Status:
COMPLETED
Effects of Erythropoietin for Cognitive Side-effects of ECT
Lead Sponsor:
Martin Balslev Jørgensen
Collaborating Sponsors:
The Augustinus Foundation, Denmark.
Mental Health Services in the Capital Region, Denmark
Conditions:
ECT
Cognitive Impairment
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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...
Detailed Description
The trial will include patients with a diagnosis of major depression (MDD) unipolar disorder (UD) or bipolar disorder (BD) with a current moderate to severe depressive episode symptoms (a score of \>1...
Eligibility Criteria
Inclusion
- ICD-10 diagnosis of major depressive disorder/unipolar disorder or bipolar disorder (confirmed using the Mini International Neuropsychiatric Interview; M.I.N.I.) with current moderate to severe depressive episode symptoms
- Hamilton Depression Rating Scale 17-items score ≥17
- Fluent Danish skills
Exclusion
- Treatment under involuntary measures
- Other neuropsychiatric conditions
- Alcohol or substance misuse disorder
- Recent suicide attempts
- Diabetes
- Kidney disease
- Renal failure
- Untreated/insufficiently treated arterial hypertension
- Heart diseases (previously diagnosed or abnormal ECG findings during screening)
- Previous or current epilepsy in patient or first degree family
- Malignancies or thromboses
- Known allergy or antibodies against erythropoietin
- Initial hematocrit \> 50% (males) or \> 48% (females)
- Initial thrombocyte numbers over normal (\>400 billions/L)
- Initial reticulocyte numbers \<1‰
- Contraindications against prophylactic thrombosis treatment
- Myeloproliferative disorder, polycythemia
- Pregnancy or breast feeding
- Use of contraceptive medication or other hormonal contraceptives
- Sexually active women in the fertile age, who do not or do not want to use double barrier anticontraceptive methods
- Previous or current history of thromboembolic events or thromboses in patient or first degree family (increased risk of thromboembolic events)
- Overweight (BMI\>30) or body weight \<45 or \>95 kg.
- Previous electroconvulsive therapy (ECT) treatment within last 3 months
- Reluctance or inability to comply with the protocol requirements
Key Trial Info
Start Date :
June 26 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03339596
Start Date
June 26 2017
End Date
February 10 2023
Last Update
September 21 2023
Active Locations (1)
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1
Mental Health Services, Capital Region of Denmark, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Copenhagen O, Denmark, 2100