The effects of erythropoietin on depressive symptoms and neurocognitive deficits inpatients with treatment resistant depression and in patients with remitted bipolar disorder – a proof of concept study

Phase 1

• Conditions: Treatment resistant depression and bipolar disorder in remission.; MedDRA version: 9.1Level: LLTClassification code 10050648Term: Blood erythropoietin

• Registration Number: EUCTR2008-004857-14-DK
• Lead Sponsor: Psykiatrisk Center Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-16
• Study Completion: 2012-10-31
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Sub-study 1:
Treatment resistant depression, age 18-65 years, Hamilton Depression Scale 17 items (HAMD-17) (Hamilton 1960) score > 17. Treatment resistance is defined by lack of response to at least two different types of antidepressants. Patients are required to not make any changes in their antidepressant medication for at least 2 weeks prior to or during the study.

Sub-study 2:
Patients with remitted bipolar disorder, age 18-65 years, HAMD-17 score < 14 and a Young Mania Scale (YMS) score < 14, who have subjective complaints about cognitive problems in a moderate to severe degree in at least 2 of 7 cognitive categories on the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (Fava et al 2006) (score > 4 in these domains).
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria are any significant medical conditions (incl. diabetes, epilepsy, hypertension and thrombosis), pregnancy, smoking, current medication (incl. the contraceptive pill), or first-degree family history of blood clotting, heart disease, seizure disorders or pregnancy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified