Cognitive Impairment Clinical Trial
— EPO-TOfficial title:
Erythropoietin as an add-on Treatment for Cognitive Side-effects of Electroconvulsive Therapy
Verified date | September 2023 |
Source | Mental Health Services in the Capital Region, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | February 10, 2023 |
Est. primary completion date | January 10, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Mental Health Services, Capital Region of Denmark, Copenhagen University Hospital, Rigshospitalet | Copenhagen | Copenhagen O |
Lead Sponsor | Collaborator |
---|---|
Martin Balslev Jørgensen | Mental Health Services in the Capital Region, Denmark, The Augustinus Foundation, Denmark. |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Rey Auditory Verbal Learning Test (RAVLT) | Neuropsychological test assessing verbal learning and memory | Baseline, week 4 (i.e., after the last EPO injection and 8th ECT session), and 3 months after ECT treatment completion | |
Other | The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Coding | Neuropsychological test assessing attention | Baseline, week 4 (i.e., after the last EPO injection and 8th ECT session), and 3 months after ECT treatment completion | |
Other | Verbal Fluency with the letter "D" | Neuropsychological test assessing executive functions | Baseline, week 4 (i.e., after the last EPO injection and 8th ECT session), and 3 months after ECT treatment completion | |
Other | Wechsler Adult Intelligence Scale (WAIS)-III Letter-Number Sequencing | Neuropsychological test assessing executive functions | Baseline, week 4 (i.e., after the last EPO injection and 8th ECT session), and 3 months after ECT treatment completion | |
Other | Trail Making Test Part B | Neuropsychological test assessing executive functions | Baseline, week 4 (i.e., after the last EPO injection and 8th ECT session), and 3 months after ECT treatment completion | |
Other | Rapid Visual Information Processing (RVP) from the Cambridge Neuropsychological Test Automated Battery (CANTAB Cognition Ltd.) | Neuropsychological test assessing sustained attention | Baseline, week 4 (i.e., after the last EPO injection and 8th ECT session), and 3 months after ECT treatment completion | |
Other | Hamilton Depression Rating Scale 17-items Version | Clinician-based interview assessing depression severity | Baseline, week 4 (i.e., after the last EPO injection and 8th ECT session), and 3 months after ECT treatment completion | |
Other | Beck Depression Inventory 21-items | Questionnaire assessing subjectively-rated depression severity | Baseline, week 4 (i.e., after the last EPO injection and 8th ECT session), and 3 months after ECT treatment completion | |
Other | Cognitive Complaints in Bipolar Disorder Rating Assessment | Questionnaire assessing subjectively-rated cognitive complaints | Baseline, week 4 (i.e., after the last EPO injection and 8th ECT session), and 3 months after ECT treatment completion | |
Primary | Cognitive composite score | A cognitive composite score based on an average of the Rey Auditory Verbal Learning Test (RAVLT), The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Coding, Verbal Fluency with the letter "D", Wechsler Adult Intelligence Scale (WAIS)-III Letter-Number Sequencing, Trail Making Test Part B, and Rapid Visual Information Processing (RVP) from the Cambridge Neuropsychological Test Automated Battery (CANTAB Cognition Ltd.). | Change from baseline to week 4 (i.e., after the last EPO injection and 8th ECT session) | |
Secondary | Autobiographical Memory Interview-Short Form (AMI-SF) | Neuropsychological test assessing retrograde autobiographical memory | Baseline, week 4 (i.e., after the last EPO injection and 8th ECT session), and 3 months after ECT treatment completion | |
Secondary | Rey Auditory Verbal Learning Test (RAVLT) | Neuropsychological test assessing verbal learning and memory | Baseline, week 4 (i.e., after the last EPO injection and 8th ECT session), and 3 months after ECT treatment completion |
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