Validation of the predictive value of BDNF -87 methylation for antidepressant treatment success in severely depressed patients-a randomized rater-blinded trial.

BACKGROUND: Brain-derived neurotrophic factor (BDNF) is essential for antidepressant treatment of major depressive disorder (MDD). Our repeated studies suggest that DNA methylation of a specific CpG site in the promoter region of exon IV of the BDNF gene (CpG -87) might be predictive of the efficacy of monoaminergic antidepressants such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and others. This trial aims to evaluate whether knowing the biomarker is non-inferior to treatment-as-usual (TAU) regarding remission rates while exhibiting significantly fewer adverse events (AE). METHODS: The BDNF trial is a prospective, randomized, rater-blinded diagnostic study conducted at five university hospitals in Germany. The study's main hypothesis is that {1} knowing the methylation status of CpG -87 is non-inferior to not knowing it with respect to the remission rate while it significantly reduces the AE rate in patients experiencing at least one AE. The baseline assessment will occur upon hospitalization and a follow-up assessment on day 49 (± 3). A telephone follow-up will be conducted on day 70 (± 3). A total of 256 patients will be recruited, and methylation will be evaluated in all participants. They will be randomly assigned to either the marker or the TAU group. In the marker group, the methylation results will be shared with both the patient and their treating physician. In the TAU group, neither the patients nor their treating physicians will receive the marker status. The primary endpoints include the rate of patients achieving remission on day 49 (± 3), defined as a score of ≤ 10 on the Hamilton Depression Rating Scale (HDRS-24), and the occurrence of AE. ETHICS AND DISSEMINATION: The trial protocol has received approval from the Institutional Review Boards at the five participating universities. This trial holds significance in generating valuable data on a predictive biomarker for antidepressant treatment in patients with MDD. The findings will be shared with study participants, disseminated through professional society meetings, and published in peer-reviewed journals. TRIAL REGISTRATION: German Clinical Trial Register DRKS00032503. Registered on 17 August 2023.

Assessment of cognitive functioning after living kidney donation: A cross-sectional pilot study.

BACKGROUND: Chronic kidney disease (CKD) has emerged as a risk factor for cognitive impairment. Living kidney donation results in reduction of the donors' renal function. This is considered acceptable in general but possible associations with cognitive function have not yet been studied. METHODS: Sixty living kidney donors (LKD), who had donated between 2003 and 2012 at Hannover Medical School, underwent neurocognitive testing including attentional and memory testing. In a cross-sectional design results were compared with data of healthy controls (n = 40) and with norm data given in the respective test manuals adjusted for age, sex, and education. RESULTS: The median age of the LKD was 58 (range 39-70) years and the median time since donation was 7 (range 4-14) years. The LKD did not differ from controls in most of the cognitive test results and a composite attention test sum score. However, LKD did worse than controls in tests of working memory, parallel processing of stimuli, and sustained attention. No differences were found regarding quality of life. In LKD cognitive test results correlated significantly only with educational level but not with time since transplantation, eGFR, somatic comorbidity, quality of life and levels of fatigue, distress, depression, and anxiety. CONCLUSIONS: Our data show a fairly normal performance of LKD in most attentional and memory tests. However, our pilot study also suggests some cognitive impairment in attention tests in LKD which would need to be confirmed in longitudinal prospective studies.

Partnership Satisfaction in Living Kidney Donors.

Due to organ shortage, living kidney donation is gaining increasing importance. Medical progress enables a successful transplantation between unrelated individuals, even individuals with AB0-incompatibilities. Spouses are the largest group of living kidney donors. The aim of this study was to assess partnership status and partnership satisfaction in living kidney donors. In the cross-sectional study we investigated 361 living kidney donors. The time since donation ranged between 1 and 38 years. The partnership satisfaction was assessed with the German version of the Quality of Marriage Index. We compared the donor sample with a representative German population sample (n = 1995). In addition, we compared donors who have donated to their partner (spouse donors) to those who have donated to someone else (non-spouse donors). In comparison to the population sample significantly more kidney donors were living in a relationship (82 vs. 60%). Most donors reported an unchanged (76.6%) or improved (20.5%) relationship to the recipient since transplantation. A significantly higher partnership satisfaction could be found in the donor sample compared to the population sample which was mainly due to a higher partnership satisfaction of the spouse donors compared to the non-spouse donors. High partnership satisfaction in living kidney donors might be an indicator for a successful selection process before transplantation. Alternatively, kidney donation might have a stabilizing or even positive impact on the partnership. Due to the design of our study causative interpretations cannot be made. Therefore, prospective studies are required to assess partnership satisfaction before and after living kidney donation.

[Negative Effects of Psychotherapy: Prevalence and Correlates in a Clinical Sample]. / Negative Effekte von Psychotherapie: Häufigkeit und Korrelate in einer klinischen Stichprobe.

INTRODUCTION: So far, the prevalence of negative effects of psychotherapy and their correlates have rarely been investigated in a systematic manner. The prevalence of negative effects varied between 3 studies with the Inventory for Assessing Negative Effects of Psychotherapy (INEP) with 20, 84, and 93.8% substantially. Thereby, the impact of bias effects remains unclear. In addition, reported correlates of the number of negative effects were examined and augmented with further correlates. MATERIAL AND METHODS: For the study, a clinical sample of inpatients and day-patients (N=200) evaluated their previous psychotherapy retrospectively before their current admission with the Inventory for Assessing Negative Effects of Psychotherapy (INEP). Sociodemographic and clinical data of both patients and therapists as well as time-related and methodical aspects of the evaluated psychotherapy were examined as possible correlates. RESULTS: 70.5% (n=141) of the patients reported at least one negative effect (M=2.11, SD=2.23). The most common negative effects were "longer periods of negative mood" (39.9%) and "being offended by statements of the therapist" (28%). Higher symptom severity, lower subjective success of the evaluated therapy, as well as unfulfilled expectations regarding therapy outcome but not the quality of the therapeutic relationship were associated with a higher number of negative effects. Also female gender of patient and therapist and a younger age of the therapist were significantly associated with more negative therapy effects. CONCLUSION: The prevalence of negative effects was not negligible. In line with previous studies, the highest rates of negative effects were reported for "symptoms" and aspects of the "therapeutic relationship". The study confirms several correlates for the number of retrospectively assessed negative effects. Patients need to be informed about negative effects prior to psychotherapeutic treatment.

Adaptive Personality Traits and Psychosocial Correlates among Living Kidney Donors.

Since living kidney donors have repeatedly been shown to be mentally more healthy compared to the general population, they might also exhibit more adaptive personality characteristics. We investigated the personality traits of 315 living kidney donors (202 female and 113 male donors) on average 7.1 years after donation using the NEO-Five Factor Inventory, a frequently used personality inventory measuring the "big five" dimensions of personality (neuroticism, extraversion, openness, agreeableness, and conscientiousness). In addition, levels of depression, anxiety, and fatigue were assessed with the Patient Health Questionnaire-Depression Scale, GAD-7, and Multidimensional Fatigue Inventory. Kidney donors showed more adaptive personality traits with higher agreeableness and lower neuroticism scores compared to the German general population. This was even more pronounced in living kidney donors with a high motivation to donate again (non-regreters). Scores for depression, anxiety, and fatigue did not differ from general population values and were significantly correlated with most personality dimensions. The more adaptive personality characteristics of living kidney donors might either be a selection effect or the consequence of the experience of donation and improved health of the close relative. Regardless of the causal relationship, adaptive personality traits might positively influence both physical and psychosocial well-being of the donor. Longitudinal studies should investigate if living donation might lead to persistent adaptive changes in personality traits.