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Completed

NCT Number: NCT00916552

Effects of Erythropoietin on Depressive Symptoms and Neurocognitive Deficits in Depression and Bipolar Disorder

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 memory, attention and planning problems. There is thus a need for better, more efficient treatments with effects on cognitive function. Erythropoietin (Epo) is involved in brain repair and may be a candidate for future treatment strategies. The investigators have demonstrated that a single dose of Epo improves mood and reduces the processing of negative emotional information in healthy volunteers similar to effects seen with antidepressants. With the current study the investigators aim to build upon this discovery by investigating whether repeated Epo administration has antidepressant effects and is able to reverse cognitive difficulties in patients with depression or bipolar disorder. It is hypothesized that Epo will improve mood in treatment-resistant depression and improve cognitive function in this group and in patients with bipolar disorder in remission. If the study reveals beneficial effects of Epo, this would highlight Epo as a candidate compound for future treatment of depression and bipolar disorder, with the potential to directly promote brain repair mechanisms.

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Key information

Conditions

Mood Disorders Behavior Behavioral Symptoms Bipolar Disorder Bipolar and Related Disorders Depression Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Copenhagen University Hospital, Rigshospitalet

Copenhagen, 2200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Erythropoietin

Drug

40.000 IU/ml epoetin alfa is administered as intravenous infusions over 15 min weekly for 8 weeks.

Other names: Eprex, Epo

Primary outcomes

  1. a) For treatment-resistant depressed patients: Antidepressant effect measured with the Hamilton Depression Rating Scale (HDRS); b) For bipolar patients in remission: Memory measured with the Rey Auditory Verbal Memory Test.

    Time frame: a) Baseline and weeks 5, 9 and 14; b) Baseline and weeks 9 and 14

Secondary outcomes

  1. a) For treatment-resistant depressed patients: number of remissions measured with the HDRS; b) For bipolar patients in remission: sustained attention measured with the RVIP and facial expression recognition.

    Time frame: a) Baseline and weeks 5, 9 and 14; b) Baseline and weeks 9 and 14

Sponsors and collaborators

Lead sponsor

Lars Vedel Kessing, professor, MD, DMSc.

Other

Collaborators

  • Max-Planck-Institute of Experimental Medicine
  • Novo Nordisk A/S
  • The Ministry of Science, Technology and Innovation, Denmark
  • University of Oxford

Registry information

Official study title

The Effects of Erythropoietin on Depressive Symptoms and Neurocognitive Deficits in Patients With Treatment Resistant Depression and in Patients With Remitted Bipolar Disorder - a Proof of Concept Study

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 9, 2009
Registry last updated
Nov 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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