E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment resistant depression and bipolar disorder in remission. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050648 |
E.1.2 | Term | Blood erythropoietin |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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). |
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | 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). |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The last visit of the last subject undergoing the trial: 30th August 2013. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |