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    Summary
    EudraCT Number:2016-004023-24
    Sponsor's Protocol Code Number:PRETEC-EPO
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-10-24
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2016-004023-24
    A.3Full title of the trial
    Effect of erythropoietin (EPO) on cognitive function and frontal lobe activity in patients with bipolar disorder and unipolar depression in remission (PRETEC-EPO)
    Effekt af erythropoietin (EPO) på kognitiv funktion og frontallapsaktivitet hos patienter med bipolar lidelse eller unipolar depression i remission (PRETEC-EPO)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of erythropoietin (EPO) on memory and concentration difficulties and brain activity in people with previous (hypo)mania and/or depression
    Effekt af erythropoietin (EPO) på hukommelses- og
    koncentrationsbesvær og hjernefunktion hos personer med bipolar lidelse eller depression i stabil fase
    A.4.1Sponsor's protocol code numberPRETEC-EPO
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCopenhagen Affective Disorder research Center (CADIC), Psychiatric Centre Copenhagen, Rigshospitalet
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLundbeckfonden
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCopenhagen Affective Disorder research Center (CADIC), Psychiatric Centre Copenhagen, Rigshospitalet
    B.5.2Functional name of contact pointLars Vedel Kessing
    B.5.3 Address:
    B.5.3.1Street AddressEdel Sauntes Allé 10
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4538647081
    B.5.6E-maillars.vedel.kessing@regionh.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Eprex
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEprex
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNErythropoietin (EPO)
    D.3.9.1CAS number 11096-26-7
    D.3.9.3Other descriptive nameERYTHROPOIETIN
    D.3.9.4EV Substance CodeSUB13707MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40.000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeEPO is a glycoprotein hormone produced by recombinant DNA technology in mammalian cell culture
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bipolar disorder and unipolar depression
    E.1.1.1Medical condition in easily understood language
    Bipolar disorder (depression and mania) and depression
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10057667
    E.1.2Term Bipolar disorder
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10045543
    E.1.2Term Unipolar depression
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to investigate the effect of 12 weeks of erythropoietin (EPO) treatment on cognitive impairments in patients with bipolar disorder or depression in remission with cognitive difficulties
    E.2.2Secondary objectives of the trial
    The secondary objective is to investigate whether an early change in neural activity in prefrontal cortex correlates with and predicts improvements of cognitive functions in patients with bipolar disorder or depression in remission with cognitive difficulties
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with bipolar disorder or unipolar depression in remission:

    • Bipolar disorder or unipolar depression confirmed with Schedules for Clinical Assessment in Neuropsychiatry (SCAN)-interview
    • 18-65 years of age
    • Score <=14 on Hamilton Depression Rating Scale 17 items (HDRS-17) and Young Mania Rating Scale (YMRS)
    • Cognitive difficulties assessed with the Danish version of the Screen for Cognitive Impairment in Psychiatry (SCIP), defined as a summed score of <=77 or score below cutoff on at least 2/5 subtests (list learning <=21, consonant trigramme task <=18, verbal fluency <=14, delayed list recall <=6, and visuomotor task <=10) on the SCIP-D (Jensen et al., 2015; Purdon, 2005) at the time of inclusion. Cutoff-scores are determined for each subtest in Jensen et al. (2015).

    Participants must have adequate levels of Danish language skills to participate in the study.
    E.4Principal exclusion criteria
    Previous EPO-treatment
    Drug abuse or addiction (including alcohol and benzodiazepines corresponding to >22.5 mg. alopam per day)
    Kidney disease
    Diabetes
    Pregnancy or breast feeding
    Women, who use the contraceptive pill or other hormonal contraceptives (not including hormonal coil) and do not want to use hormonal coil, copper coil or double barrier anticontraceptive methods
    Sexually active women in the fertile age, who do not or do not want to use hormonal coil, copper coil or double barrier anticontraceptive methods
    Previous head trauma
    Neurological illness
    Smoking
    Heart diseases (previously diagnosed or abnormal EKG findings during screening)
    Previous or current epilepsy in the participants or his/her first degree family
    Previous or current tromboembolic events or tromboses in first degree family occured before the age of 60 (because of increased tromboembolic risk)
    Contraindications against profylactic trombosis treatment
    Myeloproliferative disorder, polycythemia
    Obesity (BMI > 30) or a body weight of <45 kg or >95 kg
    Major surgical treatment within 4 weeks before inclusion in the study
    Known allergy to or antibodies against EPO
    Previous or current cancer disease
    Untreated or insufficiently treated hypertension ("therapy resistant hypertension" defined as a blood pressure over 140/90 mmHg; mean of 3 measures with 2 minute interval morning/midday and evening for three days)
    Baseline hematocrit value >50% for men and >48% for women
    Thrombocyte numbers over normal (>400 billions/L)
    Reticulocyte numbers ERC(B), below 1*10^-3
    Reluctance or inability to comply with the protocol requirements, including the presence of any condition (physical, mental or social), which is likely to affect the participant's ability to comply with the protocol
    Current somatic disease, which is evaluated as being of importance for patient participation
    Electroconvulsive (ECT) treatment within the last 3 months
    Dyslexia
    Claustrophobia
    Pacemaker or metal implantate in the body
    Insufficient Danish language skills
    E.5 End points
    E.5.1Primary end point(s)
    Difference in the change of:

    (i) A collected measure of cognition (a composite score) encompassing the following measures: Rey Auditory Verbal Learning Test – Total Recall (RAVLT; Schmidt, 2004), the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Coding (Randolph, 1998), verbal fluency (with letter "D"; Borkowski, Benton, & Spreen, 1967), WAIS-III Letter-Number Sequencing (Wechsler, 1997), Trail Making Test Part B (TMT-B; Army Individual Test Battery, 1944), and Rapid Visual Processing (RVP) from Cambridge Neuropsychological Test Automated Battery (CANTAB), which cover attention, verbal learning and memory, and executive functions.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary end points will be evaluated at baseline (week 1), week 3 (2 weeks after treatment initiation), week 13 (1 week after treatment ending), and at 6 months follow-up
    E.5.2Secondary end point(s)
    Difference in the change of:

    (i) Cognition (attention and processing speed) measured with Rapid Visual Processing (RVP; CANTAB)

    (ii) Function and quality of life measured with: the Functional Assessment Short Test (FAST; Rosa et al 2007)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary end points will be evaluated at baseline (week 1), week 3 (2 weeks after treatment initiation), week 13 (1 week after treatment ending), and at 6 months follow-up
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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 study will be completed by the end of juli 2022 (7-31-22)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 75
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state75
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 75
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Treatment as usual if necessary
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-12-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-07-06
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