CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 83 enrolled
Drug / intervention
Erythropoietindrug
Likely dose
Erythropoietin 40.000 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00916552
NCT00916552Phase 2Completed

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

Lars Vedel Kessing, professor, MD, DMSc.·interventional·Posted Jun 9, 2009·Updated Nov 9, 2012

In Brief

A Phase 2 clinical trial evaluating Erythropoietin for Mood Disorders. Completed, enrolled 83 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMood Disorders
CountriesDenmark

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 9, 2009
Enrollment StartSep 1, 2009
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 17.1 years ago

Interventions

Erythropoietindrug

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