring depressive episodes). The aims of the trial are three-fold. We aim to investigate the effects of 12 weekly recombinant human EPO infusions on cognition in (i) healthy people with cognitive impairment (substudy 1) and (ii) patients with remitted BD or recurrent UD (substudy 2), and (iii) explore early treatment-associated neural activity changes that may predict subsequent cognitive improvement. It is hypothesized that: i. 12 weekly EPO infusions improve cognition in healthy first-degree relatives and remitted BD patients in comparison with saline. ii. EPO vs. saline-treated participants will display early cognition-related neural activity in the frontal lobes, which will correlate with cognitive improvement.

Timeline

Start
2017-07-05
Primary completion
2022-10-01
Completion
2022-10-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator epoetin alfa Protein / enzyme biologic 40000 iu Intravenous