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Effects of Erythropoietin for Cognitive Side-effects of ECT

NCT03339596 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-09-21

No results posted yet for this study

Summary

EPO-T aims to investigate (i) whether short-term add-on treatment with erythropoietin (EPO) can reduce cognitive side-effects of ECT and (ii) whether such effects are long-lasting. Further, structural and functional magnetic resonance imaging (MRI) will be used to explore the neural underpinnings of such beneficial effects of EPO. Finally, the trial examines whether potential protective effects of EPO on cognition are accompanied by changes in markers of oxidative stress, inflammation, and neuroplasticity.

It is hypothesized that EPO treatment will (i) counteract ECT-induced cognitive decline, accompanied by (ii) increased sub-regional hippocampal volume, (iii) greater memory-related hippocampal activation and reinforcement of dorsolateral prefrontal activity during memory encoding and working memory, and (iv) changes in peripheral markers of inflammation, oxidative stress and neuroplasticity. Furthermore, we hypothesize that add-on EPO-treatment will produce greater, more sustained mood improvement than ECT treatment alone.

Conditions

Interventions

DRUG

Erythropoietin

40.000 IU/ml Erythropoietin (Epoetin alpha; Eprex) diluted with 100 ml saline (0.9% NaCl) is administered 4 times as intravenous infusions over 15 minutes.

DRUG

Saline

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

Sponsors & Collaborators

  • The Augustinus Foundation, Denmark.

    collaborator OTHER

  • Mental Health Services in the Capital Region, Denmark

    collaborator OTHER

  • Martin Balslev Jørgensen

    lead OTHER

Principal Investigators

  • Martin B. Jørgensen, Prof. · Psychiatric Centre Copenhagen, Rigshospitalet

  • Kamilla W. Miskowiak, Prof. · Psychiatric Centre Copenhagen, Rigshospitalet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-26
Primary Completion
2023-01-10
Completion
2023-02-10

Countries

  • Denmark

Study Locations

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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 NCT03339596 on ClinicalTrials.gov