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Effects of Erythropoietin on Cognition and Neural Activity in Mood Disorders

NCT03315897 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2023-03-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Erythropoietin

40.000 IU/ml Erythropoietin (Epoetin alpha; Eprex) diluted with 100 ml saline (0.9% NaCl) is administered 12 times as intravenous infusions over 15 minutes.

DRUG

Saline

1 ml NaCl is administered 4 times as intravenous infusions over 15 minutes

Sponsors & Collaborators

  • Mental Health Services in the Capital Region, Denmark

    collaborator OTHER

  • Lundbeck Foundation

    collaborator OTHER

  • Lars Vedel Kessing

    lead OTHER

Principal Investigators

  • Lars V. Kessing, Prof. · Mental Health Services, Capital Region of Denmark, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark, 2100

  • Kamilla W. Miskowiak, Prof. · Mental Health Services, Capital Region of Denmark, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark, 2100

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03315897 on ClinicalTrials.gov