Guidelines for the recording and evaluation of pharmaco-EEG data in man: the International Pharmaco-EEG Society (IPEG)

The International Pharmaco-EEG Society (IPEG) presents updated guidelines summarising the requirements for the recording and computerised evaluation of pharmaco-EEG data in man. Since the publication of the first pharmaco-EEG guidelines in 1982, technical and data processing methods have advanced steadily, thus enhancing data quality and expanding the palette of tools available to investigate the action of drugs on the central nervous system (CNS), determine the pharmacokinetic and pharmacodynamic properties of novel therapeutics and evaluate the CNS penetration or toxicity of compounds. However, a review of the literature reveals inconsistent operating procedures from one study to another. While this fact does not invalidate results per se, the lack of standardisation constitutes a regrettable shortcoming, especially in the context of drug development programmes. Moreover, this shortcoming hampers reliable comparisons between outcomes of studies from different laboratories and hence also prevents pooling of data which is a requirement for sufficiently powering the validation of novel analytical algorithms and EEG-based biomarkers. The present updated guidelines reflect the consensus of a global panel of EEG experts and are intended to assist investigators using pharmaco-EEG in clinical research, by providing clear and concise recommendations and thereby enabling standardisation of methodology and facilitating comparability of data across laboratories

A Retrospective Review of Supratherapeutic Modafinil Exposures

Modafinil is a non-amphetamine wakefulness-promoting agent used for the treatment of various sleep disorders characterized by excessive daytime sleepiness. There is little information in the medical literature with respect to supratherapeutic doses of this medication. We performed a retrospective review of the California Poison Control System database for all cases of single-substance ingestion of modafinil with follow-up to a known outcome for the time period 1998–2008. Data collected included age, gender, dose ingested, clinical effects, and medical outcome. There were a total of 87 patients, 53 (61%) of which were female. Patient ages ranged from 1.25 to 72 years with a mean of 30 years; 17 (20%) patients were aged 6 years or less. Thirty-three (38%) were intentional overdoses. Most commonly reported effects were tachycardia (n = 23), agitation (n = 14), anxiety (n = 11), headache (n = 8), hypertension (n = 6), dystonia/tremor (n = 6), and dizziness (n = 5). Forty-nine patients (56%) were managed at home, and 38 (44%) were managed in a healthcare setting. Therapies administered included activated charcoal (n = 8), benzodiazepines (n = 7), antihistamines (n = 2), intravenous fluids (n = 2), haloperidol (n = 2), and beta-blockers (n = 1). Effects were classified as none (n = 22), minor (n = 54), and moderate (n = 11). No major effects and no deaths occurred. Effects of modafinil overdose appear to be mild in most cases, with tachycardia and CNS symptoms predominating. Clinically significant effects requiring treatment occurred in a small number of patients

Objective and Subjective Components of the First-Night Effect in Young Nightmare Sufferers and Healthy Participants

The first-night effect—marked differences between the first- and the second-night sleep spent in a laboratory—is a widely known phenomenon that accounts for the common practice of excluding the first-night sleep from any polysomnographic analysis. The extent to which the first-night effect is present in a participant, as well as its duration (1 or more nights), might have diagnostic value and should account for different protocols used for distinct patient groups. This study investigated the first-night effect on nightmare sufferers (NM; N D 12) and healthy controls .N D 15/ using both objective (2-night-long polysomnography) and subjective (Groningen Sleep Quality Scale for the 2 nights spent in the laboratory and 1 regular night spent at home) methods. Differences were found in both the objective (sleep efficiency, wakefulness after sleep onset, sleep latency, Stage-1 duration, Stage-2 duration, slow-wave sleep duration, and REM duration) and subjective (self-rating) variables between the 2 nights and the 2 groups, with a more pronounced first-night effect in the case of the NM group. Furthermore, subjective sleep quality was strongly related to polysomnographic variables and did not differ among 1 regular night spent at home and the second night spent in the laboratory. The importance of these results is discussed from a diagnostic point of view

Orexin Receptor Antagonism, a New Sleep-Enabling Paradigm: A Proof-of-Concept Clinical Trial

Peer reviewe

Trazodone for the treatment of fibromyalgia: an open-label, 12-week study

Background: Despite its frequent use as a hypnotic, trazodone has not been systematically assessed in fibromyalgia patients. In the present study have we evaluated the potential effectiveness and tolerability of trazodone in the treatment of fibromyalgia. Methods: A flexible dose of trazodone (50-300 mg/day), was administered to 66 fibromyalgia patients for 12 weeks. The primary outcome measure was the Pittsburgh Sleep Quality Index (PSQI). Secondary outcome measures included the Fibromyalgia Impact Questionnaire (FIQ), the Beck Depression Inventory (BDI), the Hospital Anxiety and Depression Scale (HADS), the Brief Pain Inventory (BPI), the Short-Form Health Survey (SF-36), and the Patients' Global Improvement Scale (PGI). Trazodone's emergent adverse reactions were recorded. Data were analyzed with repeated measures one-way ANOVA and paired Student's t test. Results: Trazodone markedly improved sleep quality, with large effect sizes in total PSQI score as well on sleep quality, sleep duration and sleep efficiency. Significant improvement, although with moderate effect sizes, were also observed in total FIQ scores, anxiety and depression scores (both HADS and BDI), and pain interference with daily activities. Unexpectedly, the most frequent and severe side effect associated with trazodone in our sample was tachycardia, which was reported by 14 (21.2%) patients. Conclusions: In doses higher than those usually prescribed as hypnotic, the utility of trazodone in fibromyalgia management surpasses its hypnotic activity. However, the emergence of tachycardia should be closely monitored. Trial registration: This trial has been registered with ClinicalTrials.gov number NCT-00791739

EEG Biofeedback as a Treatment for Substance Use Disorders: Review, Rating of Efficacy, and Recommendations for Further Research

Electroencephalographic (EEG) biofeedback has been employed in substance use disorder (SUD) over the last three decades. The SUD is a complex series of disorders with frequent comorbidities and EEG abnormalities of several types. EEG biofeedback has been employed in conjunction with other therapies and may be useful in enhancing certain outcomes of therapy. Based on published clinical studies and employing efficacy criteria adapted by the Association for Applied Psychophysiology and Biofeedback and the International Society for Neurofeedback and Research, alpha theta training—either alone for alcoholism or in combination with beta training for stimulant and mixed substance abuse and combined with residential treatment programs, is probably efficacious. Considerations of further research design taking these factors into account are discussed and descriptions of contemporary research are given

Desempenho ocupacional das famílias cuidadoras de pessoas com transtornos mentais atendidas em dispositivo de atenção psicossocial

With the process of psychiatric institutionalization, treatment of people with mental disorders, characterized by long before psychiatric hospitalizations, chronicity and social exclusion, went on to defend the humanized care, the integration of the individual in the family and society. The family of the person with a mental disorder, for a considerable time was excluded from the assistance provided to his family. He is currently an important partner of care, since most people who were treated in closed institutions, today live daily with their caregivers, at home. However, families often are not prepared to act as caretakers of close family members with mental disorders, and thus experience a context of overloads in everyday life. It is not uncommon the fact they have not with satisfactory support to deal with the complex situation of caring for a relative who needs care at length in daily life. This research aims to describe the areas of occupational performance (work, rest and sleep, leisure and social participation), the caregivers families before and after the mental illness of his family and the repercussions of this fact in daily life and living conditions of family caregivers; Identify among the areas of occupational performance (work, rest and sleep, leisure and social participation), those considered most important for family caregivers, and the strategies used by them for the development of these areas, with a view to changes in their daily lives and their living conditions. This is a qualitative, critical and reflective study. Approved by the Research Ethics Committee (CEP) of the University Hospital Lauro Wanderley the Federal University of Paraíba, in the period from July 2014 to February 2015. The instrument for data collection was semi-structured interviews. Data collection took place in October and November 2014, after receiving the assent of the CEP. The material was subjected to the analysis of data according to Minayo (2008), following three methodological steps: pre-analysis, material exploration, processing of data and interpretation. The research findings revealed that with regard to the areas of occupational performance (work, rest and sleep, leisure and social participation) of family before becoming caregivers, four of them worked before the mental illness of their relatives and family, by the will of spouse, only performed housework. With regard to rest and sleep, the five family caregivers, two reported not enjoy a good rest and sleep before getting sick of your family, a fact surely occasioned negative impact on the dynamics of your everyday life . The other three caregivers had a good rest and sleep. It was identified that the leisure of the caregivers in this study, before the mental illness of the family, was designed and related to diverse aspects. The five family caregivers interviewed reported an active social participation, whether in church, community groups, in the family. With regard to the areas of occupational performance after mental illness the family, all family caregivers have had to stop work activities outside the home to care for relatives with mental disorders. The rest and sleep of them had to suffer. The leisure and social participation of family caregivers were determined by dynamic behavior of their relatives with mental disorders. With regard to the areas of occupational performance considered the most important by family caregivers, they elected two: rest and sleep and social participation. With the completion of this study, we can see the relevance of the intervention of health workers, because through dialogue and more systematic follow-up to these families, you can help minimize the impact of a life in organized care and overloads generated by these care and so contribute to improving the quality of life of families and caregivers also of users with mental disorders.Com o processo de desinstitucionalização psiquiátrica, o tratamento das pessoas com transtornos mentais antes caracterizados por longas internações psiquiátricas, cronificação e exclusão social, passou a defender o cuidado humanizado, a reinserção do indivíduo na família e na sociedade. A família da pessoa com transtorno mental, durante tempo considerável foi excluída da assistência prestada ao seu familiar. Atualmente é uma importante parceira do cuidado, pois muitas pessoas que eram tratadas em instituições fechadas, hoje convivem diariamente com seus cuidadores, no domicílio. Porém, as famílias, muitas vezes, não estão preparadas para atuar como cuidadoras desses familiares com transtornos mentais, e assim vivenciam um contexto de sobrecargas no cotidiano. Não é raro o fato de não contarem com suporte satisfatório para lidar com a complexa situação de cuidar de um familiar, o qual necessita de cuidados durante um tempo considerável no cotidiano. Esta pesquisa tem como objetivo descrever as áreas de desempenho ocupacional (trabalho; descanso e sono; lazer e participação social), das famílias cuidadoras, antes e após o adoecimento mental dos seus familiares e as repercussões desse fato no cotidiano e nas condições de vida dos familiares cuidadores; Identificar dentre as áreas de desempenho ocupacional (trabalho; descanso e sono; lazer e participação social), as que são consideradas mais importantes para os familiares cuidadores, e as estratégias utilizadas por eles para o desenvolvimento dessas áreas, com vistas a mudanças no seu cotidiano e nas suas condições de vida. Trata-se de estudo qualitativo, crítico e reflexivo. Aprovado pelo Comitê de Ética e Pesquisa (CEP) do Hospital Universitário Lauro Wanderley da Universidade Federal da Paraíba, desenvolvido no período de julho de 2014 a fevereiro de 2015. O instrumento para coleta de dados foi a entrevista semiestruturada. A coleta de dados aconteceu nos meses de outubro e novembro de 2014, após recebimento do parecer favorável do CEP. O material foi submetido a análise de dados segundo Minayo (2008), seguindo três passos metodológicos: pré-análise, exploração do material, tratamento dos dados obtidos e interpretação. Os achados da pesquisa revelaram que no tocante às áreas de desempenho ocupacional (trabalho, descanso e sono, lazer e participação social) dos familiares antes de se tornarem cuidadores, quatro delas trabalhavam antes do adoecimento mental de seus familiares e uma familiar, por vontade do esposo, só realizava trabalhos domésticos. No que diz respeito ao descanso e sono, das cinco cuidadoras familiares, duas relataram não desfrutarem de um bom descanso e sono, antes do processo de adoecimento do seu familiar, fato este, com certeza, que ocasionava repercussões negativas na dinâmica de seu dia a dia. As outras três cuidadoras apresentavam bom descanso e sono. Identificou-se que o lazer das cuidadoras desse estudo, antes do adoecimento mental do familiar, era concebido e relacionado a aspectos diversificados. As cinco cuidadoras familiares entrevistadas relataram uma participação social atuante, seja na igreja, nos grupos comunitários e na família. No que diz respeito às áreas de desempenho ocupacional após o adoecimento mental do familiar, todas as cuidadoras familiares tiveram de interromper as atividades de trabalho fora de casa para cuidar de familiares com transtornos mentais. O descanso e sono delas apresentavam-se prejudicados. O lazer e a participação social das cuidadoras familiares eram determinados pela dinâmica de comportamento dos seus familiares com transtornos mentais. No concernente às áreas de desempenho ocupacional consideradas as mais importantes pelas cuidadoras familiares, estas elegeram duas: descanso e sono e participação social. Com a realização desse estudo, percebe-se a relevância da intervenção dos trabalhadores da saúde, pois mediante o diálogo e acompanhamento mais sistemático a essas famílias, pode-se contribuir para minimizar o impacto de uma vida organizada em cuidados e sobrecargas geradas por esses cuidados e assim colaborar para a melhoria da qualidade de vida das famílias cuidadoras e também dos usuários com transtornos mentais