Status:
COMPLETED
Effects of Erythropoietin on Depressive Symptoms and Neurocognitive Deficits in Depression and Bipolar Disorder
Lead Sponsor:
Lars Vedel Kessing, professor, MD, DMSc.
Collaborating Sponsors:
The Ministry of Science, Technology and Innovation, Denmark
Novo Nordisk A/S
Conditions:
Mood Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Depression and bipolar disorder (mania and depression) may be related to problems with nerve cells not being regenerated as fast as normal and are accompanied by cognitive difficulties including memor...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00916552
Start Date
September 1 2009
End Date
October 1 2012
Last Update
November 9 2012
Active Locations (1)
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1
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, 2200