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

November 8, 2012 updated by: Lars Vedel Kessing, professor, MD, DMSc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2200
        • Copenhagen University Hospital, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erythropoeitin
40.000 IU, epoetin alfa; Janssen-Cilag
Drug: Erythropoietin
40.000 IU/ml epoetin alfa is administered as intravenous infusions over 15 min weekly for 8 weeks.
Other Names:
  • Eprex
  • Epo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
a) Baseline and weeks 5, 9 and 14; b) Baseline and weeks 9 and 14

Secondary Outcome Measures

Outcome Measure
Time Frame
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
a) Baseline and weeks 5, 9 and 14; b) Baseline and weeks 9 and 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lars Vedel Kessing, professor, MD, DMSc.

Collaborators

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

Investigators

  • Principal Investigator: Lars V Kessing, Professor, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

June 8, 2009

First Submitted That Met QC Criteria

June 8, 2009

First Posted (Estimate)

June 9, 2009

Study Record Updates

Last Update Posted (Estimate)

November 9, 2012

Last Update Submitted That Met QC Criteria

November 8, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPO1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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