Back to Search
Start Over
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.
- Source :
-
Trials . 11/6/2018, Vol. 19 Issue 1, pN.PAG-N.PAG. 1p. 1 Chart. - Publication Year :
- 2018
-
Abstract
- <bold>Background: </bold>Bipolar 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.<bold>Methods: </bold>The 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.<bold>Discussion: </bold>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.<bold>Trial Registration: </bold>ClinicalTrials.gov , NCT03315897. Registered on 20 October 2017. [ABSTRACT FROM AUTHOR]
- Subjects :
- *BIPOLAR disorder
*RECOMBINANT erythropoietin
*COGNITION
*AFFECTIVE disorders
*RANDOMIZED controlled trials
*ERYTHROPOIETIN
*RECOMBINANT proteins
*CLINICAL trials
*MENTAL depression
*EXPERIMENTAL design
*FAMILIES
*MAGNETIC resonance imaging
*HEALTH outcome assessment
*RESEARCH funding
*SAMPLE size (Statistics)
*BLIND experiment
*EXECUTIVE function
*THERAPEUTICS
Subjects
Details
- Language :
- English
- ISSN :
- 17456215
- Volume :
- 19
- Issue :
- 1
- Database :
- Academic Search Index
- Journal :
- Trials
- Publication Type :
- Academic Journal
- Accession number :
- 132863912
- Full Text :
- https://doi.org/10.1186/s13063-018-2995-7