Effects of Erythropoietin for Cognitive Side-effects of ECT

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Martin Balslev Jørgensen
• Collaborators: Mental Health Services in the Capital Region, Denmark; The Augustinus Foundation, Denmark.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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