Prevalence and influencing factors of chronic post-traumatic stress disorder in patients with myocardial infarction, transient ischemic attack (TIA) and stroke - an exploratory, descriptive study.

BACKGROUND: Cardio- and cerebrovascular events such as myocardial infarction (MI), stroke and transient ischemic attack (TIA) are leading causes of death and disability and have also been associated with poor mental outcomes. In addition, cardio- and cerebrovascular events may pose the risk of experiencing a sudden traumatic occurrence of symptoms during ictus and thus contribute to high rates of PTSD as well as high rates of subsequent depression and anxiety. Moreover, MI, TIA and stroke survivors with PTSD, depressive and anxiety symptoms may have poorer health-related quality of life (HRQoL) and poorer disease prognosis than patients who do not develop psychiatric symptoms after ictus. However, data on the prevalence of PTSD, anxiety and depression, as well as the HRQoL, coping strategies and potential risk factors for development of PTSD in these patients, are rare. METHODS: In an exploratory, descriptive study we interviewed 112 patients (54 MI, 18 TIA, 40 stroke; mean age: 69.5 years, 55.4% males) from three general physician practices and used psychometric self-assessment tools to determine the occurrence of PTSD and psychosomatic comorbidity, anxiety and depression and to assess HRQoL and coping strategies. We evaluated disease severity and compared the patient groups to each other. Moreover, we assessed psychological outcome differences between patients with or without PTSD after ictus. RESULTS: The prevalence of PTSD after MI, TIA and stroke was 23.2%. The patients who developed PTSD had higher rates of depression, anxiety and maladaptive coping as well as reduced HRQoL. Adaptive coping was positively related to better mental HRQoL and negatively related to anxiety and depression. Disease severity of MI, TIA and stroke was not related to PTSD, depression, anxiety or physical HRQoL. CONCLUSIONS: Experiencing MI, TIA or stroke means confronting a life-threatening event for those affected and, therefore, these can be regarded as traumatic events. Cerebral and cardiovascular events increase the risk of developing chronic PTSD with subsequent increased depression and anxiety and reduced HRQoL. These findings emphasize the need for early screening and diagnosis of PTSD in somatically ill patients, which should be followed by specialized treatment, as PTSD hampers overall (somatic) disease prognosis. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00021730, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00021730 , registered 05/19/2020 - Retrospectively registered.

Occurence of Post-Traumatic Stress Symptoms, Anxiety and Depression in the Acute Phase of Transient Ischemic Attack and Stroke.

Rates of post-traumatic stress symptoms, anxiety and depression are increased in patients having experienced a transient ischemic attack (TIA) or stroke several months ago. However, data of psychiatric symptoms in the acute phase within the first days after ictus are lacking. In 20 patients with stroke and 33 patients with TIA we assessed disease severity by means of the NIHSS, levels of depression and anxiety by HADS, PTSD-like symptoms by PC-PTSD, quality of life (HrQoL) by SF-12, and coping style by brief COPE Inventory within the first 5 days after ictus. NIHSS on admission was lower in patients with TIA (0 ± 1) than in patients with stroke (3 ± 2, p < 0.001). HADS depression score was significantly higher in patients with stroke (7.0 ± 4.5) than in patients with TIA (4.9 ± 4.0). HADS anxiety score, HrQoL and coping styles were similar between TIA and stroke patients (p > 0.05). 5 and 3 of 33 TIA patients as well as 4 and 3 of 20 stroke patients had at least 11 points in the HADS anxiety and depression score respectively (p = 0.001). 2 of 33 TIA patients and 2 of 20 stroke patients had more than 2 points in the PC-PTSD (p = 0.646). We did not find consistent correlations between the NIHSS and the psychometric parameters. Within the first five days after patients having experienced a TIA or stroke PTSD-like, anxious and depressive symptoms are more common than in the general population. As the acute psychological status after ictus is predictive for psychiatric comorbidity years later physicians should pay attention and adequately treat psychiatric symptoms already in the acute phase of stroke.Trial Registration: German Clinical Trials Register, DRKS00021730, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00021730 , registered 05/19/2020- Retrospectively registered.

Safety Profile of Methylphenidate Under Long-Term Treatment in Adult ADHD Patients - Results of the COMPAS Study.

INTRODUCTION: The Comparison of Methylphenidate and Psychotherapy in adult ADHD Study (COMPAS) was a prospective, randomized multicenter clinical trial, comparing methylphenidate (MPH) with placebo (PLAC) in combination with cognitive behavioral group psychotherapy (GPT) or individual clinical management (CM) over the period of 1 year. Here, we report results on treatment safety. METHODS: MPH and PLAC were flexibly dosed. Among 433 randomized patients, adverse events (AEs) were documented and analyzed on an "as received" basis during week 0-52. Electrocardiogram data were recorded at baseline and week 24. RESULTS: Comparing 205 patients who received ≥1 dose of MPH with 209 patients who received PLAC, AEs occurring significantly more frequently in the MPH group were decreased appetite (22 vs. 3.8%), dry mouth (15 vs. 4.8%), palpitations (13 vs. 3.3%), gastrointestinal infection (11 vs. 4.8%), agitation (11 vs. 3.3%), restlessness (10 vs. 2.9%), hyperhidrosis, tachycardia, weight decrease (all 6.3 vs. 1.9%), depressive symptom, influenza (both 4.9 vs. 1.0%), and acute tonsillitis (4.4 vs. 0.5%). Syncope occurred significantly more often in the PLAC group (2.4 vs. 0%). Clinically relevant ECG changes occurred very rarely in both groups. Serious AEs were rare and without a significant group difference. The comparison of 206 patients treated with GPT versus 209 patients who received CM revealed no major differences. Serious AE classified as psychiatric occurred in 5 cases in the CM group and in 1 case in the GPT group. CONCLUSION: In this so far longest-running clinical trial, methylphenidate treatment was safe and well-tolerated.

Update on structured pain assessment for the documentation of diagnosis-independent symptoms and signs associated with pain.

Concerning the diagnosis and therapy of pain syndromes, standardized descriptions similar to those used in the examination of psychopathological findings via the system produced by the AMDP ("Arbeitsgemeinschaft für Methodik und Dokumentation in der Psychiatrie", i. e., the working group establishing standardized methodology and documentation within psychiatry) are still lacking. Therefore, the authors of this article have founded a working group to establish standardized methodology and documentation for symptoms and signs associated with pain, although not at a diagnosis-specific level, in order to promote standardization in the documentation of pain and rating of the symptoms associated with a given set of medical results. This article presents a system for documenting the symptoms and signs associated with pain globally and independently of the diagnosis (Structured Pain Assessment System) with nomenclature that is inspired by the AMDP system. The objective of this working group is to develop documentation for a uniform multidimensional pain assessment (with defined terminology) that serves as a comparable and unified standard in the field.

Hyperactivity/restlessness is associated with increased functional connectivity in adults with ADHD: a dimensional analysis of resting state fMRI.

BACKGROUND: Adult attention-deficit/hyperactivity disorder (ADHD) is a serious and frequent psychiatric disorder of multifactorial pathogenesis. Several lines of evidence support the idea that ADHD is, in its core, a disorder of dysfunctional brain connectivity within and between several neurofunctional networks. The primary aim of this study was to investigate associations between the functional connectivity within resting state brain networks and the individual severity of core ADHD symptoms (inattention, hyperactivity, and impulsivity). METHODS: Resting state functional magnetic resonance imaging (rs-fMRI) data of 38 methylphenidate-naïve adults with childhood-onset ADHD (20 women, mean age 40.5 years) were analyzed using independent component analysis (FSL's MELODIC) and FSL's dual regression technique. For motion correction, standard volume-realignment followed by independent component analysis-based automatic removal of motion artifacts (FSL's ICA-AROMA) were employed. To identify well-established brain networks, the independent components found in the ADHD group were correlated with brain networks previously found in healthy participants (Smith et al. PNAS 2009;106:13040-5). To investigate associations between functional connectivity and individual symptom severity, sex, and age, linear regressions were performed. RESULTS: Decomposition of resting state brain activity of adults with ADHD resulted in similar resting state networks as previously described for healthy adults. No significant differences in functional connectivity were seen between women and men. Advanced age was associated with decreased functional connectivity in parts of the bilateral cingulate and paracingulate cortex within the executive control network. More severe hyperactivity was associated with increased functional connectivity in the left putamen, right caudate nucleus, right central operculum and a portion of the right postcentral gyrus within the auditory/sensorimotor network. CONCLUSIONS: The present study supports and extends our knowledge on the involvement of the striatum in the pathophysiology of ADHD, in particular, in the pathogenesis of hyperactivity. Our results emphasize the usefulness of dimensional analyses in the study of ADHD, a highly heterogeneous disorder. TRIAL REGISTRATION: ISRCTN12722296 ( https://doi.org/10.1186/ISRCTN12722296 ).

Off-label prescription of psychiatric drugs by non-psychiatrist physicians in three general hospitals in Germany.

BACKGROUND: Off-label prescribing of psychoactive drugs is a common practice in psychiatry. Here, we sought to investigate the frequency of off-label prescribing in a population of hospitalized patients with a somatic illness who were also suffering from a psychiatric pathology. METHODS: Using a prospective, observational design, we collected data from 982 hospitalized patients with a somatic illness for whom a psychiatric consultation was requested because of the presence of additional psychiatric symptoms. Data were collected at three hospitals in Germany. Demographic and clinical data, including the previous psychoactive medications and an assessment of the suitability of the previous medications, were recorded and analyzed. RESULTS: Data on the previous psychiatric medications were available for 972 patients. In 16.6% of patients, at least one psychoactive drug had been prescribed off-label, 20.2% had received on-label medication, and 63.2% had not received any psychiatric medication. Among all patients receiving psychiatric medication, 45.1% had received off-label medication. The logistic regression analysis showed a significant influence of age on the likelihood of receiving off-label medication (p = 0.018). Benzodiazepines were the most frequent off-label prescription (25.8% of off-label prescriptions), followed by atypical antipsychotics (18.2%) and low-potency antipsychotics (17.2%). Notably, 57.1% of off-label prescriptions were judged to be 'not indicated' by experienced psychiatrists. CONCLUSIONS: Our data show a high frequency of the off-label prescription of psychoactive drugs by physicians treating patients with somatic illnesses in general hospitals. Because more than half of these cases were judged to be "not indicated", these prescriptions indicate a potential risk to patients. Furthermore, the classes of drugs that were most frequently prescribed off-label, benzodiazepines and antipsychotics, both show a substantial risk profile, particularly for elderly patients.

Synthetic Cannabinoid Use in a Psychiatric Patient Population: A Pilot Study.

BACKGROUND: Consumption of natural cannabis (NC) and synthetic cannabinoids (SCs) has been associated with psychotic disorders. We compared the prevalence of use, consumer profiles, and psychosis-inducing potential of NC and SCs in a specific high-risk population. METHODS: This prospective pilot study included 332 patients (18-64 years, mean 36.83, SD 13.33). Patients' sociodemographics and medical histories as well as illicit substance use and psychiatric symptom histories were collected using a drug consumption survey that assessed the use of new psychoactive substances and the Psychotic Symptoms Interview. RESULTS: In total, 7.2% of all patients, 10.6% of psychotic patients, and 4.5% of nonpsychotic patients reported SC consumption. Compared with SCs, NC was consumed much more frequently by its users (mean 222.73, SD 498.27). NC and SC use induced persistent psychosis. Psychotic symptoms were first experienced by patients with a history of NC or SC use during intoxication and persisted after cessation (>1 year) of drug use. Positive and negative symptoms tended to be more severe in SC and NC users, respectively. CONCLUSIONS: NC and SCs may cause different symptom clusters. These relationships should be further evaluated.

[The AMDS system for the documentation of symptoms and signs associated with pain]. / Das AMDS-System zur Dokumentation von Schmerzbefunden.

The authors present a system for nomenclature and documentation of symptoms and signs associated with pain. The system was compiled in a staged process by the study group for methods and documentation of pain-associated symptoms and signs (Arbeitsgemeinschaft für Methodik und Dokumentation von Schmerzbefunden [AMDS]). The suggested items were elaborated from terms used in current national and international guidelines and classifications and in part integrated into superordinate terms. The items that were built up by this approach aim to reflect the broad spectrum of pain diseases. The items for the description of pain-associated symptoms and signs are divided into the areas of algesiomotor, psychoalgesiological and somatoalgesiological findings. The aim is the documentation of a multidimensional algesiological description of findings with defined terminology, which can serve as a comparable and unified standard, particularly in the field of pain assessment. The AMDS system should enable a systematic description of pain, which is a reliable foundation for diagnostics, therapy planning and expert case evaluation.

Decline in Psychotic Symptoms in Addition to Cardiac and Metabolic Safety with Cariprazine After Poor Response to Previous Antipsychotic Treatments - A Series of Two Cases.

Cariprazine is a highly effective antipsychotic medication of the latest generation. Due to its special receptor profile with D2/D3 partial agonism and high D3 affinity, the use of cariprazine is particularly justified in negative psychotic symptomatic and cardiac prestressed patients or in patients with weight management problems. In this case series, two cases and the outcomes during the switch to cariprazine treatment under these conditions are described.

Physical exercise in attention deficit hyperactivity disorder - evidence and implications for the treatment of borderline personality disorder.

A growing body of literature indicates a potential role for physical exercise in the treatment of attention deficit hyperactivity disorder (ADHD). Suggested effects include the reduction of ADHD core symptoms as well as improvements in executive functions. In the current review, we provide a short overview on the neurophysiological mechanisms assumed to underlie the beneficial effects of exercise. Further, we review the current evidence from experimental studies regarding both acute exercise and long-term interventions in ADHD. While the positive effects observed after acute aerobic exercise are promising, very few well-designed long-term intervention studies have been conducted yet. Moreover, although exercise effects have not yet been studied in borderline personality disorder (BPD), in the end of this paper we derive hypotheses why exercise could also be beneficial for this patient population.

Aggravation of symptom severity in adult attention-deficit/hyperactivity disorder by latent Toxoplasma gondii infection: a case-control study.

Toxoplasma gondii (T. gondii) has a high worldwide prevalence and an underestimated impact on neuropsychiatric disorders. Previous studies related T. gondii to disorders associated with the dysfunctional dopaminergic system. However, an association between T. gondii infection and adult attention-deficit/hyperactivity disorder (ADHD) has not yet been studied. In a sex- and age-matched case-control study, we investigated the seropositivity, serointensity, and avidity of latent T. gondii infection in adult ADHD patients and examined the influence of those variables on the symptomatology of ADHD. Of 140 participants, 20.0% were seropositive for anti-T. gondii IgG and 0% for anti-T. gondii IgM. T. gondii seropositivity was associated with 2.8-fold increase in the odds of ADHD in a confounder-adjusted multivariable analysis. Age and consumption of raw/undercooked meat were confirmed as significant predictors of T. gondii seropositivity. Multiple linear regression analysis of self-rated ADHD-related symptom severity in all participants revealed a significant association with T. gondii seropositivity, elevated IgG titers (serointensity), and stronger anti-T. gondii IgG avidity. Overall symptom severity was increased in seropositive ADHD patients compared to seronegative subjects with ADHD. In particular, hyperactivity was significantly associated with serointensity. We conclude that there is a high rate of T. gondii seropositivity in adults with ADHD. Additionally, our results suggest a clinical impact of latent T. gondii infection on ADHD-related symptoms in a serointensity- and avidity-dependent manner.

Kidney-transplant patients receiving living- or dead-donor organs have similar psychological outcomes (findings from the PI-KT study).

PURPOSE: Kidney transplantation (KT) is the treatment of choice for end-stage chronic kidney disease (CKD) and is well known to improve the clinical outcome of patients. However, the impact of KT on comorbid psychological symptoms, particularly depression and anxiety, is less clear, and recipients of living-donor (LD) organs may have a different psychological outcome from recipients of dead-donor (DD) organs. DESIGN/METHODOLOGY/APPROACH: In total, 152 patients were included and analyzed using a cross-sectional design. Of these patients, 25 were pre-KT, 13 were post-KT with a LD transplant and 114 were post-KT with a DD transplant. The patients were tested for a variety of psychometric outcomes using the Hospital Anxiety and Depression Scale, the 12-Item Short Form Health Survey (assessing physical and mental health-related quality of life), the Resilience Scale, the Coping Self-Questionnaire and the Social Support Questionnaire. FINDINGS: The mean age of the patients was 51.25 years and 40 per cent of the patients were female. As expected, the post-KT patients had significantly better scores on the physical component of the Short Form Health Survey than the pre-KT patients, and there were no significant differences between the two post-KT groups. There were no significant differences among the groups in any of the other psychometric outcome parameters tested, including anxiety, depression and the mental component of health-related quality of life. RESEARCH LIMITATIONS/IMPLICATIONS: KT and the origin of the donor organ do not appear to have a significant impact on the psychological well-being of transplant patients with CKD. Although the diagnosis and early treatment of psychological symptoms, such as depression and anxiety, remain important for these patients, decisions regarding KT, including the mode of transplantation, should not be fundamentally influenced by concerns about psychological impairments at the population level. ORIGINALITY/VALUE: CKD is a serious condition involving profound impairment of the physical and psychological well-being of patients. KT is considered the treatment of choice for most of these patients. KT has notable advantages over dialysis with regard to the long-term physical functioning of the renal and cardiovascular system and increases the life expectancy of patients. However, the data on the improvement of psychological impairments after KT are less conclusive.

Rapid titration protocol - Experiences with a dynamic novel titration regime for vagus nerve stimulation in a group of depressive patients.

Vagus nerve stimulation (VNS) is an established tool in the psychiatric armamentarium for patients with therapy-resistant depression (TRD) with response rates of approximately 60%. So far, VNS is titrated slowly during ambulatory in-office visits. Thus, antidepressive effects can be expected after approximately six months. We report our experiences with a rapid dosing regime (RDR) with titration start shortly after VNS-implantation. We retrospectively analysed data of six patients with TRD who received VNS. Stimulation parameters were evaluated with regard to clinical side effects, heart rates (HR) and blood pressures (BP). Depressive symptoms were measured by Montgomery-Asberg Depression Rating Scale (MADRS) one week before and three months after implantation of the VNS. All patients received first stimulation between one and four days after surgery. We elevated output current using 0.25 mA titration steps. We increased output current between one and four days after the last titration. All patients received 1.0 mA output current after eight to 14 days post-surgery. HR and BP remained stable in all patients. All side effects were mild and temporary. MADRS scores were significantly lower three months after VNS-implantation (24 ±â€¯8) than one week before VNS-implantation (42 ±â€¯4; p = 0.028). The therapeutic range of VNS-parameters for antidepressive effect was reached quicker without finding increased numbers of side effects. Consequently, by using RDR the antidepressive effect of VNS-therapy for patients with TRD could be reached earlier than using slow titration. Our presented RDR might be able to significantly shorten the "clinical effect gap" due to the neurobiological and titration-related latency.

[Coercive Measures in Psychiatry - Even if Carried out lege artis Pose a Risk for Complications or Harm]. / Zwangsmaßnahmen in der Psychiatrie ­ Auch lege artis durchgeführt besteht ein Risiko für Komplikationen.

Coercive measures in psychiatry are used as a last resort if other means to avert imminent danger failed. Our case shows, that even if all precautions were taken complications may arise: We report about a young man, who had been restrained. After the belts had been partly loosened, he again became extremely aggressive. When the restraints had to be tightened he could grab and swallow the Segufix®-Metal Pin.

Acute Effects of Aerobic Exercise on Executive Function and Attention in Adult Patients With ADHD.

Aerobic exercise can improve cognitive functions in healthy individuals and in various clinical groups, which might be particularly relevant for patients with ADHD. This study investigated the effects of a single bout of aerobic exercise on attention and executive functions in adult patients with ADHD, including functional MRI to examine the underlying neural mechanisms. On two different days, 23 adult patients with ADHD and 23 matched healthy controls performed in a flanker task, while functional MR images were collected, following 30 min of continuous stationary cycling with moderate intensity as well as after a control condition (watching a movie). Behavioral performance and brain activation were tested for differences between groups and conditions and for interactions to investigate whether exercise improves executive function to a greater extent in patients compared to healthy controls. Exercise significantly improved reaction times in congruent and incongruent trials of the flanker task in patients with ADHD but not in healthy controls. We found no changes in brain activation between the two conditions for either group. However, a subgroup analysis of ADHD patients with a higher degree of cardiorespiratory fitness revealed decreased activation in premotor areas during congruent trials and in premotor and medial frontal cortex during incongruent trials in the exercise compared to the control condition. Our results indicate exercise-induced improvements in attention and processing speed in patients with ADHD, demonstrating that adult patients with ADHD may benefit from an acute bout of exercise. These findings could be of high relevance for developing alternative treatment approaches for ADHD. In addition, results of the current study contribute to elucidate the neurophysiological mechanisms underlying the beneficial effects of exercise on cognition and to better understand the role of cardiorespiratory fitness on these effects.

Exploring Self-Paced Embodiable Neurofeedback for Post-stroke Motor Rehabilitation.

Neurofeedback-guided motor-imagery training (NF-MIT) has been proposed as a promising intervention following upper limb motor impairment. In this intervention, paretic stroke patients receive online feedback about their brain activity while conducting a motor-imagery (MI) task with the paretic limb. Typically, the feedback provided in NF-MIT protocols is an abstract visual signal based on a fixed trial. Here we developed a self-paced NF-MIT paradigm with an embodiable feedback signal (EFS), which was designed to resemble the content of the mental act as closely as possible. To this end, the feedback was delivered via an embodiable, anthropomorphic robotic hand (RH), which was integrated into a closed-looped EEG-based brain-computer interface (BCI). Whenever the BCI identified a new instance of a hand-flexion or hand-extension imagination by the participant, the RH carried out the corresponding movement with minimum delay. Nine stroke patients and nine healthy participants were instructed to control RH movements as accurately as possible, using mental activity alone. We evaluated the general feasibility of our paradigm on electrophysiological, subjective and performance levels. Regarding electrophysiological measures, individuals showed the predicted event-related desynchronization (ERD) patterns over sensorimotor brain areas. On the subjective level, we found that most individuals integrated the RH into their body scheme. With respect to RH control, none of our participants achieved a high level of control, but most managed to control the RH actions to some degree. Importantly, patients and controls achieved similar performance levels. The results support the view that self-paced embodiable NF-MIT is feasible for stroke patients and can complement classical NF-MIT.

Effects of nature-based mindfulness training on resilience/symptom load in professionals with high work-related stress-levels: findings from the WIN-Study.

PURPOSE: The levels of work-related stress and the incidence rates of subsequent related illnesses are increasing in our society, leading to high individual and socioeconomic burdens. Mindfulness training has been shown to be an effective method of improving stress resilience. This paper aims to investigate the efficacy of nature-based mindfulness training in professionals with high levels of work-related stress. DESIGN/METHODOLOGY/APPROACH: In this controlled pilot study, a total of 56 volunteers completed a nature-based mindfulness training progam and were compared to 8 participants (waitlist controls). Psychometric assessments were performed at baseline and after two and four months of training. FINDINGS: After two months of training, the scores for self-efficacy, sense of coherence, level of mindfulness and overall psychiatric symptom load had significantly improved in the intervention group, while the control group did not show any significant improvements. A comparison between the intervention and control groups showed a significant difference regarding the sense of coherence only. RESEARCH LIMITATIONS/IMPLICATIONS: Since this was an exploratory study with a small control group, further studies are needed to verify our findings. PRACTICAL IMPLICATIONS: In conclusion, nature-based mindfulness training seems to be a promising tool for the improvement of resilience and overall psychological health in professionals. ORIGINALITY/VALUE: This was the first study to systematically investigate effects of nature-based mindfulness training in people with high work-related stress.

Vagus Nerve Stimulation As an Adjunctive Neurostimulation Tool in Treatment-resistant Depression.

Vagus nerve stimulation (VNS) is an approved neurostimulation therapy. The purpose of the method is to treat patients with therapy-resistant depression (TRD). VNS exhibits antidepressive and stabilizing effects. This method is particularly useful as a long-term treatment, in which up to two-thirds of patients respond. The vagus nerve stimulator is positioned on the left vagus nerve during a surgical procedure and is activated telemetrically by a wand connected to a handheld computerized device. The treating physician can perform various adjustments of the vagus nerve stimulator during in-office visits (e.g., by modifying stimulation intensity or stimulation frequency) to achieve maximum therapeutic effects with low side effects. Set-up of the device usually takes several months. Typical side effects include wound infection, temporary salivation, coughing, paralysis of the vocal cords, bradycardia, or even asystole. The patient can stop the VNS by placing a magnet over the generator. The current protocol describes delivery of the specific stimulation tool and methods for adjusting the tuning parameters to achieve the best remission rates in patients with TRD.

Long-term Effects of Multimodal Treatment on Adult Attention-Deficit/Hyperactivity Disorder Symptoms: Follow-up Analysis of the COMPAS Trial.

Importance: Knowledge about the long-term effects of multimodal treatment in adult attention-deficit/hyperactivity disorder (ADHD) is much needed. Objective: To evaluate the long-term efficacy of multimodal treatment for adult ADHD. Design, Setting, and Participants: This observer-masked, 1.5-year follow-up of the Comparison of Methylphenidate and Psychotherapy in Adult ADHD Study (COMPAS), a prospective, multicenter randomized clinical trial, compared cognitive behavioral group psychotherapy (GPT) with individual clinical management (CM) and methylphenidate (MPH) with placebo (2 × 2 factorial design). Recruitment started January 2007 and ended August 2010, and treatments were finalized in August 2011 with follow-up through March 2013. Overall, 433 adults with ADHD participated in the trial, and 256 (59.1%) participated in the follow-up assessment. Analysis began in November 2013 and was completed in February 2018. Interventions: After 1-year treatment with GPT or CM and MPH or placebo, no further treatment restrictions were imposed. Main Outcomes and Measures: The primary outcome was change in the observer-masked ADHD Index of Conners Adult ADHD Rating Scale score from baseline to follow-up. Secondary outcomes included further ADHD rating scale scores, observer-masked ratings of the Clinical Global Impression scale, and self-ratings of depression on the Beck Depression Inventory. Results: At follow-up, 256 of 433 randomized patients (baseline measured in 419 individuals) participated. Of the 256 patients participating in follow-up, the observer-masked ADHD Index of Conners Adult ADHD Rating Scale score was assessed for 251; the mean (SD) baseline age was 36.3 (10.1) years; 125 patients (49.8%) were men; and the sample was well-balanced with respect to prior randomization (GPT and MPH: 64 of 107; GPT and placebo: 67 of 109; CM and MPH: 70 of 110; and CM and placebo: 55 of 107). At baseline, the all-group mean ADHD Index of Conners Adult ADHD Rating Scale score was 20.6, which improved to adjusted means of 14.2 for the GPT arm and 14.7 for the CM arm at follow-up with no significant difference between groups (difference, -0.5; 95% CI, -1.9 to 0.9; P = .48). The adjusted mean decreased to 13.8 for the MPH arm and 15.2 for the placebo arm (difference, -1.4; 95% CI, -2.8 to -0.1; P = .04). As in the core study, MPH was associated with a larger reduction in symptoms than placebo at follow-up. These results remained unchanged when accounting for MPH intake at follow-up. Compared with participants in the CM arm, patients who participated in group psychotherapy were associated with less severe symptoms as measured by the self-reported ADHD Symptoms Total Score according to the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) (DSM-IV) of Conners Adult ADHD Rating Scale (AMD, -2.1; 95% CI, -4.2 to -0.1; P = .04) and in the subscale of reducing pure hyperactive symptoms, measured via the Diagnostic Checklist for the diagnosis of ADHD in adults (AMD, -1.3; 95% CI, -2.8 to 0.1; P = .08). Regarding the Clinical Global Impression scale assessment of effectiveness, the difference between GPT and CM remained significant at follow-up (odds ratio, 1.63; 95% CI, 1.03-2.59; P = .04). No differences were found for any comparison concerning depression as measured with the Beck Depression Inventory. Conclusions and Relevance: Results from COMPAS demonstrate a maintained improvement in ADHD symptoms for adults 1.5 years after the end of a 52-week controlled multimodal treatment period. The results indicate that MPH treatment combined with GPT or CM provides a benefit lasting 1.5 years. Confirming the results of the core study, GPT was not associated with better results regarding the primary outcome compared with CM. Trial Registration: isrctn.org Identifier: ISRCTN54096201.

Impact of bariatric surgery on neural food processing and cognition: an fMRI study.

INTRODUCTION: The Roux-en-Y gastric bypass (RYGB) is one of the most widely used techniques for bariatric surgery. After RYGB, weight loss up to 50%-70% of excess body weight, improvement of insulin-resistance, changes in food preferences and improvements in cognitive performance have been reported. This protocol describes a longitudinal study of the neural correlates associated with food-processing and cognitive performance in patients with morbid obesity before and after RYGB relative to lean controls. METHODS AND ANALYSIS: This study is a pre-post case-control experiment. Using functional MRI, the neural responses to food stimuli and a working memory task will be compared between 25 patients with obesity, pre and post RYGB, and a matched, lean control group. Resting state fMRI will be measured to investigate functional brain connectivity. Baseline measurements for both groups will take place 4 weeks prior to RYGB and 12 months after RYGB. The effects of RYGB on peptide tyrosine tyrosine and glucagon-like polypeptide-1 will also be determined. ETHICS AND DISSEMINATION: The project has received ethical approval by the local medical ethics committee of the Carl-von-Ossietzky University of Oldenburg, Germany (registration: 2017-073). Results will be published in a peer-reviewed journal as original research and on international conferences. TRIAL REGISTRATION NUMBER: DRKS00012495; Pre-results.