Evidence map›Paper›PMID 30400939›Full record

ArticleTrials2018

Effects of recombinant human erythropoietin on cognition and neural activity in remitted patients with mood disorders and first-degree relatives of patients with psychiatric disorders: a study protocol for a randomized controlled trial.

Jeff Zarp Petersen, Lejla Sjanic Schmidt, Maj Vinberg, Martin Balslev Jørgensen, Ida Hageman, Hannelore Ehrenreich, Gitte Moos Knudsen, Lars Vedel Kessing, Kamilla Woznica Miskowiak

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03315897 (Effects of Erythropoietin on Cognitive Functions and Neural Activity in Cognitively Impaired Remitted Patients With Bipolar Disorder or Recurrent Depressive Disorder and Healthy People), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.1field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03315897 phase2completednot on this map

Effects of Erythropoietin on Cognitive Functions and Neural Activity in Cognitively Impaired Remitted Patients With Bipolar Disorder or Recurrent Depressive Disorder and Healthy People: Study Protocol for a Randomized, Controlled Trial

TypeinterventionalSponsorLars Vedel KessingRan2017 to 2022Enrolled103ConditionsBipolar Disorder, Cognitive Impairment, Unipolar DepressionArmsErythropoietin, Saline
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 28 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 2 countries.

Jeff Zarp PetersenNeurocognition and Emotion in Affective Disorder (NEAD) Group, Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.
Lejla Sjanic SchmidtNeurocognition and Emotion in Affective Disorder (NEAD) Group, Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.
Maj VinbergNeurocognition and Emotion in Affective Disorder (NEAD) Group, Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.
Martin Balslev JørgensenNeurocognition and Emotion in Affective Disorder (NEAD) Group, Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.
Ida HagemanNeurocognition and Emotion in Affective Disorder (NEAD) Group, Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.
Hannelore EhrenreichClinical Neuroscience, Max Planck Institute of Experimental Medicine, Göttingen, Germany.
Gitte Moos KnudsenNeurobiology Research Unit and Center for Integrated Molecular Imaging, Rigshospitalet, Copenhagen, Denmark.
Lars Vedel KessingNeurocognition and Emotion in Affective Disorder (NEAD) Group, Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.
Kamilla Woznica MiskowiakNeurocognition and Emotion in Affective Disorder (NEAD) Group, Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital, Blegdamsvej 9, DK-2100, Copenhagen, Denmark. kamilla.woznica.miskowiak@regionh.dk.
University of Copenhagen · DKCopenhagen University Hospital · DKMax Planck Institute of Experimental Medicine · DE

Funding

Lundbeckfonden (DK) R21520154121
6 · The paper itself

Abstract

backgroundBipolar disorder (BD) and unipolar disorder (UD) are associated with cognitive deficits and abnormal neural activity in a "cognitive control network." There is an increased prevalence of cognitive dysfunction in psychiatric patients' first-degree relatives, which constitutes a risk factor for psychiatric illness onset. However, there is no treatment with enduring pro-cognitive efficacy. We found preliminary evidence for beneficial effects of eight weekly doses of recombinant human erythropoietin (EPO) on cognition in BD in a recent randomized controlled trial (RCT). The present RCT consists of two sub-studies that extend our previous work by investigating important novel aspects: (1) the effects of 12 weekly doses of EPO on cognition in first-degree relatives of patients with BD, UD, or schizophrenia; and (2) the effects of extending the treatment schedule from 8 to 12 weeks in remitted patients with BD or UD; and (3) assessment of early treatment-associated neural activity changes that may predict cognitive improvement.

methodsThe trial comprises two parallel sub-studies with randomized, controlled, double-blinded, parallel group designs. First-degree relatives (sub-study 1; n = 52) and partially or fully remitted patients with BD or UD (sub-study 2; n = 52) with objectively verified cognitive dysfunction are randomized to receive weekly high-dose EPO (40,000 IU/mL) or placebo (saline) infusions for 12 weeks. Assessments of cognition and mood are conducted at baseline, after two weeks of treatment, after treatment completion, and at six-month follow-up. Functional magnetic resonance imaging (fMRI) is conducted at baseline and after two weeks of treatment. Psychosocial function is assessed at baseline, after treatment completion and six-month follow-up. The primary outcome is change in a cognitive composite score of attention, verbal memory, and executive functions. Statistical power of ≥ 80% is reached to detect a clinically relevant between-group difference by including 52 first-degree relatives and 52 patients with BD or UD, respectively. Behavioral data are analyzed with an intention-to-treat approach using mixed models. fMRI data are analyzed with the FMRIB Software Library. DISCUSSION: If this trial reveals pro-cognitive effects of EPO, this may influence future treatment of mood disorders and/or preventive strategies in at-risk populations. The fMRI analyses may unravel key neurobiological targets for pro-cognitive treatment.

trial registrationClinicalTrials.gov , NCT03315897. Registered on 20 October 2017.

Indexed as

Randomized Controlled Trials as TopicAdolescentAdultAgedBipolar DisorderCognitionDepressive DisorderDouble-Blind MethodErythropoietinExecutive FunctionFamilyHumansMagnetic Resonance ImagingMiddle AgedMood DisordersOutcome Assessment, Health CareErythropoietinRecombinant ProteinsBiomarkerBipolar disorderCognitionCognitive dysfunctionDepressionErythropoietinFunctional magnetic resonance imagingPrefrontal cortexPro-cognitive efficacy

Identifiers

PMID30400939
PMCPMC6220567
OpenAlexW2900075980

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.