Wegen des Risikos der QTc-Verlängerung im EKG im Zusammenhang mit Citalopram und Escitalopram wurde im Jahr 2011 in Rote-Hand-Briefen (RHB) über eine Verringerung der maximalen Tagesdosis und eine neue Kontraindikation für die gleichzeitige Verordnung weiterer QTc-verlängernder Arzneimittel informiert. Frühere Untersuchungen zeigten eine unvollständige Umsetzung dieser Empfehlungen. In dieser Studie wurde erstmals der Effekt der RHB auf die Verordnung von Citalopram und Escitalopram bei Menschen mit Angsterkrankungen untersucht. Anhand von Verordnungszahlen aus dem Projekt „Arzneimittelsicherheit in der Psychiatrie e. V.“ (AMSP) wurde untersucht, ob der Anteil der Erkrankten mit einer höheren als der jetzt zugelassenen Dosierung („hohe Dosierung“) sowie der Anteil der Erkrankten mit QTc-verlängernder Komedikation nach den RHB abnahmen (gemeinsame Kategorie Citalopram/Escitalopram). Verordnungsdaten von n = 364 Personen aus der Zeit vor Erscheinen der RHB wurden mit Daten von n = 262 Personen nach den RHB verglichen. Der Anteil der Personen mit hoher Dosierung sank von 10,7 % auf 5,4 % (p = 0,019). Der Anteil der Personen mit QTc-verlängernder Komedikation lag vor Erscheinen der RHB bei 54,7 %, nach deren Publikation bei 51,5 % (p = 0,437). Wie in den früheren Studien sank der Anteil der Erkrankten mit hoher Dosierung, während die Verordnung QTc-verlängernder Komedikation nicht signifikant abnahm. Dies könnte daran liegen, dass konkrete Empfehlungen zur Dosierung besser umgesetzt werden können als die allgemein formulierte Kontraindikation einer QTc-verlängernden Komedikation. Empfehlungen in RHB sollten präzise formuliert sein und Hinweise zum Vorgehen in bestimmten klinischen Situationen geben.

BACKGROUND:In 2011, direct healthcare professional communication (DHPC) letters on citalopram and escitalopram were sent out to address the risk of QTc prolongation in the ECG. Healthcare professionals were informed about a reduction of the maximum recommended daily dose. Furthermore, a contraindication for QTc-prolonging co-medication was given. Previous studies noted that these instructions were implemented incompletely. AIM:For the first time, this study analyzed how the DHPC affected the prescription of citalopram and escitalopram in patients with anxiety disorders. METHODS:Drug utilization data from the project "Arzneimittelsicherheit in der Psychiatrie e. V." (AMSP) was used to examine whether the proportion of patients treated with a higher-than-recommended daily dose ("high dose") and the proportion of patients with QTc-prolonging co-medication would decrease post-DHPC (combined category of citalopram/escitalopram). RESULTS:Drug utilization data of n = 364 patients pre- and n = 262 patients post-DHPC were compared. The proportion of patients with high dose declined from 10.7% to 5.4% (p = 0.019). The proportion of patients with QTc-prolonging co-medication did not change significantly from pre- (54.7%) to post-DHPC (51.5%, p = 0.437). DISCUSSION:In accordance with previous studies, the proportion of high-dose patients decreased after DHPC publication while the proportion of patients with QTc-prolonging co-medication remained widely unchanged. The specific recommendation on daily dosage seems to have been better implemented than the broadly formulated contraindication of QTc-prolonging co-medication. Hence, DHPCs should be written precisely and give advice for specific clinical situations.

Introduction Several CYP2C19 genetic polymorphisms are described to be associated with ultrarapid (UM) or poor drug metabolism (PM), inducing treatment resistance and/or adverse drug events, and might therefore be related to pharmacoresistant severe mental health disease.

Reporting of new or unexpected adverse drug reactions of medicines that are subject to additional monitoring ("black triangle" label), such as the antipsychotic drug cariprazine, is of paramount importance to improve pharmacotherapy safety.

Objectives Drug-induced liver injury (DILI) has been associated with various antipsychotic drugs (APDs). Comparative studies between individual APDs are largely not available. Methods Antipsychotic drug utilisation data and reports of severe antipsychotic DILI were assessed by using data from an observational pharmacovigilance programme-Arzneimittelsicherheit in der Psychiatrie (AMSP)-during the period 1993-2016. Results Of the 333,175 patients treated with APDs, a total of 246 (0.07%) events of severe DILI were identified. Phenothiazines were associated with significantly higher rates of severe DILI (0.03%, 95% CI = 0.02-0.04) than thioxanthenes (0.01%, 95% CI = 0.00-0.02) or butyrophenones (0.01%, 95% CI = 0.00-0.01). Among individual drugs, olanzapine (0.12%, 95% CI = 0.10-0.16), perazine (0.09%, 95% CI = 0.05-0.15) and clozapine (0.09%, 95% CI = 0.10-0.12 ranked highest. In 78 cases (31.7%), combination therapies with antipsychotic and antidepressant drugs or with two or more APDs were considered responsible. Male sex and a diagnosis of mania were associated with significantly higher rates of severe DILI while older patients (>= 65 years old) were significantly less often affected. Conclusions In the present analysis of a representative psychiatric inpatient cohort, olanzapine, perazine, and clozapine were the most common individual APDs associated with severe DILI.

Background: Psychotropic drugs are the cornerstone of schizophrenia treatment, often requiring lifelong treatment. Data on pharmacotherapy in inpatient settings are lacking. Methods: Prescription data of schizophrenic inpatients within the time period 2000-2015 were obtained from the database of the Drug Safety Program in Psychiatry (AMSP). Data were collected at 2 index dates per year; the prescription patterns and changes over time were analyzed. Results: Among 30 908 inpatients (mean age 41.6 years, 57.8% males), the drug classes administered most often were antipsychotics (94.8%), tranquilizers (32%), antidepressants (16.5%), antiparkinsonians (16%), anticonvulsants (14.1%), hypnotics (8.1%), and lithium (2.1%). The use of second-generation antipsychotics significantly increased from 62.8% in 2000 to 88.9% in 2015 (P<.001), whereas the prescription of first-generation antipsychotics decreased from 46.6% in 2000 to 24.7% in 2015 (P<.001). The administration of long-acting injectable antipsychotics decreased from 15.2% in 2000 to 11.7% in 2015 (P=.006). Clopazine was the most often used antipsychotic, having been used for 21.3% of all patients. Polypharmacy rates (>= 5 drugs) increased from 19% in 2000 to 26.5% in 2015. Psychiatric polypharmacy (>= 3 psychotropic drugs) was present in 44.7% of patients. Conclusions: Combinations of antipsychotics and augmentation therapies with other drug classes are frequently prescribed for schizophrenic patients. Though treatment resistance and unsatisfactory functional outcomes reflect clinical necessity, further prospective studies are needed on real-world prescription patterns in schizophrenia to evaluate the efficacy and safety of this common practice.

Patients with schizophrenia suffer from stigma and discrimination due to their illness. Yet it is not well examined how experiences of stigma and discrimination express at the early illness stage and how they develop subsequently. Therefore, clinical and psycho-social correlates of stigma experiences and perceived stigma are analyzed in patients with first-episode schizophrenia over the course of 1 year after their first in-patient treatment. Questionnaire data assessed within the multi-centre-RCT “First-Episode Study” of the German Research Network on Schizophrenia were analyzed. Patients with first-episode schizophrenia were assessed 8 weeks after their first in-patient treatment (post-acute assessment) and 1 year later. N = 48 (post-acute) and N = 24 (1-year follow-up) patients provided questionnaire data appropriate for analyses, with N = 12 dyads. These data included burden due to stigma experiences (B-STE), perceived stigma (PDDQ), clinical (PANSS, CDSS, CGI, GAF, SAS) and psycho-social factors (LQLP, FSNK-self-esteem, KK-Scale). Cross-lag-correlation models showed a causal relation between stigma experiences (post-acute) and reduced self-esteem after 1 year. Multiple regression models revealed different models for experienced and perceived stigma. Factors associated with higher stigma experiences were older age, worse clinical global impression, better social adjustment, lower self-esteem, and the belief that illness is not driven by chance or fate. The different associations between psycho-social factors and stigma experiences and perceived stigma demonstrate the complexity of this inter-relationship. The results have practical implications for psycho-educational and other therapeutic interventions addressing stigma coping. Since the sample was small and selective, replication studies are needed.

We demonstrate a 48-year old woman with schizophrenia and a 20 year history of lorazepam with daily use about 6 mg. Low serum levels of lorazepam were monitored 11 weeks during ambulant care.

Mayor reports important facts about perinatal psychological distress.1 Postpartum depression is a severe affective disorder and can affect both sexes. Onset is typically between one week and four months after childbirth. Causes are a combination of biological factors (hormonal changes) …

Patienten mit psychischen Erkrankungen, insbesondere mit Schizophrenie, sind von Stigmatisierung und Diskriminierung betroffen. Bei ersterkrankten Patienten stellt das Stigma häufig ein zusätzliches Hindernis für die Erkennung und Behandlung dar. Bislang existieren noch keine Selbstbeurteilungsinstrumente, um die allgemeine Belastung durch Erlebnisse von Stigma und Diskriminierung zu erheben.

Bolland and colleagues describe the role of vitamin D supplementation and the insufficient studies published in recent years.1 Observational studies have associated low vitamin D status with a wide range of non-skeletal adverse clinical outcomes. But meta-analyses of randomised controlled trials show that vitamin D supplementation alone does not improve …

Tricyclic antidepressants (TCAs) are associated with well-known risks like anticholinergic side effects, orthostatic hypotension, weight gain as well as sedation. This case report presents a 70-year old man with a severe depression and prostata hyperplasia.

Over the past 20 years the use of second generation antipsychotics has shifted from schizophrenia to affective disorders. Pringsheim and colleagues described the benefits and risks of quetiapine as adjunctive treatment in major depressive disorder.1 However, they did not mention some …

Zusammenfassung Hintergrund Patienten mit psychischen Erkrankungen, insbesondere mit Schizophrenie, sind von Stigmatisierung und Diskriminierung betroffen. Bei ersterkrankten Patienten stellt das Stigma häufig ein zusätzliches Hindernis für die Erkennung und Behandlung dar. Bislang existieren noch keine Selbstbeurteilungsinstrumente, um die allgemeine Belastung durch Erlebnisse von Stigma und Diskriminierung zu erheben. Material und Methoden Bei 48 ersterkrankten Schizophreniepatienten (Teilnehmer der multizentrischen „Ersterkrankten-Langzeitstudie“ des Kompetenznetz Schizophrenie) wurde ein neu entwickelter Selbstbeurteilungsfragebogen zur Erfassung der Belastung durch stigmatisierende Erlebnisse (B-STE) erhoben. Als mögliche Korrelate wurden Psychopathologie (CGI, PANSS, CDSS, HAM-D), Funktionsfähigkeit (GAF), soziale Anpassung (SAS), Selbstwert (FSKN) sowie Lebensqualität (LQLP), subjektives Wohlbefinden unter Neuroleptika (SWN) und antizipiertes Stigma (PDDQ) untersucht. Ergebnisse Von den Befragten wiesen 25 % eine erhöhte Belastung durch stigmatisierende Erlebnisse auf, was mit reduzierter Lebensqualität und Wohlbefinden, reduziertem Selbstwert und antizipiertem Stigma korreliert. Es gibt Hinweise darauf, dass im klinischen Globalurteil (CGI) schwerer erkrankt eingeschätzte Patienten, die gleichzeitig jedoch über eine relativ gute soziale Funktionsfähigkeit (SAS) verfügen, besonders stark durch stigmatisierende Erlebnisse belastet sind. Schlussfolgerung Der hier vorgestellte Kurzfragebogen „Belastung durch stigmatisierende Erlebnisse“ (B-STE) kann bei der Klärung der Frage helfen, ob im Einzelfall für die Bewältigung von Stigmatisierungserlebnissen therapeutische und psychoedukative Maßnahmen sinnvoll sind.

Thyroid diseases are often associated with psychiatric disorders. The prevalence of autoimmune thyroiditis in the general population is estimated to be at about 5–14 %. A clinical study was conducted to evaluate the association between autoimmune thyroiditis and depression in psychiatric outpatients. Fifty-two patients with depression and nineteen patients with schizophrenia (serving as control group), attending a psychiatric outpatient unit, were included. In addition to the measurement of thyroid-stimulating hormone (TSH), free triiodothyronine, free thyroxine, antithyroid peroxidase (anti-TPO) antibodies, and anti-thyroglobulin antibodies, ultrasound examination of the thyroid gland was performed. The proportion of pathologically increased anti-TPO levels in patients with depression was high. Furthermore, the distribution of pathologically increased anti-TPO levels was significantly (χ 2 = 5.5; p = 0.019) different between patients with depression (32.7 %) and patients with schizophrenia (5.3 %). In a gender- and age-adjusted logistic regression, the odds ratio of uni- or bipolar patients with depression for an autoimmune thyroiditis was ten times higher (95 % CI = 1.2–85.3) when compared with schizophrenia patients. TSH basal level did not differ between patients with depression and patients with schizophrenia. Our study demonstrates a strong association between anti-TPO levels, which are considered to be of diagnostic value for autoimmune thyroiditis (in combination with a hypoechoic thyroid in ultrasonography) with uni- or bipolar depression. It should be noted that the routinely measured TSH level is not sufficient in itself to diagnose this relevant autoimmune comorbidity.

We present a case of a vascular parkinsonism and severe sedation associated with quetiapine, aripiprazole and valproic acid. The patient was suffering from a bipolar affective disorder. Pharmacokinetic and pharmacodynmic aspects and interaction risks especially in elderly patients were demonstrated. These adverse drug reactions were registrated from the German pharmacovigilance study “Arzneimittelsicherheit in der Psychiatrie”(AMSP).

RATIONALE:There is little clinical data available about seizure rates in psychiatric inpatients, and there are no studies with reference data to the frequencies of antidepressant (AD) use for this important clinical population.OBJECTIVE:This study investigates seizure rates during AD treatment in psychiatric inpatient settings, drawn from the transnational pharmacovigilance programme Arzneimittelsicherheit in der Psychiatrie (AMSP) in relation to the known frequencies of ADs used in the participating clinics. Comparisons are made to former publications and their limitations.RESULTS:Seventy-seven cases were identified with grand mal seizures (GMS) during AD treatment between 1993 and 2008, with a total number of 142,090 inpatients under surveillance treated with ADs in the participating hospitals. The calculated overall rate of reported seizures of patients during AD treatment in this collective is 0.05 % for ADs imputed alone or in combination with other psychotropic drug groups and 0.02 % when only ADs were given and held responsible for GMS. The patients receiving tri- or tetracyclic ADs (TCAs) had a 2-fold risk to develop a seizure as compared to the overall average rate in this sample. In 11 cases, there was only one AD imputed--the majority of these cases (9/11) were TCA. Monotherapy with selective serotonin reuptake inhibitors (SSRI) or dual serotonin and noradrenaline reuptake inhibitors (SNRI) were never imputed alone in this sample.CONCLUSIONS:The results of the study favour the assumption that SSRIs, noradrenergic and specific serotonergic antidepressants (NaSSA) and dual SNRI might be more appropriate than TCAs for the treatment of psychiatric patients with an enhanced seizure risk.