Publication and Disclosure Issues in Antidepressant Pediatric Clinical Trials PDF Download

Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 724

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Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309133386
Category : Medical
Languages : en
Pages : 445

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Book Description
In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

Author: Alison Bass
Publisher: Algonquin Books
ISBN: 1565126432
Category : Medical
Languages : en
Pages : 273

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As the mental health reporter for the Boston Globe, Alison Bass's front-page reporting on conflicts of interest in medical research stunned readers, and her series on sexual misconduct among psychiatrists earned a Pulitzer Prize nomination. Now she turns her investigative skills to a controversial case that exposed the increased suicide rates among adolescents taking antidepressants such as Paxil, Prozac, and Zoloft. Side Effects tells the tale of a gutsy assistant attorney general who, along with an unlikely whistle-blower at an Ivy League university, uncovered evidence of deception behind one of the most successful drug campaigns in history. Paxil was the world's bestselling antidepressant in 2002. Pediatric prescriptions soared, even though there was no proof that the drug performed any better than sugar pills in treating children and adolescents, and the real risks the drugs posed were withheld from the public. The New York State Attorney General's office brought an unprecedented lawsuit against giant manufacturer GlaxoSmithKline, the maker of Paxil, for consumer fraud. The successful suit launched a tidal wave of protest that changed the way drugs are tested, sold, and marketed in this country. With meticulous research, Alison Bass shows us the underbelly of the pharmaceutical industry. She lays bare the unhealthy ties between the medical establishment, big pharma, and the FDA—relationships that place vulnerable children and adults at risk every day.

Author: Scott N. Compton
Publisher: Academic Press
ISBN: 0128130059
Category : Psychology
Languages : en
Pages : 571

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Pediatric Anxiety Disorders provides a critical, updated and comprehensive overview of anxiety disorders in children and adolescents based on the current state of empirical research. The book provides specific clinical recommendations which integrate new knowledge from neuroscience and innovative delivery formats for interventions. This is the first reference to examine anxiety diagnoses in accordance with the latest edition of the DSM-5, including childhood onset disorders, such as Separation Anxiety Disorder, Selective Mutism, Specific Phobia, Social Anxiety Disorder, Panic Disorder, Agoraphobia and Generalized Anxiety Disorder. The book assists clinicians in critically appraising the certainty of the evidence-base and the strength of clinical recommendations. - Uses the latest edition of the Diagnostic and Statistical Manual of Mental Disorders, the DSM-5 - Includes the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach in assessing guideline development - Focuses on advances in etiology, assessment and treatment - Presents new advances in our understanding of the brain behind fear and anxiety - Uses a stepped care approach to treatment

Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 734

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Author: United States. Congress. House. Committee on Energy and Commerce
Publisher:
ISBN:
Category : Energy policy
Languages : en
Pages : 308

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Author:
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 600

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Author: Alexander Glassman
Publisher: John Wiley & Sons
ISBN: 1119957621
Category : Medical
Languages : en
Pages : 110

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Book Description
Recently, there has been a growing awareness of the multiple interrelationships between depression and various physical diseases. Patients with psychiatric problems, particularly depression, may be more susceptible to cardiovascular disorders. Depression and Heart Disease synthesizes current evidence, including some previously unpublished data, in a concise, easy-to-read format. The authors succinctly describe the epidemiology, pathogenesis (including cytokines and genetics), and risk factors of the comorbidity between depression and heart disease. The book also reviews the best pharmacological and psychotherapeutic approaches for people with this comorbidity.

Author: Graziano Pinna
Publisher:
ISBN: 9781634820769
Category :
Languages : en
Pages : 412

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Fluoxetine, best known by the trade name Prozac®, unlike other psychotropic drugs whose effects were serendipitously stumbled upon, was the first developed for a precise mechanism of action, that is, the ability to selectively inhibit serotonin reuptake, based upon the theory that increasing the availability of serotonin would treat major depression. Once approved by the FDA in 1987, fluoxetine quickly became the most prescribed psychotropic drug worldwide and its success in improving mood disorders has triggered the development of a large number of congener molecules, commonly known as SSRIs after their purported mechanism of action. However, a quarter of a century after its development, the idea that fluoxetine asserts its positive behavioral effect through inhibition of serotonergic reuptake is not firmly established. This book reviews several preclinical and clinical reports suggesting that the pharmacological effects of fluoxetine may be mediated by means other than the regulation of serotonin, including the regulation of gene expression, modifying epigenetic mechanisms as well as modifying microRNAs. One of the most prominent mechanisms for the therapeutic relevance of fluoxetine relates to influencing neuroplasticity by enhancing neurotropic factors, including BDNF signaling and altering adult neurogenesis. The ability of fluoxetine to rapidly increase neurosteroid levels accounts for the fast anxiolytic effects of this drug. Fluoxetine action at sigma-1 receptor or modulating glutamatergic neurotransmission as well as the combination of fluoxetine with other psychotropic drugs is discussed in relation to its therapeutic effects. While fluoxetine was primarily prescribed as an antidepressant, this drug currently represents a treatment of choice for a broad spectrum of psychiatric disorders, including post-traumatic stress disorder and a range of anxiety disorders. This drug even possesses analgesic actions and is a valuable therapy for stroke. This book also highlights emerging evidence on the gender-specific effects of fluoxetine, its potential adverse features, including its addiction liability in combination with psychostimulants, and the impact of perinatal fluoxetine exposure.

Author: Laura Mufson
Publisher: Guilford Press
ISBN: 9781593850425
Category : Psychology
Languages : en
Pages : 344

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Grounded in extensive research and clinical experience, this manual provides a complete guide to interpersonal psychotherapy for depressed adolescents (IPT-A). IPT-A is an evidence-based brief intervention designed to meet the specific developmental needs of teenagers. Clinicians learn how to educate adolescents and their families about depression, work with associated relationship difficulties, and help clients manage their symptoms while developing more effective communication and interpersonal problem-solving skills. The book includes illustrative clinical vignettes, an extended case example, and information on the model's conceptual and empirical underpinnings. Helpful session checklists and sample assessment tools are featured in the appendices.