E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Unipolar/bipolar depression |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045543 |
E.1.2 | Term | Unipolar depression |
E.1.2 | System Organ Class | 100000004873 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004936 |
E.1.2 | Term | Bipolar depression |
E.1.2 | System Organ Class | 100000004873 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Main objective is to investigate whether short-term add-on treatment with high dose erythropoietin (EPO) can counteract the cognitive sideeffects of ECT and if such beneficial effects are long-lasting. |
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E.2.2 | Secondary objectives of the trial |
We wish to examine whether potential protective effects of EPO on cognition are accompanied by changes in markers of oxidative stress, inflammation and neuroplasticity in blood -Furthermore we will investigate the neural mechanisms for such beneficial effects on cognition using structural and functional magnetic resonance imaging (MRI) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome comprises change from baseline to post-treatment on a cognitive composite score assessing attention, verbal learning and memory, and executive functions. The following neuropsychological tests are included: 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 (TMT-B), and Rapid Visual Information Processing (RVP) from the Cambridge Neuropsychological Test Automated Battery (CANTAB Cognition Ltd.). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Primary endpoint is evaluated at baseline, week 4 (1-4 days after 8th ECT), and finally at week 18 (3-4 months after final ECT. |
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E.5.2 | Secondary end point(s) |
The secondary outcome includes a cognitive composite covering retrograde autobiographical memory measured with the Columbia University Autobiographical Memory Interview-Short Form (AMI-SF) and verbal learning and memory assessed with RAVLT |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Secondary endpoints are evaluated at baseline, week 4 (1-4 days after 8th ECT), and finally at week 18 (3-4 months after final ECT. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The last visit of the last subject undergoing the trial is 31st of December 2021 |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |