The non-interventional study VIVALDI was carried out to evaluate the treatment with agomelatine, an innovative antidepressant, in routine practice.665 psychiatrists treated 3 317 patients over 12 ...weeks with agomelatine and documented antidepressant effects via svMADRS, CGI scale and CircScreen questionnaire. Subgroups with severe depression (svMADRS ≥30) and elderly patients (≥65 years) were also analyzed.In the total population, svMADRS total score decreased from 30.6 at baseline to 12.8 at final visit, in severely depressed patients from 36.7 to 14.7, in elderly patients from 29.0 to 12.2. In total 65.8% of patients could be classified as responders (≥50% decrease in svMADRS total score) and 54.8% as remitters (svMADRS ≤12). Daytime sleepiness was ameliorated in 78.2% of patients. Adverse drug reactions were reported for 10.0%, 8.9% and 10.1% of patients in total population, severely ill and elderly patients, respectively.In this study, the antidepressant effects, improvement of circadian rhythm disorders and good tolerability of agomelatine were observed in unselected depressed patients, including multimorbid elderly and severely depressed patients under routine practice.
Abstract
Therapeutic drug monitoring (TDM) is the quantification and interpretation of drug concentrations in blood to optimize pharmacotherapy. It considers the interindividual variability of ...pharmacokinetics and thus enables personalized pharmacotherapy. In psychiatry and neurology, patient populations that may particularly benefit from TDM are children and adolescents, pregnant women, elderly patients, individuals with intellectual disabilities, patients with substance abuse disorders, forensic psychiatric patients or patients with known or suspected pharmacokinetic abnormalities. Non-response at therapeutic doses, uncertain drug adherence, suboptimal tolerability, or pharmacokinetic drug-drug interactions are typical indications for TDM. However, the potential benefits of TDM to optimize pharmacotherapy can only be obtained if the method is adequately integrated in the clinical treatment process. To supply treating physicians and laboratories with valid information on TDM, the TDM task force of the Arbeitsgemeinschaft für Neuropsychopharmakologie und Pharmakopsychiatrie (AGNP) issued their first guidelines for TDM in psychiatry in 2004. After an update in 2011, it was time for the next update. Following the new guidelines holds the potential to improve neuropsychopharmacotherapy, accelerate the recovery of many patients, and reduce health care costs.
All German societies of medicine have been ordered by the Federal Association of Physicians (Bundesärztekammer) to propose new revised regulations for the education of residents. The German ...Association for Psychiatry, Psychotherapy and Psychosomatics (DGPPN) is offering a broad extension of education in psychotherapy while education in pharmacotherapy is still rather small and limited. The working group Biological Psychiatry of the German Association of Psychiatric Hospitals (Bundesdirektorenkonferenz, BDK) suggests a detailed proposal of a psychopharmacology curriculum based on a Delphi method consent of medical directors involved in the education of the majority of German psychiatric residents. Issues include general pharmacology, neurobiological principles, clinical pharmacology of different classes of psychotropics (antidepressants, antipsychotics, mood stabilizers, anxiolytics, hypnotics, stimulants etc.), special aspects (e.g. pregnancy, geriatric patients) as well as ethical, legal and economic aspects. About 160 hours of theoretical education are proposed, clinical teaching should be interactive, with vignettes and supervision covering about 300 hours.
Psychiatric disorders can be caused or strongly associated by endocrine and metabolic diseases. Especially depressive and anxiety disorders can occur with hypoglycemia, diabetes mellitus, ...hypothyroidism, hyperthyroidism, hypoparathyroidism. Endocrinological alterations and disturbances in the HPA-/HPT-axis are consistent findings in depressive disorders. Type 2 diabetes is also associated with cognitive dysfunction. Database on pharmacotherapy is sparse and partly inconclusive due to low-quality trials and the heterogenity of examined populations. In diabetes pts treatment with antidepressants showed clinically significant effects on depression outcomes, RCTs regarding maintenance therapy with SSRIs preventive effects for depression recurrence. On the other hand endocrine and metabolic side effects of psychotropics must be kept in mind. Second generation antipsychotics like risperidone, olanzapine or quetiapine are associated with hyperprolactinemia, hyperglycemia, impaired glucose metabolism, clinically with increased risk of metabolic syndromes, diabetes, amenorrhea, galactorrhea and sexual dysfunction. SSRIs have been associated with the syndrome of inappropriate antidiuretic hormone secretion. Lithium long-term treatment can lead to (subclinical) hypothyroidism. From a clinical point of view in some cases treatment with psychostimulants (i.e. methylphenidate) can help patients with medical diseases. Recommendations for the use of different psychotropics in endocrine and metabolic diseases are presented.
Monoamine oxidase inhibitors (MAO-I) have been useful in the treatment of both psychiatric and neurological disorders over centuries. Here we focus on the development of this drug treatment. Focus is ...given on the use of irreversible MAO-Is as well as on reversible ones. Benefit and side effects are reported for Parkinsons disease, Alzheimers dementia, depression syndrome and panic disorders. The preclinical and clinical effects of selegiline with regard to neuroprotection are highlightened and the conclusion is drawn that there is good evidence for a clinical neuroprotective capacity based on the assumption that the 50 percent recovery of MAO-B is obtained already after a 10 days withdrawal of selegiline. There is also a focus on selegilines metabolism to amphetamine and metamphetamine. In order to avoid any such effects of metabolic compounds on the cardiovascular system Zydis Selegiline, a melt-tablet avoid of major metabolism to amphetamine and metamphetamine is described in detail. Developments in MAO-I research are discussed in detail as there are moclobemide, lacabemide, rasagiline. Interactions of MAO-I with tricyclics and serotonin selective reuptake inhibitors (SSRIs) are described as there is mentioning of interactions of MAO-Is with other compounds in general. Tables and figures report on clinical studies and on pharmacological properties of MAO-Is.
Therapeutic Drug Monitoring (TDM) is a valid tool to optimise pharmacotherapy. It enables the clinician to adjust the dosage of drugs according to the characteristics of the individual patient. In ...psychiatry, TDM is an established procedure for lithium, some antidepressants and antipsychotics. In spite of its obvious advantages, however, the use of TDM in everyday clinical practice is far from optimal. The interdisciplinary TDM group of the Arbeitsgemeinschaft fur Neuropsychopharmakologie und Pharmakopsychiatrie (AGNP) has therefore worked out consensus guidelines to assist psychiatrists and laboratories involved in psychotropic drug analysis to optimise the use of TDM of psychotropic drugs. Five research-based levels of recommendation were defined with regard to routine monitoring of plasma concentrations for dose titration of 65 psychoactive drugs: (1) strongly recommended, (2) recommended, (3) useful, (4) probably useful and (5) not recommended. A second approach defined indications to use TDM, e. g. control of compliance, lack of clinical response or adverse effects at recommended doses, drug interactions, pharmacovigilance programs, presence of a genetic particularity concerning the drug metabolism, children, adolescents and elderly patients. Indications for TDM are relevant for all drugs either with or without validated therapeutic ranges. When studies on therapeutic ranges are lacking, target ranges should be plasma concentrations that are normally observed at therapeutic doses of the drug. Therapeutic ranges of plasma concentrations that are considered to be optimal for treatment are proposed for those drugs, for which the evaluation of the literature demonstrated strong evidence. Moreover, situations are defined when pharmacogenetic (phenotyping or genotyping) tests are informative in addition to TDM. Finally, practical instructions are given how to use TDM. They consider preparation of TDM, analytical procedures, reporting and interpretation of results and the use of information for patient treatment. Using the consensus guideline will help to ensure optimal clinical benefit of TDM in psychiatry.
Objective Agomelatine is a melatonergic agonist and 5-HT2C antagonist with demonstrated antidepressant efficacy in clinical trials. The aim of the non-interventional study VIVALDI was to examine the ...antidepressant efficacy and tolerability of agomelatine in depressed patients in daily practice. Methods 3317 outpatients aged > 18 years with first or recurrent depressive episodes were observed by 665 German psychiatrists over 12 weeks. Patients were treated with agomelatine 25–50 mg once daily at bedtime. Antidepressant efficacy was evaluated by the svMADRS (short version MADRS) and CGI scales, effects on sleep and daily activity by a patient questionnaire (CircScreen). Results At inclusion, patients showed moderate to severe depression (svMADRS: 0 = 30.6), demonstrating an steady and marked clinical improvement during the 12 weeks of agomelatine treatment (svMADRS: 0 = 12.8). The responder rate (≥50% reduction of svMADRS) rose steadily from 12.3% (2 weeks) to 42.7% (6 weeks) and 65.8% (12 weeks). After 3 months, 54.8% of patients were in remission (svMADRS ≤12). On the CGI scale, 22.8% of patients responded (CGI-I ≤2) after 2 weeks and 72.4% after 12 weeks of treatment with agomelatine. Decrease in repeated and early morning awakenings, and increase daily activities were observed after 12 weeks in 81.5%, 82% and 56.6% of patients, respectively. The tolerability of agomelatine was good. Conclusion The antidepressant efficacy of agomelatine on depressive symptoms and daytime activities, as well as its tolerability observed in controlled trials were confirmed by the results of the non-interventional study VIVALDI.
Introduction In most European countries postgraduate training for specialization in psychiatry and psychotherapy is acquired over the course of 4–6-year programs. In the European Union, qualification ...in one country is recognized within other countries of the Union. Objectives and aims To analyze the present situation of psychopharmacology-pharmacopsychiatry postgraduate teaching in Europe and to present the needs and preliminary instruments for improving the situation by harmonization of the programs. Methods Analysis of the data available from national psychiatric societies and from the literature; development of a consensus among experts in this field. Results Despite efforts to standardize post-graduate training, the curricula in different European countries vary greatly. This variability limits comparability between countries and international exchange while carrying consequences in the breadth and quality of education that trainees receive. Literature and curricula mainly published in USA as well as a recently published curriculum and learning catalogue in Germany 1 offer useful tools for the development of a curriculum at a European level. Conclusions There is clearly a need for standardization of psychopharmacology-pharmacopsychiatry teaching at the European level. This can be achieved by the introduction of a curriculum and learning catalogue developed by European experts and based on tools already available.
Comorbid depressive and anxiety disorders are associated with chronic physical illnesses. Treatment with antidepressants and mood stabilizers require knowledge about toxicity, potential side effects, ...and drug interactions. According to controlled studies in comorbid cardiovascular diseases, diabetes mellitus, and cerebrovascular disorders (post-stroke depression), serotonin-selective reuptake inhibitors (SSRIs), e.g., sertraline and citalopram, are preferred. Pramipexole, reboxetine, mirtazapine, or nortriptyline showed efficacy in treatment of Parkinson depression. Chronic pain syndromes can be improved with low-dose tricyclic antidepressants. Both establishment of compliance and follow-up examinations are essential. Combined treatment with psychotherapeutic interventions, including coping strategies, should be used whenever possible.
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