Unipolar/bipolar depression MedDRA version: 21.1 Level: LLT Classification code 10045543 Term: Unipolar depression System Organ Class: 100000004873 MedDRA version: 21.1 Level: LLT Classification code 10004936 Term: Bipolar depression System Organ Class: 100000004873
Conditions
Interventions
Trade Name: Eprex
Product Name: Eprex
Pharmaceutical Form: Infusion
INN or Proposed INN: Erythropoietin (EPO)
CAS Number: 11096-26-7
Other descriptive name: ERYTHROPOIETIN
Concentration unit: IU inter
Sponsors
Region Hovedstadens psykiatriske hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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);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.). ;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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 ;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. | — |
Countries
Denmark
Outcome results
None listed