Effects of erythropoietin (EPO) on cognitive side-effects of electroconvulsive therapy (ECT) (EPO-T)

Phase 1

• Conditions: nipolar/bipolar depression; MedDRA version: 21.1Level: LLTClassification code 10045543Term: Unipolar depressionSystem Organ Class: 100000004873; MedDRA version: 21.1Level: LLTClassification code 10004936Term: Bipolar depressionSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2016-002326-36-DK
• Lead Sponsor: Region Hovedstadens psykiatriske hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-28
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

We will recruit patients with unipolar or bipolar depression who are
scheduled for ECT treatment at Psychiatric Centre Copenhagen and
Psychiatric Centre Frederiksberg (and other centers in the Capitol Region
if necessary). Patients will be screened with Mini Mental Neuropsychiatric Interview (M.I.N.I.) to confirm ICD-10 diagnosis.
Eligible patients are between 18-70 years old and have a diagnosis of
major depression (MDD) unipolar or bipolar (BD) with current moderate
to severe depressive symptoms. They should have a Hamilton
Depression Rating Scale 17-items (HDRS-17) score =17, have Danish as
their native language and be able to give informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Exclusion criteria are: treatment under involuntary measures, previous ECT within the last three months, other neuropsychiatric conditions,
alcohol or substance misuse disorder. To ensure safety of EPO treatment, patients are also excluded if they have a significant medical
condition (incl. diabetes, renal failure, epilepsy, hypertension,
malignancies or thromboses), pregnancy, contraceptive
medication or a family history of thromboses or seizures.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified