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Although well-studied in children, MPH is not approved for the treatment of ADHD in adults in Germany. We report the findings from the German subgroup of the European LAMDA trial.
Patients (18-65 years) with ADHD (DSM-IV) were treated in this 5-week double-blind, randomized, placebo-controlled, fixed dose trial with 18, 36, 72-mg/day OROS-MPH or placebo. Eligible patients continued into the subsequent 7-week open-label extension-phase starting with 18 mg/day OROS-MPH.
108 patients entered the double-blind phase, which was completed by 89.9%. the open-label phase was completed by 92.6%. Concerning CAARS:O-SV total scores (LOCF), mean changes from baseline to double-blind endpoint in were -9.6±10.6 (18-mg), -13.3±10.3 (36-mg) and -12.7±10.7 (72-mg) vs. -8.2±8.4 (placebo group). Mean changes from start of open-label phase to endpoint were -17.5 in patients who received OROS-MPH and -16.5, who received placebo in double-blind phase. Mean Q-LES-Q-SF scores (health-related QoL) improved from baseline in all treatment groups in the double-blind phase, and continued to improve in the open-label phase. AE occurred in 77.4% (18-mg), 85.7% (36-mg), 77.4% (72-mg) and 65.5% (placebo group). Most common AE were decreased appetite, headache, nasopharyngitits and weight decreased. No statistically significant changes in mean blood pressure were observed in the double-blind or open-label phases. Mean pulse increased by 7.0 bpm (72-mg group) at week 5 (p=0.025) and by 7.9 bpm in all patients at week 12 (p< 0.001).
This analysis of the German subpopulation is in line with results of the full study, showing that OROS-MPH is effective and well tolerated in adults with ADHD.
Attention Deficit Hyperactivity Disorder (ADHD) is a serious risk factor for co-occurring psychiatric disorders and negative psychosocial consequences in adulthood. Given this background, there is great need for an effective treatment of adult ADHD patients.
Therefore, our research group has conducted a first controlled randomized multicenter study on the evaluation of disorder-tailored DBT-based group program in adult ADHD compared to a psychophar-macological treatment.
Between 2007 and 2010, in a four-arm-design 433 patients were randomized to a manualized dialectical behavioural therapy (DBT) based group program plus methylphenidate or placebo or clinical management plus methylphenidate or placebo with weekly sessions in the first twelve weeks and monthly sessions thereafter. Therapists are graduated psychologists or physicians. Treatment integrity is established by independent supervision. Primary endpoint (ADHD symptoms measured by the Conners Adult ADHD Rating Scale) is rated by interviewers blind to the treatment allocation (Current Controlled Trials ISRCTN54096201). The trial is funded by the German Federal Ministry of Research and Education (01GV0606) and is part of the German network for the treatment of ADHD in children and adults (ADHD-NET). In the lecture the first data of our interim analysis are presented (baseline data, results of treatment compliance and adherence).
In studies of adult patients with attention deficit hyperactivity disorder (ADHD) atomoxetine (ATX) has demonstrated substantial improvements in ADHD symptomatology using Conners’ Adult ADHD Rating Scales (CAARS). The pattern suggests incremental response over time with no clear plateau of response.
To identify patterns of response to ATX in adult ADHD patients and to describe those trajectories over time
To determine if patients have distinct response trajectories using CAARS in two populations, short term (12 weeks) and long term (24 weeks) treatment data.
Data from 2502 ATX patients, who had an investigator-rated CAARS total score at ≥ short or long term time point, The numbers of trajectory clusters for short term (n=2502) and long term (n=1139) data were identified using hierarchical clustering methods. Linear mixed modelling was used to describe those different trajectories over time.
Using CAARS total, 4 trajectory clusters were identified in short term treated patients and 5 in long term. Three out of 4 short term trajectory clusters (representing 84% of patients) and 4 out 5 long term (representing 96%) showed more successful trajectories. In general clusters with less improvement were those with the worst baseline CAARS and minimal initial improvement. Distinct trajectory patterns of response were found that were incremental over time in all clusters.
Adult ADHD patients receiving atomoxetine have individual trajectories of response that can be divided into 4 short term trajectories and 5 long term trajectories. Further analysis is ongoing to describe these cohorts.
To investigate effects of a 12-week treatment with atomoxetine (ATX) on driving performance in real traffic, driving-related neuropsychological performance tests and self-evaluation of driving in adult patients with ADHD compared to an untreated control group with ADHD.
Parallel group design with an ATX and a waiting list group. At baseline and endpoint patients were evaluated with a standardized on-road driving test (SDBO), a driving-related neuropsychological test battery (Act and React Test System [ART2020]), and subjective measures of driving performance (one-week driving diary, Driver Coping Questionnaire).
Forty-three of the 64 included patients completed the study (n = 22 ATX, n = 21 controls). Mean intervention period was 11.9 ± 3.0 weeks, mean daily ATX dosage was 71.6 ± 14.9 mg. At endpoint, 60.1% of patients treated with ATX and 0% of waiting list group had reduced ADHD symptoms by greater or equal to 30%. In SDBO, ATX group reduced driving errors in three of four driving performance categories (attention, P < 0.05; risk-related self-control, P < 0.005; driver skills, P < 0.001), number of driving errors remained stable in control group. At endpoint, 47.6% of control group and 18.2% of ATX group (P < 0.05) did not fulfil the driving fitness criteria according to German Guidelines (percentile rank less or equal to 16 in one or more subtests in ART2020). Total number of self-reported critical traffic situations decreased from 12.0 to 6.8 per week in ATX group (P < 0.05) and remained stable in controls by 9.3 and 9.9 at baseline and endpoint (ns). Coping strategies with stressful traffic situations did not change within both groups.
Our study provides first evidence that treatment with ATX improves driving performance in real traffic in adults with ADHD.
The aim of this analysis is to describe medication adherence, and treatment persistence, in adults with attention deficit/hyperactivity disorder (ADHD) treated for 24 weeks with extended release methylphenidate (MPH-ER). Additionally, patient-, disorder- and treatment-related factors associated with adherence and persistence will be identified.
Post-hoc analysis of the active treatment group of a placebo-controlled, randomised, 24 week trial with MPH-ER with univariate description and multiple logistic regression models and Hosmer and Lemeshow tests.
In the sample of 241 adults with ADHD (mean age of 35.2 ± 10.1 years), 9.4% of the patients were non-adherent, taking less than 80% of the dispensed medication. Factors associated with non-adherence included age < 25 years, education level lower than secondary education, lacking family history of ADHD, lower ADHD baseline severity and lower self- and observer-rated medication efficacy. Lacking family history of ADHD, lower education level and lower self-rated medication efficacy, predicted non-adherence with a prediction accuracy of 16%. Seventeen percent of the patients discontinued early with most discontinuing within the first five weeks of the MPH-ER titration phase. Mean persistence in the discontinuing group was 63.4 ± 49.4 days. Factors associated with discontinuation included male gender, lower education level, lacking family history of ADHD and lower self- and observer-rated medication efficacy. Treatment non-response, male gender and lower education level predicted treatment discontinuation with a prediction accuracy of 22.7%.
Male adults without relatives with ADHD, with lower educational level and lower self- and observer-rated medication efficacy, who are newly treated with MPH-ER, are at increased risk of non-adherence and treatment discontinuation. Patients are at increased risk of treatment discontinuation during the medication titration phase.
The German version of the Conners Adult ADHD Rating Scales (CAARS) has proven to show very high model fit in confirmative factor analyses with the established factors inattention/memory problems, hyperactivity/restlessness, impulsivity/emotional lability, and problems with self-concept in both large healthy control and ADHD patient samples. This study now presents data on the psychometric properties of the German CAARS-self-report (CAARS-S) and observer-report (CAARS-O) questionnaires.
CAARS-S/O and questions on sociodemographic variables were filled out by 466 patients with ADHD, 847 healthy control subjects that already participated in two prior studies, and a total of 896 observer data sets were available. Cronbach's-alpha was calculated to obtain internal reliability coefficients. Pearson correlations were performed to assess test-retest reliability, and concurrent, criterion, and discriminant validity. Receiver Operating Characteristics (ROC-analyses) were used to establish sensitivity and specificity for all subscales.
Coefficient alphas ranged from .74 to .95, and test-retest reliability from .85 to .92 for the CAARS-S, and from .65 to .85 for the CAARS-O. All CAARS subscales, except problems with self-concept correlated significantly with the Barrett Impulsiveness Scale (BIS), but not with the Wender Utah Rating Scale (WURS). Criterion validity was established with ADHD subtype and diagnosis based on DSM-IV criteria. Sensitivity and specificity were high for all four subscales.
The reported results confirm our previous study and show that the German CAARS-S/O do indeed represent a reliable and cross-culturally valid measure of current ADHD symptoms in adults.
Identifying patients’ risk of reacting with suicidal ideation (SI) to psychotherapy is an important clinical problem that calls for empirical verification.
Analysis of associations between patients’ initial neurotic personality dysfunctions not accompanied by SI and emergence of SI at the end of a course of intensive psychotherapy conducted in integrative approach with predominance of psychodynamic approach in a day hospital.
Neurotic Personality Questionnaire KON-2006 and Life Inventory were completed by 680 patients at the time of admission to a psychotherapeutic day hospital due to neurotic, behavioral or personality disorders. Symptom Checklist KO “O” as a source of information about emergence of SI was completed both at the admission and at the end of the treatment. Among 466 patients without SI at the admission, in 4% SI occurred at the end of the treatment.
A number of neurotic personality dysfunctions (demeanors declared) that significantly predisposed to SI emergence at the end of the treatment were found: physical aggression against close ones (P < 0.001), grandiose fantasies (P = 0.043), tendencies to resignation (P = 0.022) and resignation-related feeling of loss of life opportunities (P = 0.037), tendency to follow predominantly ones intuition (P = 0.035).
In patients who declared the above-mentioned demeanors increased risk of SI emergence than in others (10–30% vs. 4%) indicate that there are particular vulnerable areas of neurotic personality that require especially careful approach during intensive psychotherapy–dealing with those areas may result in distress or anxiety that may lead to SI.
Disclosure of interest
The authors have not supplied their declaration of competing interest.
The hypothalamus—pituitary—adrenal axis (HPA axis) dysregulation plays an important role in the pathophysiology of anxiety disorders. Salivary cortisol level is a useful indicator of HPA axis dysfunction.
Most data suggests elevated cortisol awakening response (CAR) in anxiety disorders, but there are studies indicating opposite pattern (flat CAR).
Goal of this study was to determine whether patients with anxiety and personality disorders show a specific daily cortisol patterns and weather this pattern changes after 12 weeks of intensive predominantly psychodynamic combined group and individual psychotherapy.
The studied population comprised 77 patients, mainly females (72.7%), with primary diagnosis of anxiety disorder 40.9% or personality disorder 59.1%. The Symptom Checklist “0” was used to assess the pre- and post-treatment levels of patients’ symptoms. Pre- and post-treatment cortisol levels were measured in three saliva samples collected during one day (at awakening, 30 min after awakening, at 22.00).
The obtained results were partly similar to previous research. We found four different daily CAR patterns: decreased (drop 30 min after awakening), flat (rise 0–49% 30 min after awakening), normal (rise 50–75% 30 min after awakening) and elevated (rise over 75% 30 min after awakening), two of them (flat and elevated) were considered as typical for anxiety disorders. Groups of CAR pattern differed significantly in the level of sleep symptoms, dysthymia symptoms and avoidance/dependency symptoms. The changes in the CAR pattern after psychotherapy were not significant.
Anxiety disorders and personality disorders are characterized by more than two specific daily salivary cortisol patterns.
Disclosure of interest
The authors have not supplied their declaration of competing interest.
Hyperprolactinemia is a common endocrinological disorder. Some data suggest that psychological factors (e.g. personality traits) may play a role in hyperprolactinemia genesis.
Increased prolactin level (PRL) is described as clinical observations in some patients, usually with a diagnosis of borderline personality disorder. In the international literature there is lack of broader description and information of clinical implications of this phenomenon.
The aim of the study is to evaluate the prevalence of hyperprolactinemia in patients with diagnoses F40-F69 according to ICD-10 and an evaluation of the changes in PRL after psychotherapy.
The study population comprised 64 patients, mainly females (73%), with primary diagnosis of neurotic or personality disorder. Prolactin level was measured during the first and last week of the psychotherapy. Between the measurements patients underwent intensive short-term (12 weeks) group psychotherapy in a day hospital for neurotic and behavioural disorders.
Hyperprolactinemia was found in 41% of males and 42.4% of females in the study group. After psychotherapy significant reduction in prolactin level was observed in 80% of woman with hyperprolactinemia.
Hyperprolactinemia is observed in almost 40% of patients with neurotic and personality disorders. Psychodynamic psychotherapy can be a significant factor improving PRL level in patients with neurotic and personality disorders, specifically women.
Disclosure of interest
The authors have not supplied their declaration of competing interest.
Background Attention-deficit/hyperactivity disorder (ADHD) is among the most common psychiatric disorders of childhood that often persists into adulthood and old age. Yet ADHD is currently underdiagnosed and undertreated in many European countries, leading to chronicity of symptoms and impairment, due to lack of, or ineffective treatment, and higher costs of illness.
Methods The European Network Adult ADHD and the Section for Neurodevelopmental Disorders Across the Lifespan (NDAL) of the European Psychiatric Association (EPA), aim to increase awareness and knowledge of adult ADHD in and outside Europe. This Updated European Consensus Statement aims to support clinicians with research evidence and clinical experience from 63 experts of European and other countries in which ADHD in adults is recognized and treated.
Results Besides reviewing the latest research on prevalence, persistence, genetics and neurobiology of ADHD, three major questions are addressed: (1) What is the clinical picture of ADHD in adults? (2) How should ADHD be properly diagnosed in adults? (3) How should adult ADHDbe effectively treated?
Conclusions ADHD often presents as a lifelong impairing condition. The stigma surrounding ADHD, mainly due to lack of knowledge, increases the suffering of patients. Education on the lifespan perspective, diagnostic assessment, and treatment of ADHD must increase for students of general and mental health, and for psychiatry professionals. Instruments for screening and diagnosis of ADHD in adults are available, as are effective evidence-based treatments for ADHD and its negative outcomes. More research is needed on gender differences, and in older adults with ADHD.
Atomoxetine is a well-established pharmacotherapy for adult ADHD. Long-term studies show incremental reductions in symptoms over time. However, clinical experience suggests that patients differ in their response patterns.
From 13 Eli Lilly-sponsored studies, we pooled and analyzed data for adults with ADHD who completed atomoxetine treatment at long-term (24 weeks; n = 1443) and/or short-term (12 weeks; n = 2830) time-points, and had CAARS-Inv:SV total and CGI-S data up to or after these time-points and at Week 0 (i.e. at baseline, when patients first received atomoxetine). The goal was to identify and describe distinct trajectories of response to atomoxetine using hierarchical clustering methods and linear mixed modelling.
Based on the homogeneity of changes in CAARS-Inv:SV total scores, 5 response clusters were identified for patients who completed long-term (24 weeks) treatment with atomoxetine, and 4 clusters were identified for patients who completed short-term (12 weeks) treatment. Four of the 5 long-term clusters (comprising 95% of completer patients) showed positive trajectories: 2 faster responding clusters (L1 and L2), and 2 more gradually responding clusters (L3 and L4). Responses (i.e. ≥ 30% reduction in CAARS-Inv:SV total score, and CGI-S score ≤ 3) were observed at 8 and 24 weeks in 80% and 95% of completers in Cluster L1, versus 5% and 48% in Cluster L4.
While many adults with ADHD responded relatively rapidly to atomoxetine, others responded more gradually without a clear plateau at 24 weeks. Longer-term treatment may be associated with greater numbers of responders.
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