Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Lars Vedel Kessing, professor, MD, DMSc.
With
The Ministry of Science, Technology and Innovation, Denmark
Novo Nordisk A/S
University of Oxford
Max-Planck-Institute of Experimental Medicine
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Treatment-resistant depression (defined as failure to respond to at least 2 different types of antidepressants) and an HDRS score of at least 17
OR
Bipolar disorder in remission (HDRS score of max 14 and Young Mania Scale score of max 14) and subjective complaints of moderate to severe cognitive problems on the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) (Fava et al 2006) (score at least 4 on at least 2 domains)
Unchanged antidepressant or mood stabilizing treatment for at least 2 weeks prior to and during the study
You may not be if
Schizophrenia/ schizoaffective disorder
Dependence on or abuse of drugs (including alcohol and benzodiazepines corresponding to more than 22.5 mg Oxazepam daily)
Diabetes
Renal failure
Smoking
Major surgery within 4 weeks prior to inclusion
Previous Epo-treatment
Known allergy or antibodies against Epo
Present or past malignancies
Epilepsy or epilepsy in first degree family Diagnosis (past or present) of a cardiovascular or cerebrovascular disease
Untreated or not sufficiently treated arterial hypertension ("therapy-resistant hypertension")
Initial hematocrit \> 50% (males) or \> 48% (females)
Initial platelet count above normal range of laboratory
Initial reticulocyte count below norma range of laboratory
Past thromboembolic events or thromboembolic events in first degree family (increased thromboembolic risk)
Contraindications against prophylactic thrombosis treatment
Myeloproliferative disorder, polycythemia
Present immunosuppressive treatment with cyclosporin
Overweight (BMI \> 30) or body weight of less than 45 kg or over 95 kg
Acute suicidal risk, present or previous suicide attempts in the past 2 years
Pregnancy or breast feeding
Women who presently use contraceptive pills
Sexually active women with child bearing potential who refuse to use double barrier anticonception methods
Unwillingness or inability to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol
Present illness which in investigator's opinion could affect the patient's participation in the study
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