Introduction: Non-suicidal self-injury (NSSI), which refers to the deliberate act of causing harm to one's own body without the intent to commit suicide, occurs in 20% of youth. Interestingly, approximately 90% of individuals who engage in self-harm report intrusive mental imagery thereof shortly prior to the act of NSSI. Previous research has demonstrated that imagery rescripting (IR) is an effective technique to treat intrusive mental images and associated clinical symptoms, such as emotion dysregulation, in various psychiatric disorders. However, there is no research on IR for adolescents who self-harm. Therefore, the present study aims to investigate the efficacy and feasibility of a two-session short-intervention using IR to reduce NSSI and associated clinical symptoms in adolescents. The intervention was supported by an app-based digital health intervention (DHI). Methods: A single case series A-B design with three post-assessments (1 week, 1 month, and 3 months post-intervention) was implemented. Seven adolescents received two treatment sessions of IR, supported by a DHI between sessions. NSSI (SITBI), emotion regulation (ERQ), emotional distress (BDI-II, STAI-T), self-efficacy (WIRKALL_r), and treatment satisfaction (BIKEP) were evaluated. Results: There was an increase in adaptive emotion regulation strategies up to 3 months post-intervention. Furthermore, patients improved regarding their self-efficacy, depressiveness, anxiety, and NSSI symptomatology. The developed DHI was described as a helpful and supportive tool. Conclusion: The intervention has shown initial evidence to be feasible and beneficial for adolescents conducting NSSI. The DHI has demonstrated to be a valuable tool in the treatment of self-harming youth.
Studies on Emotionally Dysregulated Behavior (EDB) demonstrated that the conduct thereof is associated with emotion dysregulation and preceded by mental imagery of EDB, which can direct future behavior. These findings are specifically important within the context of Borderline Personality Disorder (BPD), where emotion dysregulation and EDB are at the core of the disorder. The present study aims to evaluate the efficacy of imagery rescripting (IR) in treating emotion dysregulation associated with EDB in patients diagnosed with BPD. Forty-eight females diagnosed with BPD were randomly allocated to the IR intervention or treatment-as-usual group. Assessment took place one week before the first treatment session, as well as one week, and twelve weeks after the last treatment session evaluating emotion regulation strategies, borderline-symptomatology, EDB, depressiveness, impulsivity, mental imagery, and illness severity. Within-, and between subject, intention-to-treat-, and per-protocol analysis were conducted. Results showed decreased maladaptive emotion regulation strategies and increased adaptive emotion regulation strategies within the intervention group. Borderline-symptomatology improved immediately after treatment for the intervention group. Additionally, BPD patients within the intervention group improved regarding their impulsivity, depressiveness, and EDB symptomatology in comparison to patients in the TAU group. The presented intervention has proven to be effective in improving BPD-related symptomatology, such as emotion regulation, EDB, depressiveness, and impulsivity. Imagery rescripting could be routinely applied when EDB related images are present. TRIAL REGISTRATION: German Clinical Trials Registry (DRKS) ID: DRKS00010620.
Borderline Personality Disorder , Female , Humans , Borderline Personality Disorder/therapy , Borderline Personality Disorder/psychology , Impulsive Behavior , Emotions/physiology
Relationship dysfunction-marked by frequent conflicts-is one of the hallmark features of borderline personality disorder (BPD). However, the BPD couple as a dyad and partner-related features have rarely been taken into account. The aim of the present study was to investigate hormonal, personality, and relationship relevant factors, such as relationship satisfaction, attachment, and trauma in both partners within a dyad where one partner is diagnosed with BPD. The total sample consisted of 26 heterosexual couples. All studies were conducted at 2 p.m. Primary outcomes: Neo-Five-Factor-Inventory, Childhood Trauma Questionnaire, Experiences in Close Relationships Scale. Secondary outcomes: Problem List, Partnership Questionnaire, Questionnaire for Assessing Dyadic Coping. Upon questionnaire completion, one saliva sample was taken via passive drool to assess baseline cortisol and testosterone levels. Results showed that females with BPD have higher scores on childhood maltreatment, dysfunctional attachment styles, and neuroticism than mentally healthy females. Furthermore, they have more relationship-related problems and are less satisfied in their romantic relationship. Male partners of women with BPD showed lower testosterone levels, higher levels of childhood maltreatment, dysfunctional attachment styles, neuroticism, and openness compared with the healthy control partners. Furthermore, childhood trauma, neuroticism as well as dysfunctional attachment styles displayed a significant positive correlation with relationship-related problems. Traumatic childhood experiences, insecure attachment styles as well as neurotic personality characteristics contribute to increased relationship disruptions in couples. Relevant hormonal and psychosocial parameters in BPD partners should be taken into account when treating females with BPD.
BACKGROUND: Drug-associated liver injury is one of the most common causes for acute liver failure and market withdrawal of approved drugs. In addition, the potential for hepatotoxicity related to specific substances has to be considered in psychopharmacotherapy. However, systematic evaluations of hepatotoxicity related to antipsychotics are limited. METHODS: We conducted an exploratory case/non-case study and evaluated pharmacovigilance data from VigiBase related to 30 antipsychotics marketed in the European Union. Reporting odds ratios were calculated for antipsychotics associated with the Standardized Medical Dictionary of Regulatory Activities queries "Drug-related hepatic disorders-comprehensive search" (DRHD-CS) and "Drug-related hepatic disorders-severe events only" (DRHD-SEO). RESULTS: We found several signals for drug-associated liver injury including signals for severe events: 17 of 30 antipsychotics were associated with DRHD-CS and 10 of 30 antipsychotics with DRHD-SEO. Amisulpride, fluphenazine, levomepromazine, loxapine, olanzapine, perazine, perphenazine, pipamperone, sulpiride, and thioridazine were associated with both, DRHD-CS and DRHD-SEO. No association with fatal outcomes was detected. CONCLUSIONS: Several common antipsychotics are associated with hepatotoxicity, partly also with severe hepatotoxicity. Our data do not allow to account for patient-related risk factors for drug-associated liver injury. This should be addressed in further studies.
Antipsychotic Agents , Chemical and Drug Induced Liver Injury , Amisulpride , Antipsychotic Agents/adverse effects , Chemical and Drug Induced Liver Injury/epidemiology , Chemical and Drug Induced Liver Injury/etiology , Humans , Pharmacovigilance
Background: The COVID-19 pandemic has imposed enormous psychological discomfort and fear across the globe, including Germany. Objectives: To assess the levels of COVID-19 associated psychological distress and fear amongst Southern German population, and to identify their coping strategies. Methods: A cross-sectional survey using an online questionnaire was conducted in healthcare and community settings in the region of Ulm, Southern Germany. Assessment inventories were the Kessler Psychological Distress Scale (K-10), the Brief Resilient Coping Scale (BRCS), and the Fear of COVID-19 Scale (FCV-19S), which were valid and reliable tools. Results: A total of 474 Individuals participated in the study. The mean age was 33.6 years, and 327 (69%) were females. Most participants (n = 381, 80.4%) had high levels of psychological distress, whereas only 5.1% had high levels of fear, and two-thirds of participants showed higher levels of coping. Moderate to very high levels of psychological distress were associated with being female, living alone, distress due to employment changes, experiencing financial impact, having multiple co-morbidities, being a smoker, increased alcohol use over the previous 6 months, contact with COVID-19 cases and healthcare providers for COVID-19-related stress. Individuals who were ≥60 years, lived with non-family members, had co-morbidities and visited a healthcare provider had higher levels of fear. Higher levels of education and income showed better coping amongst participants. Conclusion: Psychological distress was very high during the COVID-19 pandemic in Germany and associated with low levels of coping. This study identified vulnerable groups of people, who should be given priorities for addressing their health and wellbeing in future crisis periods.
PURPOSE: In aut-idem or generic substitution, discrepancies between summaries of product characteristics (SmPCs) referring to the same active substance (AS) may cause difficulties regarding informed consent and medical liability. The qualitative and quantitative characteristics of such discrepancies are insufficiently studied, impeding harmonization of same-substance SmPCs and compromising safe drug treatment. METHODS: SmPCs of the one hundred most frequently prescribed ASs in Germany were analyzed for discrepancies in the presentation of indications (Inds) and contraindications (CInds). Inclusion and exclusion criteria of drugs/SmPCs were chosen according to the standards of the aut-idem substitution in Germany. RESULTS: According to the study protocol, we identified 1486 drugs, of which 1426 SmPCs could be obtained. 41% respectively 65% of the ASs had same-substance SmPCs that differed from the respective reference SmPC in the number of listed Inds respectively CInds. The number of listed Inds/CInds varied considerably between same-substance SmPCs with maximum ranges in Inds of 7 in amoxicillin, and in CInds of 11 in lisinopril. Many ASs had large proportions (> 50%) of associated same-substance SmPCs that differed from the respective reference SmPC. A considerable proportion of ASs had same-substance SmPCs with formal and content-related differences other than the discrepancy in the number of Inds/CInds. CONCLUSION: This evaluation of same-substance SmPCs shows a clear lack of harmonization of same-substance SmPCs. Considering that generic substitution has become the rule and that physicians usually do not know which drug the patient receives in the pharmacy, these discrepancies raise several questions, that require a separate legal evaluation.
Drug Labeling/standards , Drugs, Generic/standards , Germany , Humans
Background and Objectives: A substantial portion of students report test anxiety, and those reporting low levels of self-efficacy seem to be especially affected. Previous research has indicated the relevance of mental images in the maintenance of anxiety disorders, however, no data are available with respect to test anxiety. In order to close this gap, the present study investigates the association between test anxiety, self-efficacy and mental images. Method: One hundred sixty-three university students completed an online survey. Test anxiety (PAF), general self-efficacy (WIRKALL-r), study-related self-efficacy (WIRK_STUD), intrusiveness of mental images (IFES), spontaneous use of imagery (SUIS) and vividness of imagery (VVIQ) were examined. Results: Test-related mental images were frequently reported among the surveyed students. Test anxiety showed a positive correlation with IFES and a negative correlation with self-efficacy. Mediation analyses showed that about one fifth of the influence of self-efficacy on test anxiety is mediated by IFES. Discussion: The present study gives first indication about an association between test anxiety, self-efficacy and mental images, even though the results are limited with respect to generalizability. Further investigations with respect to the impact of test-related mental images on the self-efficacy/test-anxiety linkage are needed.
Introduction: Until now, methods of pharmacovigilance as disproportionality analysis were not capable of proving the otherwise well-established increased bleeding risk related to antidepressants (ADs). As bleeding events with ADs often occur in combination with antithrombotics, they might not be considered causative of, but merely "linked" with, the bleeding event. Therefore, we hypothesized that the causality assessment of bleeding events in association with ADs and the competitive impact of antithrombotics are factors contributing to the non-findings of previous pharmacovigilance studies. Methods: We performed a case/non-case study based on data from VigiBaseTM and calculated reporting odds ratios (RORs) for 25 ADs. We used individual case safety reports (ICSRs) that were differently categorized in the database regarding their type of association between drug and event. Furthermore, we investigated the competitive impact of antithrombotics by comparing RORs with and without ICSRs related to antithrombotics. Results: Analysis of ICSRs that were categorized as causally associated resulted in the detection of only two signals (citalopram and escitalopram; upper gastrointestinal bleeding). Analysis of ICSRs irrespective of the type of association resulted in the detection of signals in 8 out of 25 ADs (regarding bleeding, in general, gastrointestinal bleeding and upper gastrointestinal bleeding). Consideration of ICSRs associated with antithrombotics as competitive substances did not have a major impact on signal detection in our analysis. Conclusion: Categorization of the type of association between drug and event affects the results of quantitative signal detection. Causality assessment seems to play a major role in signal detection, probably particularly concerning rare, unknown, or clinically insignificant adverse drug reactions. ADs appear to significantly increase the bleeding risk, even independent of antithrombotic comedication.
PURPOSE/BACKGROUND: The alleged primary mechanism underlying bleeding events associated with antidepressants is inhibition of serotonin uptake in platelets resulting in reduced platelet aggregability and activity, and prolonged bleeding time. There is some evidence that a substance's degree of serotonin reuptake inhibition in terms of its binding affinity to the serotonin transporter (SERT) affects the magnitude of bleeding risk increase. METHODS/PROCEDURE: To test this hypothesis, we performed data mining in the worldwide largest pharmacovigilance database (VigiBase) and conducted pharmacodynamically informed quantitative signal detection. Reporting odds ratios related to the standardized Medical Dictionary of Regulatory Activities query term "haemorrhages" and 24 antidepressants were calculated, and SERT binding affinities (pKi) were obtained and correlated (Pearson correlation). FINDINGS/RESULTS: A strong and statistically significant correlation between substance-related reporting odds ratios and SERT binding affinities was found (r = 0.63; 95% confidence interval, 0.30-0.82; P = 0.00097). IMPLICATIONS/CONCLUSIONS: Our findings strengthen the hypothesis that inhibition of serotonin uptake contributes to the antidepressant-related bleeding risk and suggest an association between the degree of the SERT binding affinity and the bleeding risk. This supports the preferential use of antidepressants with low or no SERT binding affinity in depressed patients at risk of bleeding.
Antidepressive Agents , Hemorrhage , Platelet Aggregation/drug effects , Selective Serotonin Reuptake Inhibitors , Serotonin Plasma Membrane Transport Proteins/metabolism , Adverse Drug Reaction Reporting Systems/statistics & numerical data , Antidepressive Agents/adverse effects , Antidepressive Agents/pharmacokinetics , Antidepressive Agents/therapeutic use , Data Mining/methods , Drug Monitoring/methods , Drug Monitoring/statistics & numerical data , Hemorrhage/chemically induced , Hemorrhage/metabolism , Hemorrhage/prevention & control , Humans , Pharmacovigilance , Platelet Activation/physiology , Risk Assessment , Selective Serotonin Reuptake Inhibitors/adverse effects , Selective Serotonin Reuptake Inhibitors/pharmacokinetics , Selective Serotonin Reuptake Inhibitors/therapeutic use
BACKGROUND: To date, disproportionality analysis has been unable to demonstrate the increased bleeding risk associated with antidepressant drugs, especially selective serotonin reuptake inhibitors. OBJECTIVE: We hypothesised that a potential signal for an increased bleeding risk may be mitigated by the effects of agents other than antidepressant drugs that are strongly associated with haemorrhages, especially antithrombotics. In addition, we investigated if the use of more specific search terms of the Medical Dictionary for Regulatory Activities facilitates the detection of signals. METHODS: Pharmacovigilance data from the Uppsala Monitoring Centre were used to calculate substance-specific reporting odds ratios (RORs) for all types of bleeding and gastrointestinal bleeding. Reporting odds ratios were calculated with and without antithrombotic comedication. RESULTS: Regarding any type of bleeding, no signals were found in association with antidepressant drugs. Concerning upper gastrointestinal bleeding, signals were found related to citalopram (ROR: 1.56 [95% confidence interval 1.11-2.20]) and escitalopram (ROR: 1.52 [95% confidence interval 1.03-2.25]). After removal of reports related to antithrombotics, these signals could no longer be detected, but a new signal related to St. John's Wort associated with haemorrhages was found (ROR: 1.50 [95% confidence interval 1.21-1.86]). CONCLUSIONS: Antithrombotics seem unlikely to have a major impact on the detection of the bleeding risk of antidepressant drugs. The different categorisation of adverse drug reactions regarding the strength of a causal relationship between a drug and an event in the database may be relevant for this negative finding.
Background: Interventions for improving reporting and management of adverse drug reactions (ADRs) need regular evaluations of attitude and knowledge of health care professionals regarding pharmacovigilance.Research design and methods: An exploratory survey among general practitioners in Germany was conducted.Results: We interviewed 302 individuals (participation rate 34.3%; mean age 54 yrs; 37.1% female). Underreporting was prevalent in the sample (only 16.6% had reported an ADR in 2015; average total number of ADR-reports was 5). We found awareness of the importance of pharmacovigilance and ADRs, information deficits (43% were not aware of the obligation to report ADRs), and several uncertainties regarding the detection and reporting of ADRs. The participants rated the German ADR reporting system as satisfactory (mean grade 3.7 ± 1.2) and criticized the expenditure of time (63.6%) and the overall complexity (47.4%). To increase the motivation to report ADRs, the majority requested the possibility to report by telephone (61.3%), feedback after reporting (49.3%), telephone consultations (47.4%), and more education and training in pharmacovigilance (31.1%), also during medical school (25.8%).Conclusions: We found evidence of objective and subjective need for further (mandatory) education and training in pharmacovigilance, already during medical school. Our results point to some shortcomings of the German pharmacovigilance system.
Adverse Drug Reaction Reporting Systems , Drug-Related Side Effects and Adverse Reactions/epidemiology , General Practitioners/statistics & numerical data , Health Knowledge, Attitudes, Practice , Adult , Aged , Cross-Sectional Studies , Female , Germany , Humans , Male , Middle Aged , Motivation , Pharmacovigilance , Surveys and Questionnaires
[This corrects the article DOI: 10.3389/fpsyt.2021.727687.].
PURPOSE: Most psychiatric drugs, such as antidepressants (AD) and antipsychotics (AP), may cause cardiac adverse events (CAE). We used summaries of product characteristics (SmPC) for assessing the likelihood of AD and AP to cause CAE. METHODS: We identified all original medicinal products (OMP) of AD and AP approved in Germany. We searched for their SmPCs using the online services of PharmaNet.Bund, Gelbe liste®, Rote Liste®, Fachinfo-Service®, and via manufacturer contact. We extracted frequencies of reported CAE (QT prolongation, Torsade de Pointes tachycardia, and ventricular arrhythmia) and performed a risk assessment. RESULTS: We obtained the SmPCs of 24 AD and 26 AP identified as OMP. Comparably high reported frequencies regarding QT prolongation were found for Invega® (paliperidone), Serdolect® (sertindole) (≥ 1/100 and < 1/10), and Zoloft® (sertraline) (≥ 1/10.000 and < 1/1000); regarding Torsade de Pointes tachycardia were found for Serdolect® (≥ 1/1000 to < 1/100), Zoloft®, and Trevilor® (venlafaxine) (≥ 1/10.000 and < 1/1000); regarding ventricular tachycardia for Solian® (amisulpride), Xomolix® (droperidol), Zyprexa® (olanzapine), and Trevilor® (≥ 1/10.000 and < 1/1000). CONCLUSION: The risk and frequency of CAE, as reported in the SmPCs, varied significantly among substances and between groups. There are more reports for AP than AD. The AP with the most frequently reported CAE (QT prolongation and Torsade de Pointes tachycardia) was Serdolect®; for AD, Zoloft® (QT prolongation, Torsade de Pointes tachycardia) and Trevilor® (Torsade de Pointes tachycardia and ventricular tachycardia) carried a higher cardiac risk.
Antidepressive Agents/adverse effects , Antipsychotic Agents/adverse effects , Arrhythmias, Cardiac/chemically induced , Germany/epidemiology , Humans , Long QT Syndrome/chemically induced , Tachycardia, Ventricular/chemically induced , Torsades de Pointes/chemically induced
BACKGROUND: Current research on borderline personality disorder report an association between emotionally dysregulated behaviors and intrusive mental imagery depicting similar scenes. Imagery rescripting techniques have proven effective in reducing intrusive mental imagery in numerous contexts. We developed a two session-short intervention in which intrusive mental images are identified, analyzed, and modified for daily rehearsal at home. This study aimed to reduce the negative emotions and cognitions associated with self-injurious behaviors by replacing unhealthy imagery with more adaptive content. METHODS: Seven females diagnosed with borderline personality disorder who reported intrusive mental imagery of dysregulated behaviors were recruited for participation. Each participant engaged in two individualized treatment sessions and daily homework requiring the rehearsal of modified imagery. Emotion regulation strategies, borderline symptom severity, and depressiveness were assessed before and after treatment. RESULTS: Acceptance was positive, as no patient dropped out from treatment. Symptom exacerbation was not observed. Borderline symptom reduction was noted and indicia of emotional dysregulation and negative affect declined. LIMITATIONS: The generalizability of results is limited by the small sample size and the absence of a control group. Conclusions: This new two-session short intervention was shown to decrease the emotionally dysregulated behaviors that accompany negative feelings in females with borderline personality disorder.
INTRODUCTION: Summaries of product characteristics (SmPC) of same-substance medications may feature content-related differences. This may cause difficulties regarding informed consent in the case of prescriptions of drugs in the context of the aut-idem regulation. A survey among family doctors (FD) and pharmacists (PH) was conducted in order to evaluate the usage behaviour of SmPCs, sources used to obtain information about drugs and the awareness of the existence of differences between SmPCs of same-substance medications. METHODS: An exploratory/non-representative, questionnaire- and telephone-based, semi-structured cross-sectional survey was performed (June to August 2018). RESULTS: Participation rate of FD and PH was 29.8 % (34/114) and 73.0 % (73/100), respectively. In the previous month, all PH and 82.4 % of FD said that they had used a SmPC at least once (p=0.001). FD used SmPCs 6.4±4.9 and PH 65.0±52.5 times a month (p<0.001). In both occupational groups SmPCs were used most frequently to obtain information about dosing and/or type of application (FD: 97.1 %; PH: 98.6 %) and contraindications (97.1 % and 86.3 %, resp.). In both samples, the internet was the most frequently used drug information source (FD: 97.1 %; PH: 98.6 %), followed by the Rote/Gelbe Liste (97.1 % and 71.2 %, resp.) and the SmPCs of the original product (52.9 % and 65.8 %, resp.) or generic drug (52.9 % and 61.6 %, resp.). Only 32.4 % of the FD vs. 79.5 % of PH believed that differences might exist between SmPCs of same-substance medications (p<0.001). FD stated that they never (11.8 %) or rarely (85.3 %) use SmPCs for informed consent. It was indicated that the aut-idem substitution is excluded in 10.3 %±5.0 (FD) and 9.6 %±6,1 (PH) of issued or received prescriptions. DISCUSSION: The results of the present survey indicate a low utilization rate of SmPCs by FD and little awareness of the existing differences of SmPCs of same-substance medications in this occupational group. Both aspects may impede proper information of patients, particularly in cases of aut-idem prescriptions of substances for which many same-substance medications with different SmPCs are available. CONCLUSION: Physicians should use SmPCs regularly and keep themselves informed about differences between SmPCs of same-substance medications.
Drugs, Generic , Pharmacists , Cross-Sectional Studies , Germany , Humans , Surveys and Questionnaires
BACKGROUND: Test anxiety is common in university students. Demanding schedules may contribute to the relatively low utilization of professional counseling, when compared to other anxiety disorders. A possible solution could be a psychotherapeutic short-term intervention. The present exploratory study implemented a short-term psychotherapeutic treatment, consisting of two imagery rescripting (IR) sessions. The efficacy of IR techniques has already been demonstrated in the treatment of various anxiety disorders including test anxiety. METHODS: Nine students suffering from test anxiety (m = 3, f = 6) underwent two weekly applied sessions of IR. Outcome variables were examined one week prior to (t1), immediately after (t2) and three months after (t3) the intervention, using self-evaluation questionnaires on test anxiety (PAF), depressive symptoms (BDI II), life satisfaction (FLZ), general self-efficacy and study-specific self-efficacy (WIRKALL; WIRK_STUD), intrusiveness of mental images (IFES), and change and acceptance (VEV; ZUF; BFTB). RESULTS: There were no dropouts. According to results from ZUF and BFTB, the participants where highly satisfied with the intervention. PAF scores decreased significantly over time (t1 to t3), whereas WIRKALL scores (t1 to t3) and WIRK_STUD scores (t1 to t3 and t2 to t3) increased significantly. IFES scores decreased immediately after the intervention (t1 compared to t2) and further after the follow-up (t1 to t3). No changes in BDI-II scores were observed. DISCUSSION: The findings indicate a high acceptance and efficacy of the two-session IR-intervention. Limits are the lack of a control group, and the small sample size. Further evaluation in future controlled studies is needed.
OBJECTIVE: Malignant catatonia (MC) is an extremely rare, life-threatening disorder. It is characterized by catatonic symptoms accompanied by autonomic instability, hyperthermia, and changes in laboratory values. In many cases, MC is not recognized as such. Evidence-based guidelines are essential to ensure quality of treatment, but what do current national and international guidelines recommend? METHOD: Online search for international guidelines from English-, French-, Italian-, and German-speaking countries whose medical care meets high standards addressing the treatment of MC. These were analyzed and compared regarding statements on MC, recommendations, and strength of scientific evidence. RESULTS: Fifteen of the identified guidelines were included. Only 5 of 15 comment on the treatment of MC. As for other rare diseases, no detailed recommendations are available. Suggested therapies are limited to benzodiazepines and electroconvulsive therapy. Levels of evidence and grades of recommendation are predominantly low. CONCLUSION: Many international guidelines do not mention MC. It is not possible to derive a clear algorithm for the treatment of MC from most current guidelines. A thorough update of most guidelines appears to be necessary. Lack of awareness and knowledge of MC among physicians and medical professionals might lead to inadequate or delayed care, worsened outcome, or death.
Catatonia/therapy , Global Health , Practice Guidelines as Topic/standards , Antipsychotic Agents/therapeutic use , Benzodiazepines/therapeutic use , Electroconvulsive Therapy/methods , Humans , Psychotherapy/methods , Rare Diseases
OBJECTIVE: In the case of prescriptions of pharmaceuticals in the context of the aut-idem-regulation the physician frequently does not know, which same-substance medication is dispensed in the pharmacy; the contemplable same-substance medications may differ in numerous features which raises questions regarding the obligation to give information and medical liability for medical malpractice. Currently, systematic evaluations regarding differences between summaries of product characteristics (SmPCs) of same-substance medications are missing. To determine size and type of those differences SmPCs of most (neuro)psychiatric drugs that are approved in Germany were evaluated regarding the number of listed contraindications (CI). METHODS: Basis for the selection of substances was the Anatomical Therapeutic Chemical (ATC) Classification System (group ATC N Nervous System). Substances that are approved in Germany for the treatment of mental disorders according to ICD-10 F were included. Brand-name medications and SmPCs were searched by means of further in- and exclusion criteria via the online services of PharmNet.Bund, Gelbe Liste, Rote Liste®/Fachinfo-Service® and communication with the manufacturer. RESULTS: Nâ=â941 SmPCs (=116 substances) were evaluated. Considering only the group of SmPCs withâ>â1 brand-name medication (nâ=â78; 67.2â%) differences in the number of CIs were found in more than the half of substances (Nâ=â43; 55.1â%). Considering indication groups most groups of SmPCs of same-substance medications with differences in the numbers of CIs were found in - considering only substances with >â1 brand-name medication - hypnotics and sedatives (77.8â%), anxiolytics (75.0â%), drugs for treatment of substance use disorders (66.7â%), antidepressants (61,9â%), anticonvulsant drugs and mood stabilizers (53.8â%), followed by antipsychotics (41.2â%), antidementia-drugs (20.0â%), and psychostimulants (0â%). Largest ranges regarding the number of CIs were found in the SmPCs of morphine (14), amitriptyline (8), chlorprothixene (6), lorazepam (6) and citalopram (4). CONCLUSION(S): In numerous (neuro-)psychopharmacologic substances differences exists between the SmPCs of the associated same-substance medications regarding the number of CIs. Due to the outstanding evaluation of content aspects of these differences and legal evaluation the relevance of this result for clinical practice is not yet clear.
Contraindications, Drug , Mental Disorders/drug therapy , Anticonvulsants , Antidepressive Agents , Antipsychotic Agents , Germany , Humans , Hypnotics and Sedatives
BACKGROUND: Volume reductions in brain structures of patients with schizophrenia spectrum disorder (SSD) have repeatedly been found in voxel-based morphometry MRI studies. Hence, an underlying neurodegenerative etiological component of SSD is currently being discussed. In recent years, the imaging method of optical coherence tomography (OCT) has shown its potential in evaluating structural changes in the retina in patients with confirmed neurodegenerative disorders, providing a window into the brain. METHODS: Twenty-six patients with schizophrenia or schizoaffective disorder and 23 age- and sex-matched healthy controls were examined with the Heidelberg Spectralis OCT system to derive a single-layer analysis of both retinas. The segmentation of retinal layers was manually corrected to minimize artifacts and software imprecisions. RESULTS: Compared to the control group, SSD patients showed reduced thickness and volume measurements for nearly all retinal layers, and these differences reached significance for macular volume, macular thickness, retinal nerve fiber layer (RNFL) and inner nucleiform layer (INL). Furthermore, a significant correlation between the duration of illness and the total volume of the RNFL was found. CONCLUSION: Our OCT measurements demonstrate reduced single retinal layer thickness in patients with SSD. In the context of the MRI volume changes, our results provide further evidence that structural changes seen in the brain of patients are also observable in the retina, potentially allowing further insights into the different components of the nervous system that are altered in this highly etiologically complex disorder.
Psychotic Disorders , Schizophrenia , Humans , Nerve Fibers , Retina/diagnostic imaging , Schizophrenia/diagnostic imaging , Tomography, Optical Coherence
