Treatment resistant depression and bipolar disorder in remission. MedDRA version: 9.1 Level: LLT Classification code 10050648 Term: Blood erythropoietin
Conditions
Interventions
Trade Name: Eprex
Pharmaceutical Form: Injection*
INN or Proposed INN: Erythropoietin
CAS Number: 113427-24-0
Current Sponsor code: 8119
Other descriptive name: Epo
Concentration unit: IU internationa
Sponsors
Psykiatrisk Center Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
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 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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to investigate (1) whether repeated administration of Erythropoietin (Epo) is able to improve mood and reverse neurocognitive dysfunction in patients with treatment resistant depression and (2) whether repeated Epo administration can normalize pervasive neurocognitive deficits seen in patients with remitted unipolar and bipolar illness.;Secondary Objective: We wish to investigate effects of Epo on the following biomarkers for potential treatment response: (1) Neural underpinnings of cognitive function. (2) Peripheral BDNF and inflammatory markers. (3) Metabolism ;Primary end point(s): Sub-study 1: Antidepressant effect as reflected by a clinically significant improvement in the Hamilton Depression Scale 17 items (HAMD-17) scores in patients given Epo vs. placebo (min. 3 points difference between groups). Sub-study 2: Improvement of memory as reflected by a clinically significant improvement of performance on the Rey Auditory Verbal Learning Test (RAVLT) in patients given Epo vs. placebo (min. 4 scores difference between groups). | — |
Countries
Denmark
Outcome results
None listed