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Trials / Completed

CompletedNCT00916552

Effects of Erythropoietin on Depressive Symptoms and Neurocognitive Deficits in Depression and Bipolar Disorder

The Effects of Erythropoietin on Depressive Symptoms and Neurocognitive Deficits in Patients With Treatment Resistant Depression and in Patients With Remitted Bipolar Disorder - a Proof of Concept Study

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
83 (actual)
Sponsor
Lars Vedel Kessing, professor, MD, DMSc. · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DRUGErythropoietin40.000 IU/ml epoetin alfa is administered as intravenous infusions over 15 min weekly for 8 weeks.

Timeline

Start date
2009-09-01
Primary completion
2012-10-01
Completion
2012-10-01
First posted
2009-06-09
Last updated
2012-11-09

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT00916552. Inclusion in this directory is not an endorsement.

Effects of Erythropoietin on Depressive Symptoms and Neurocognitive Deficits in Depression and Bipolar Disorder (NCT00916552) · Clinical Trials Directory