[Medical societies in Germany call for a ban on flavors in e-cigarettes - A Position Paper of the German Respiratory Society (DGP) in cooperation with other professional associations and organizations]. / Medizinische Fachgesellschaften fordern ein Verbot von Aromen in E-Zigaretten.

E-cigarettes are primarily used by teenagers and young adults. Flavors in e-cigarettes increase their attractiveness and encourage young people and adults to start using them. This exposes young people in particular to the risk of nicotine addiction and various toxic substances from the aerosol of e-cigarettes. There are indications that various flavors in e-cigarettes are harmful to health, although toxicological studies are still lacking for the majority of flavors. There is a need for independent scientific investigations in this area. The scientific societies involved are calling for a ban on flavors in e-cigarettes, a ban on disposable e-cigarettes, effective regulation of the sale of e-cigarettes and effective control and implementation of the provisions for the protection of minors.

Long-Term Outcomes of Depression Treatment With Hypnotherapy or Cognitive Behavioral Therapy.

ABSTRACT: In a recent randomized controlled trial of mild to moderate depression, hypnotherapy (HT) was noninferior to cognitive behavioral therapy (CBT) after 6 months of outpatient treatment. In the present article, we extended the results in a secondary analysis and investigated how HT compares with CBT 1) during the course of the self-rated depressive symptoms throughout the 12-month follow-ups, 2) with regard to the rates of full remission, and 3) for the time to remission after treatment. Of the 152 randomized patients with current depression, 136 were available for the follow-up analyses. The course of self-rated depressive symptoms during follow-ups was analyzed with linear mixed-effects models. Time to a full remission, defined as eight consecutive weeks without depression, was compared between groups in a survival analysis. The self-reported depressive symptoms could be maintained on a low symptom level during the 12-month follow-up for both HT and CBT. Overall, both treatments achieved comparably high long-term remission rates of 73% after a median of 30 weeks. Outpatient psychotherapy with HT achieved good long-term results mostly comparable to CBT.

The dual role dilemma of liver transplantation health care professionals.

BACKGROUND: Similar to many other countries, in Germany patients with alcohol-related liver disease are obliged to prove their abstinence before being accepted on a waitlist for liver transplantation. Health care professionals (HCPs) must both treat patients and ensure that patients have proven their abstinence. The aim of this exploratory study was to develop a deeper understanding of how HCPs deal with this dual role. METHODS: The study used semi-structured interviews as the source of data. 11 healthcare professionals from ten of the 22 German transplant centers were interviewed. After transcription, a qualitative content analysis was performed. RESULTS: We found that these HCPs faced an ethical dilemma, as they must balance the roles of being both a treatment provider (the therapist role) and an assessor (the monitoring role). To solve this dilemma, the strategy seems to be a tendency for the HCPs to take on one dominant role amongst these two roles. HCPs who prefer to take on the therapist role seem to feel burdened by the 6-month abstinence rule and the obligation to monitor their patients. HCPs who prefer to take on the monitoring role tend to have negative assumptions about the patients. HCPs also reported the impression that patients perceive HCPs as more involved in monitoring and less open to the therapeutic role. From this it can be deduced that current regulations and structures lead both to stress for HCPs and to suboptimal therapy for those affected. CONCLUSIONS: The results showed that current transplantation guidelines can have a negative impact on both patient care and the burdens on the HCPs. From our point of view, there are various changes that could be made to the current clinical practice that would help solve this dilemma. For instance, integrating other assessment criteria that are more closely adapted to the health status trajectory and psychosocial background of the individual patient would be both possible and would lead to improvements in practice.

[Control and care structures at transplant centers for patients with ethyltoxic cirrhosis while waiting for a liver transplant: A qualitative survey of practitioners.] / Erhebung der Versorgungsstrukturen an Transplantationszentren für Patient*innen mit äthyltoxischer Leberzirrhose vor einer Lebertransplantation. Eine qualitative Befragung von Behandler*innen.

OBJECTIVE: The aim of this study was to record the current care and control structures in place for patients with ethyltoxic liver cirrhosis while being prepared for a liver transplant (LTX) at German transplant centers. In addition, it was also intended to analyze the associated barriers as well as the view of the practitioners on ways to improve care of this patient group. METHODS: In an exploratory descriptive qualitative design, 11 interviews with practitioners from 10 of the 22 German LTX centers were conducted and analyzed using qualitative content analysis. RESULTS: There were considerable differences in the care and control structures in place at the LTX centers. Addiction therapy counseling or treatment were not integrated into the treatment concept at all centers. Structural barriers arose from insufficient funding and staffing. Practitioners recommended expansion of treatment options as well as standardizing treatment concepts. DISCUSSION: The results of our study point to a need for action both in the area of the structures of the individual LTX centers and overall at the system level. Taking into account current standards of addiction medicine, our results could serve as a basis for the development of treatment concepts and recommendations for optimizing standard care before LTX.

[Hypnotherapy and cognitive-behavioral therapy for depression - Results from the three and a half year follow-up of a randomized controlled non-inferiority study]. / Hypnotherapie und Verhaltenstherapie bei Depressionen ­ Ergebnisse der Dreieinhalb-Jahres-Katamnese einer randomisiert-kontrollierten Nicht-Unterlegenheitsstudie.

OBJECTIVE: The scientific approval of hypnotherapy for certain mental disorders is still not confirmed. In a randomized-controlled study comparing the efficacy of hypnotherapy (HT) with cognitive behavioral therapy (CBT) for mild to moderate depressive episodes, a non-inferiority of HT compared to CBT could be found. The aim of this study was to examine depressive symptomatology in the long-term course three and a half years after end of the treatment. METHODS: A total of 152 randomized patients received outpatient individual psychotherapy with 16 to 20 sessions over a period of six months. All were invited to participate in a follow-up three and a half years after the end of treatment where depressive symptoms were assessed via self- and clinician-ratings. In the per-protocol (PP) analysis, only those with available data were included, but a comparison of characteristics was made with individuals without participation in the follow-up survey. An additional intention-to-treat (ITT) analysis was conducted with multiple imputed data for missing data. RESULTS: A total of 71 subjects (46.7%) participated in the follow-up. The noninferiority in the percentage symptom reduction assessed with the clinician-rating of HT compared with CBT was confirmed in the PP and the ITT sample. The symptom improvement in self- and clinician-rating by the end of therapy persisted during the follow-up. Response rates and remission rates for both self- and clinician-ratings are reported. CONCLUSION: In this study, indications were found that HT was noninferior to CBT in the treatment of depression, even in the long term. Further studies should examine the efficacy of HT in larger multicenter samples and identify predictors of individual treatment success.

[Smoking Cessation in Patients with COPD]. / Tabakentwöhnung bei COPD.

Tobacco dependence is a common comorbidity in patients with COPD (Chronic Obstructive Pulmonary Disease) that negatively affects the course of the disease. However, clinically relevant improvement in COPD can only be achieved by complete and permanent abstinence. Therefore, abstinence from tobacco use is a central therapeutic concept in smoking patients with COPD and requires specific and targeted treatment.After detailed documentation of smoking behaviour and motivational counseling outlining the risks of smoking, all such patients shall be offered a structured therapy for tobacco cessation. There is high-quality evidence for the effectiveness of a combination therapy of behavioral therapy and medication (to treat the withdrawal syndrome). Due to insufficient data, there is currently no recommendation for the use of e-cigarettes as a primary option for a cessation attempt.Smoking is the most important cause of COPD. Smoking cessation is the most effective and cost-efficient single intervention to reduce the risk of developing and progressing COPD.

The effects of hypnotherapy compared to cognitive behavioral therapy in depression: a NIRS-study using an emotional gait paradigm.

Hypnotherapy (HT) is a promising approach to treating depression, but so far, no data are available on the neuronal mechanisms of functional reorganization after HT for depressed patients. Here, 75 patients with mild to moderate depression, who received either HT or Cognitive Behavioral Therapy (CBT), were measured before and after therapy using functional near-infrared spectroscopy. We investigated the patients' cerebral activation during an emotional human gait paradigm. Further, rumination was included as predictor. Our results showed a decrease of functional connectivity (FC) between two regions that are crucial to emotional processing, the Extrastriate Body Area (EBA) and the Superior Temporal Sulcus (STS). This FC decrease was traced back to an activation change throughout therapy in the right STS, not the EBA and was only found in the HT group, depending on rumination: less ruminating HT patients showed a decrease in right STS activation, while highly ruminating patients showed an increase. We carefully propose that this activation change is due to the promotion of emotional experiences during HT, while in CBT a focus lay on activating behavior and changing negative cognitions. HT seemed to have had differential effects on the patients, depending on their rumination style: The increase of right STS activation in highly ruminating patients might mirror the improvement of impaired emotional processing, whilst the decrease of activation in low ruminating patients might reflect a dismissal of an over-compensation, associated with a hyperactivity before therapy. We conclude that HT affects emotional processing and this effect is moderated by rumination.

S3 Guideline "Smoking and Tobacco Dependence: Screening, Diagnosis, and Treatment" - Short Version.

INTRODUCTION: In addition to the prevention of tobacco consumption, the establishment and assurance of high-quality treatment for harmful use and dependence on tobacco products remains an important health-related task in Germany. Regular updating of the Association of the Scientific Medical Societies (AWMF) S3 guideline "Smoking and Tobacco Dependence: Screening, Diagnosis, and Treatment" (Tobacco Guideline) offers a sustainable and reputable source of knowledge on smoking cessation. METHODS: Under the auspices of the German Society for Psychiatry, Psychotherapy, Psychosomatics, and Neurology (DGPPN) and the German Society for Addiction Research and Addiction Therapy (DG-Sucht), the Tobacco Guideline was revised in 2019-2020 by 63 experts, who were involved in the development process of the text, in 11 working groups. Undue influence of conflicts of interest on the guideline could be minimized through careful conflict of interest management. Delegates from 50 professional societies discussed the 80 guideline recommendations and voted online. RESULTS: In addition to recommendations for screening and diagnostics, the Tobacco Guideline takes a positive stance towards the use of low-threshold counseling and support services. If, due to the severity of the tobacco-related disorder, brief counseling, telephone counseling, or internet- or smartphone-based methods are not sufficiently effective, individual or group behavioral therapy, possibly in combination with medication, is indicated. If nicotine replacement therapy is not effective, varenicline or bupropion should be offered. Alternative strategies with a lower level of recommendation are hypnotherapy, mindfulness-based treatments, or medication with cytisine. In adolescents and pregnant women, the use of medication should be limited to well-specified exceptions and nicotine replacement. The mean agreement with the recommendations reached a value of 98%. A general overview of the treatment recommendations of the Tobacco Guideline is provided by three clinical algorithms.

German Guidelines on Screening, Diagnosis, and Treatment of Alcohol Use Disorders: Update 2021.

INTRODUCTION: Alcohol consumption in Germany is associated with considerable health and economic consequences. In addition to prevention, the early detection and differential treatment of those affected play an important role. The guideline "Screening, Diagnosis, and Treatment of Alcohol Use Disorders" forms the basis of this care for people suffering from alcohol use disorders. Regular updates integrate the current state of research evidence and clinical expertise. METHODS: Under the auspices of the German Society for Psychiatry, Psychotherapy, Psychosomatics, and Neurology and the German Society for Addiction Research and Addiction Therapy e.V. (DG-Sucht), the 2019-2020 S3 guideline on alcohol was revised by eight working groups. Thirty-five professional societies participated in a structured consensus process to deliberate the recommendations. Potential conflicts of interest were examined in advance, documented, and taken into account during the voting on the recommendations. RESULTS: The guideline provides recommendations on screening and brief interventions for different groups of people, as well as on treatment of individuals in the acute and post-acute phases of withdrawal. Special emphasis was placed on the treatment of comorbid somatic and psychological disorders. In addition, recommendations for specific groups of people (e.g., children and adolescents, pregnant women) have been made and adapted to the German care landscape.

Researching Alcohol Consumption During Pregnancy. Opportunities and Challenges With Two Methods of Data Acquisition.

Qualitative research methods, primarily interviews, have become more common in the field of addiction research. Other data sources were often neglected, although sources such as social media can offer insights into the realities of people, since social media also plays a relevant role in today's living environments. This article examines the use of online forums as an underutilized data source in contrast to telephone interviews, to identify methodological opportunities and challenges. We analyzed nine discussion threads and seven interviews about 'alcohol consumption during pregnancy'. Discursive comparison of the results was performed with a focus on sampling issues, comparability and risks for participants and researchers. Key issues were present in both data sources. People with different opinions were openly hostile in forums, while tolerance was more often expressed in interviews. The interviews showed a rather mild communication style, which could be attributed to social desirability. In the forum discussions, the participants often expressed themselves very directly. To comprehensively grasp the subject matter of the research, it is important to recognize the types of communication promoted by different data sources. These results have implications for research about female substance use. Knowledge of the issues will bestow a valuable contribution to researchers working in the field of substance use to help develop appropriate research approaches, as they engage in research into this highly stigmatized and controversial area.

[Tobacco Cessation - The Underused Potential in Clinical Routine]. / Tabakentwöhnung ­ die bisher wenig genutzte Chance im ärztlichen Alltag.

Tobacco control, psychosocial and medical assistance regarding tobacco cessation is still a hidden potential within the German health care system. So far doctors rarely talk to their patients about their smoking status and physical and psychological benefits of quitting.This paper focusses on recommended current diagnostic and treatment standards, as well as evidence-based methods to address the topic on how to stop smoking and its association with certain diseases such as COPD, lung cancer and COVID-19 infection. The role of e-cigarettes as a cessation tool and its health related risks are critically examined. Consequences and advice how to implement smoking cessation procedures into daily practice are presented.

Significance and clinical impact of routinely tested urinary ethyl glucuronide after liver transplantation - development of a risk score.

Alcohol abuse after liver transplantation can seriously impact graft and patient survival. However, to date, there is no defined standard procedure to identify patients consuming alcohol after liver transplantation. The aim of this study was to analyze the diagnostic value and clinical impact of routinely measured urinary ethyl glucuronide (uEtG) - a metabolite of ethanol - in patients after liver transplantation. Data of 362 consecutive patients after liver transplantation who visited the University Hospital of Tuebingen for outpatient follow-up were analyzed. Forty-eight patients (13%) displayed positive uEtG results. The uEtG positive group contained significantly more patients with pretransplant alcoholic liver disease. However, two thirds of the uEtG positive patients had no history of pretransplant alcoholic liver disease. Several clinical parameters were significantly associated with positive uEtG. In order to enable a more cost-effective application of uEtG in the future, a clinical risk score was developed (specificity 0.95). In conclusion, routine testing for uEtG reveals a considerable percentage of patients practicing alcohol intake after liver transplantation. Application of our proposed risk score could help focusing uEtG testing on patients at risk.

Longitudinal measurement invariance of the patient health questionnaire in a German sample.

BACKGROUND: The Patient Health Questionnaire-8 (PHQ-8) is a screening questionnaire of depressive symptoms. However, it is unknown whether it is equivalent across time and between groups of individuals. The aim of our paper was to test whether the PHQ-8 has the same meaning in two groups of individuals over time. METHODS: Primary care patients were proactively recruited from three German cities. PHQ-8 data from a baseline assessment (n = 588), two assessments during the intervention (n = 246/225), and a six (n = 437) and 12 months (n = 447) follow-up assessment were first used to examine the factor structure of the PHQ-8 by confirmatory factor analysis (CFA). The best fitting factor solution was then used to test longitudinal invariance across time and between intervention and control group by Multiple Group CFA. RESULTS: A two-factor structure consistently showed the best model fit. Only configural longitudinal invariance was evidenced when the baseline assessment was included in the analysis. Without the baseline assessment, strict longitudinal invariance was shown across the intervention and the follow-up assessments. Scalar invariance was established between the intervention and control group for the baseline assessment and strict invariance between groups and across the 6- and 12-month follow-up assessments. CONCLUSIONS: The lack of longitudinal invariance might be attributed to various differences between the baseline assessments and all following assessments, e.g., assessment mode (iPad vs telephone), potential changes in symptom perception, and setting. TRIAL REGISTRATION: DRKS0001163 5, date of trial registration: 20.01.2017; DRKS00011637 , date of trial registration: 25.01.2017.

[Potential Savings in Treatment Costs of COPD through Smoking Cessation: Modeling for DMP COPD in Germany - Scientific Action Group on Tobacco Cessation (WAT) e. V.] / Das Einsparpotenzial der Behandlungskosten bei COPD durch Rauchstopp ­ Modellierung für DMP COPD in Deutschland.

Based on real-life data for the stage distribution of COPD patients (GOLD) and the actual stage-related treatment costs in a large nationwide cohort study (COSYCONET) 1, the influence of the reduced smoking rate on treatment costs was determined for the scenario of a reduction in the smoking rate of 26 % in this patient group by 10 percentage points to 16 %. The assumption was made that with a reduced smoking rate, lower stages (I/II) will be more strongly represented, while higher and more cost-intensive stages (III/IV) will be proportionally reduced. The intervention to achieve tobacco abstinence was calculated for the rough model calculations with the typical costs of a guideline-compliant treatment by a behavioral therapy group cessation program and the parallel use of medication support 2 3. The result showed a potential reduction of case costs by 10.5 %, not including reduction in costs associated with treatment of comorbidities.

[Opinions on Alcohol Consumption During Pregnancy and The Role of The Medical Staff as an Expert in This Regard - A Grounded Theory Analysis of Online Forum Discussions]. / Meinungen zum Alkoholkonsum in der Schwangerschaft und zur diesbezüglichen ExpertInnenrolle von medizinischem Fachpersonal.

BACKGROUND: Alcohol consumption during pregnancy carries many risks for the unborn child. Despite preventive measures, some pregnant women consume alcohol. The aim of this study is to identify possible reasons for consumption during pregnancy and also to shed light on the attribution of an expert role to medical professionals by those affected. METHODS: In this study, 9 discussion threads from online forums on the topic of alcohol consumption during pregnancy with a total of 115 discussion participants were analyzed using grounded theory. The discursive validation of the results took place in the research team. RESULTS: It turned out that the individual definition of the mother role has an influence on consumer behavior. Women who are very concerned about the child's well-being occasionally used alcohol in stressful situations or on social occasions, but often reported a guilty conscience after the consumption. Women who gave more weight to their own needs were more likely to consume for pleasure or because they felt they were being patronized by prohibitions. An equitable doctor-patient relationship and detailed, non-directive information were identified as beneficial factors for ascribing the expert role to the gynecologist. On the other hand, a paternalistic attitude and the issuing of bans proved to be a hindrance. DISCUSSION: All women showed a high need for information about alcohol consumption during pregnancy. The doctor-patient relationship seems to play an important role in conveying information. In addition, it became clear that the desire for support in women striving for abstinence is not being sufficiently fulfilled. CONCLUSION: Alcohol consumption during pregnancy should be addressed regularly in the care of all pregnant women. In addition to information on consumption risks, information on support offers is relevant.

Feasibility and Acceptability of an Intervention Providing Computer-Generated Tailored Feedback to Target Alcohol Consumption and Depressive Symptoms in Proactively Recruited Health Care Patients and Reactively Recruited Media Volunteers: Results of a Pilot Study.

BACKGROUND: A pre-post pilot study was conducted to test the feasibility, acceptability, and potential effectiveness of a fully automatized computer-based intervention targeting hazardous drinking and depressiveness in proactively recruited health care patients (HCPs). To address the importance of the sample selection when testing interventions, HCPs were compared to media recruited volunteers (MVs). METHOD: In a multicenter screening program 2,773 HCPs were screened for hazardous drinking and depressive symptoms. MVs were recruited via media solicitation. Over a period of 6 months, study participants received 6 individualized counseling letters and weekly short messages. Pre-post data were analyzed for 30 participants (15 HCPs, 15 MVs). Intervention acceptability was assessed in post-intervention interviews conducted with 32 study participants. RESULTS: MVs showed higher problem severity and motivation to change than HCPs. Over the course of the intervention both subsamples reduced regular binge drinking (HCPs: p = 0.016; MVs: p = 0.031) and depressiveness (HCPs: p = 0.020; MVs: p < 0.001). MVs further reduced average daily alcohol consumption (p = 0.034). The intervention received positive ratings from both subsamples, the alcohol module was rated more favorably by MVs than by HCPs (p = 0.012). Subsamples further differed in terms of intervention usage (p = 0.013). CONCLUSION: The intervention was technically and logistically feasible, well accepted, and may have the potential to reduce hazardous drinking and depressive symptoms in different populations. Subsamples differed in terms of problem severity, motivation to change, intervention usage, pre-post changes, and attitudes toward the intervention, showing that intervention development should involve the intended target populations to avoid biased conclusions on intervention effectiveness and acceptability.

[Medicinal cannabis and cannabis-based medication: an appeal to physicians, journalists, health insurances, and politicians for their responsible handling]. / Medizinalcannabis und cannabisbasierte Arzneimittel: ein Appell an Ärzte, Journalisten, Krankenkassen und Politiker für einen verantwortungsvollen Umgang.

Since the adoption of the law of March 6, 2017, any German physician can prescribe medical cannabis flowers and cannabis-based magistral and finished medicinal products. No specific indications for prescriptions are provided in the law. The statutory health insurance companies bear the costs once an application for cost coverage has been approved by the Medical Service of the Health Funds. The German associations of psychiatry (child, adolescents, and adults), neurology, palliative care, addictology, and pain medicine are watching these developments in the media, politics, and medical world with concern due to: the option to prescribe cannabis flowers despite the lack of sound evidence and against the recommendations of the German Medical Association; the lack of distinction between medical cannabis flowers and cannabis-based magistral and finished medical products; the indiscriminately positive reports on the efficacy of cannabis-based medicines for chronic pain and mental disorders; the attempts by the cannabis industry to influence physicians; the increase in potential indications by leaders of medical opinion paid by manufacturers of cannabis-based medicines. The medical associations make the following appeal to journalists: To report on the medical benefits and risks of cannabis-based medicines in a balanced manner. To physicians: to prescribe cannabis-based medicines with caution; to prefer magistral and finished medicinal products over cannabis flowers. To politicians: to consider data according to the standards of evidence-based medicine when making decisions and provide financial support for medical research into cannabis-based medicines.

A Face-Aging App for Smoking Cessation in a Waiting Room Setting: Pilot Study in an HIV Outpatient Clinic.

BACKGROUND: There is strong evidence for the effectiveness of addressing tobacco use in health care settings. However, few smokers receive cessation advice when visiting a hospital. Implementing smoking cessation technology in outpatient waiting rooms could be an effective strategy for change, with the potential to expose almost all patients visiting a health care provider without preluding physician action needed. OBJECTIVE: The objective of this study was to develop an intervention for smoking cessation that would make use of the time patients spend in a waiting room by passively exposing them to a face-aging, public morphing, tablet-based app, to pilot the intervention in a waiting room of an HIV outpatient clinic, and to measure the perceptions of this intervention among smoking and nonsmoking HIV patients. METHODS: We developed a kiosk version of our 3-dimensional face-aging app Smokerface, which shows the user how their face would look with or without cigarette smoking 1 to 15 years in the future. We placed a tablet with the app running on a table in the middle of the waiting room of our HIV outpatient clinic, connected to a large monitor attached to the opposite wall. A researcher noted all the patients who were using the waiting room. If a patient did not initiate app use within 30 seconds of waiting time, the researcher encouraged him or her to do so. Those using the app were asked to complete a questionnaire. RESULTS: During a 19-day period, 464 patients visited the waiting room, of whom 187 (40.3%) tried the app and 179 (38.6%) completed the questionnaire. Of those who completed the questionnaire, 139 of 176 (79.0%) were men and 84 of 179 (46.9%) were smokers. Of the smokers, 55 of 81 (68%) said the intervention motivated them to quit (men: 45, 68%; women: 10, 67%); 41 (51%) said that it motivated them to discuss quitting with their doctor (men: 32, 49%; women: 9, 60%); and 72 (91%) perceived the intervention as fun (men: 57, 90%; women: 15, 94%). Of the nonsmokers, 92 (98%) said that it motivated them never to take up smoking (men: 72, 99%; women: 20, 95%). Among all patients, 102 (22.0%) watched another patient try the app without trying it themselves; thus, a total of 289 (62.3%) of the 464 patients were exposed to the intervention (average waiting time 21 minutes). CONCLUSIONS: A face-aging app implemented in a waiting room provides a novel opportunity to motivate patients visiting a health care provider to quit smoking, to address quitting at their subsequent appointment and thereby encourage physician-delivered smoking cessation, or not to take up smoking.

Factors Influencing the Cardiovascular Response to Subanesthetic Ketamine: A Randomized, Placebo-Controlled Trial.

Background: The increasing use of ketamine as a potential rapid-onset antidepressant necessitates a better understanding of its effects on blood pressure and heart rate, well-known side effects at higher doses. For the subanesthetic dose used for depression, potential predictors of these cardiovascular effects are important factors influencing clinical decisions. Since ketamine influences the sympathetic nervous system, we investigated the impact of autonomic nervous system-related factors on the cardiovascular response: a genetic polymorphism in the norepinephrine transporter and gender effects. Methods: Blood pressure and heart rate were monitored during and following administration of a subanesthetic dose of ketamine or placebo in 68 healthy participants (mean age 26.04 ±5.562 years) in a double-blind, randomized, controlled, parallel-design trial. The influences of baseline blood pressure/heart rate, gender, and of a polymorphism in the norepinephrine transporter gene (NET SLC6A2, rs28386840 [A-3081T]) on blood pressure and heart rate changes were investigated. To quantify changes in blood pressure and heart rate, we calculated the maximum change from baseline (ΔMAX) and the time until maximum change (TΔMAX). Results: Systolic and diastolic blood pressure as well as heart rate increased significantly upon ketamine administration, but without reaching hypertensive levels. During administration, the systolic blood pressure at baseline (TP0Sys) correlated negatively with the time to achieve maximal systolic blood pressure (TΔMAXSys, P<.001). Furthermore, women showed higher maximal diastolic blood pressure change (ΔMAXDia, P<.001) and reached this peak earlier than men (TΔMAXDia, P=.017) at administration. NET rs28386840 [T] carriers reached their maximal systolic blood pressure during ketamine administration significantly earlier than [A] homozygous (TΔMAXSys, P=.030). In a combined regression model, both genetic polymorphism and TP0Sys were significant predictors of TΔMAXSys (P<.0005). Conclusions: Subanesthetic ketamine increased both blood pressure and heart rate without causing hypertensive events. Furthermore, we identified gender and NET rs28386840 genotype as factors that predict increased cardiovascular sequelae of ketamine administration in our young, healthy study population providing a potential basis for establishing monitoring guidelines.

EUDOR-A multi-centre research program: A naturalistic, European Multi-centre Clinical study of EDOR Test in adult patients with primary depression.

BACKGROUND: Electrodermal reactivity has been successfully used as indicator of interest, curiosity as well as depressive states. The measured reactivity depends on the quantity of sweat secreted by those eccrine sweat glands that are located in the hypodermis of palmar and plantar regions. Electrodermal hyporeactive individuals are those who show an unusual rapid habituation to identical non-significant stimuli. Previous findings suggested that electrodermal hyporeactivity has a high sensitivity and a high specificity for suicide. The aims of the present study are to test the effectiveness and the usefulness of the EDOR (ElectroDermal Orienting Reactivity) Test as a support in the suicide risk assessment of depressed patients and to assess the predictive value of electrodermal hyporeactivity, measured through the EDOR Test, for suicide and suicide attempt in adult patients with a primary diagnosis of depression. METHODS AND DESIGN: 1573 patients with a primary diagnosis of depression, whether currently depressed or in remission, have been recruited at 15 centres in 9 different European countries. Depressive symptomatology was evaluated through the Montgomery-Asberg Depression Scale. Previous suicide attempts were registered and the suicide intent of the worst attempt was rated according to the first eight items of the Beck Suicide Intent Scale. The suicide risk was also assessed according to rules and traditions at the centre. The EDOR Test was finally performed. During the EDOR Test, two fingers are put on gold electrodes and direct current of 0.5 V is passed through the epidermis of the fingers according to standards. A moderately strong tone is presented through headphones now and then during the test. The electrodermal responses to the stimuli represent an increase in the conductance due to the increased number of filled sweat ducts that act as conductors through the electrically highly resistant epidermis. Each patient is followed up for one year in order to assess the occurrence of intentional self-harm. DISCUSSION: Based on previous studies, expected results would be that patients realizing a suicide attempt with a strong intent or committing suicide should be electrodermally hyporeactive in most cases and non-hyporeactive patients should show only few indications of death intent or suicides. TRIAL REGISTRATION: The German Clinical Trials Register, DRKS00010082 . Registered May 31st, 2016. Retrospectively registered.