![]() These deficits are not only present during acute episodes, but commonly persist after remission. Registered on 20 October 2017.Ĭognitive deficits occur in moderate to severe degree in patients with bipolar disorder (BD) and unipolar disorder (UD). The fMRI analyses may unravel key neurobiological targets for pro-cognitive treatment. #Autumn 8 software icd indicator trial#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. #Autumn 8 software icd indicator software#fMRI data are analyzed with the FMRIB Software Library. Behavioral data are analyzed with an intention-to-treat approach using mixed models. 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. The primary outcome is change in a cognitive composite score of attention, verbal memory, and executive functions. Psychosocial function is assessed at baseline, after treatment completion and six-month follow-up. Functional magnetic resonance imaging (fMRI) is conducted at baseline and after two weeks of treatment. ![]() Assessments of cognition and mood are conducted at baseline, after two weeks of treatment, after treatment completion, and at six-month follow-up. 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. The trial comprises two parallel sub-studies with randomized, controlled, double-blinded, parallel group designs. ![]() 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. 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). However, there is no treatment with enduring pro-cognitive efficacy. 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. ![]()
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