Status:
COMPLETED
Effects of Erythropoietin on Cognition and Neural Activity in Mood Disorders
Lead Sponsor:
Lars Vedel Kessing
Collaborating Sponsors:
Mental Health Services in the Capital Region, Denmark
Lundbeck Foundation
Conditions:
Bipolar Disorder
Cognitive Impairment
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The present trial consists of 2 sub-studies that investigate important novel aspects of treatment with erythropoietin (EPO) on cognitive dysfunction in bipolar disorder (BD) and recurrent unipolar dep...
Detailed Description
This trial will include healthy people (sub-study 1) and patients with bipolar disorder or recurrent unipolar depressive disorder in partial or full remission (defined as a score of ≤14 on the Hamilto...
Eligibility Criteria
Inclusion
- Fluent Danish skills and objective cognitive impairment (a total score below cutoff, or scores below cutoff on a minimum of two out of the five subtests (Verbal Learning Test - Immediate, Working Memory Test, Verbal Fluency Test, Verbal Learning Test - Delayed and Processing Speed Test) on the Screen for Cognitive Impairment in Psychiatry - Danish version (SCIP-D).
- Patients must meet the ICD-10 diagnosis of BD (type I and II) or recurrent depressive disorder confirmed using the Schedules for Clinical Assessment in Neuropsychiatry (SCAN) interview.
- Healthy people are eligible even when diagnosed with a less severe mental disorder defined as ICD-10 codes ≥F40.
Exclusion
- Schizophrenia or schizoaffective disorder
- Current alcohol or substance misuse disorder (3 months prior to inclusion)
- Daily use of benzodiazepines \> 22.5 mg oxazepam
- Diabetes
- Kidney disease
- Renal failure
- Untreated/insufficiently treated arterial hypertension
- Heart diseases (previously diagnosed or abnormal ECG findings during screening)
- Previous serious head trauma
- Neurological illness (including dementia)
- 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
- Dyslexia
- Claustrophobia
- Having a pacemaker or other metal implants inside the body
- Reluctance or inability to comply with the protocol requirements
Key Trial Info
Start Date :
July 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT03315897
Start Date
July 5 2017
End Date
October 1 2022
Last Update
March 16 2023
Active Locations (1)
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1
Mental Health Services, Capital Region of Denmark, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, 2100