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Study 329
Study 329 was a clinical trial which was conducted in North America from 1994 to 1998 to study the efficacy of paroxetine, an SSRI anti-depressant, in treating 12- to 18-year-olds diagnosed with major depressive disorder. Led by Martin Keller, then professor of psychiatry at Brown University, and funded by the British pharmaceutical company SmithKline Beecham—known since 2000 as GlaxoSmithKline (GSK)—the study compared paroxetine with imipramine, a tricyclic antidepressant, and placebo (an inert pill). SmithKline Beecham had released paroxetine in 1991, marketing it as Paxil in North America and Seroxat in the UK. The drug attracted sales of $11.7 billion in the United States alone from 1997 to 2006, including $2.12 billion in 2002, the year before it lost its patent. Published in July 2001 in the ''Journal of the American Academy of Child and Adolescent Psychiatry'' (''JAACAP''), which listed Keller and 21 other researchers as co-authors, study 329 became controver ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Paroxetine
Paroxetine, sold under the brand names Paxil and Seroxat among others, is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is used to treat major depressive disorder, obsessive-compulsive disorder, panic disorder, social anxiety disorder, posttraumatic stress disorder, generalized anxiety disorder and premenstrual dysphoric disorder. It has also been used in the treatment of premature ejaculation and hot flashes due to menopause. It is taken by mouth. Common side effects include drowsiness, dry mouth, loss of appetite, sweating, trouble sleeping, and sexual dysfunction. Serious side effects may include suicidal thoughts in those under the age of 25, serotonin syndrome, and mania. While the rate of side effects appears similar compared to other SSRIs and SNRIs, antidepressant discontinuation syndromes may occur more often. Use in pregnancy is not recommended, while use during breastfeeding is relatively safe. It is believed to work by blocking th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Journal Of The American Academy Of Child And Adolescent Psychiatry
The ''Journal of the American Academy of Child and Adolescent Psychiatry'' is a peer-reviewed medical journal covering pediatric psychiatry. It is published by Elsevier and is the official journal of the American Academy of Child and Adolescent Psychiatry. The editor-in-chief is Douglas Novins. According to the ''Journal Citation Reports'', its 2014 impact factor is 7.26, ranking it first among 119 journals in the category "Pediatrics". It is abstracted and indexed in MEDLINE/PubMed, and Science Citation Index. Call for retraction The group Healthy Skepticism has accused the journal of having published an article, in 2001, that misrepresented the results of an industry-sponsored clinical trial, study 329. The study examined the use of paroxetine Paroxetine, sold under the brand names Paxil and Seroxat among others, is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is used to treat major depressive disorder, obsessive-compulsive disorder, ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Keller2001
Keller may refer to: People *Keller (surname) * Helen Keller *Keller Williams, jam-band musician *Keller E. Rockey Places India * Keller, Shopian United States *Keller, Georgia *Keller, Indiana *Keller, Texas * Keller, Virginia *Keller, Washington Other * Keller (automobile) * Keller beer, a style of beer * Keller Graduate School of Management * Keller Group, a British-based ground engineering company See also * Helen Keller International * Keller Sisters and Lynch *Gottfried-Keller-Preis The Gottfried-Keller-Preis, prix Gottfried-Keller, or premio Gottfried Keller is one of the oldest literary awards of Switzerland. The prize was created by Martin Bodmer and is named after the Swiss author Gottfried Keller. It is awarded every tw ... * Cellarius, a surname * Justice Keller (other) {{Disambiguation, geo, given name ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Selective Serotonin Reuptake Inhibitor
Selective serotonin reuptake inhibitors (SSRIs) are a class of drugs that are typically used as antidepressants in the treatment of major depressive disorder, anxiety disorders, and other psychological conditions. SSRIs increase the extracellular level of the neurotransmitter serotonin by limiting its reabsorption (reuptake) into the presynaptic cell. They have varying degrees of selectivity for the other monoamine transporters, with pure SSRIs having strong affinity for the serotonin transporter and only weak affinity for the norepinephrine and dopamine transporters. SSRIs are the most widely prescribed antidepressants in many countries. The efficacy of SSRIs in mild or moderate cases of depression has been disputed and may or may not be outweighed by side effects, especially in adolescent populations. Medical uses The main indication for SSRIs is major depressive disorder; however, they are frequently prescribed for anxiety disorders, such as social anxiety disorder, gen ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Fiona Godlee
Fiona Godlee (born August 4, 1961) was editor in chief of '' The British Medical Journal'' from March 2005 until 31 December 2021; she was the first female editor appointed in the journal's history. She was also editorial director of the other journals in ''BMJ's'' portfolio. Career Fiona Godlee attended Bedales and Marlborough College boarding schools. She qualified as a doctor in 1985 at the University of Cambridge School of Clinical Medicine, having studied at Trinity College, Cambridge. She trained as a general physician in London, and is a Fellow of the Royal College of Physicians. Since 1990 she has written on a broad range of issues for BMJ, including the impact of environmental degradation on health, the future of the World Health Organization, the ethics of academic publication, and the problems of editorial peer review. In 1994, she spent a year at Harvard University as a Harkness Fellow evaluating efforts to bridge the gap between medical research and practice. On r ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States Department Of Justice
The United States Department of Justice (DOJ), also known as the Justice Department, is a federal executive department of the United States government tasked with the enforcement of federal law and administration of justice in the United States. It is equivalent to the justice or interior ministries of other countries. The department is headed by the U.S. attorney general, who reports directly to the president of the United States and is a member of the president's Cabinet. The current attorney general is Merrick Garland, who was sworn in on March 11, 2021. The modern incarnation of the Justice Department was formed in 1870 during the Ulysses S. Grant presidency. The department comprises federal law enforcement agencies, including the Federal Bureau of Investigation, the U.S. Marshals Service, the Bureau of Alcohol, Tobacco, Firearms and Explosives, the Drug Enforcement Administration, and the Federal Bureau of Prisons. It also has eight major divisions of lawyers who re ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Eliot Spitzer
Eliot Laurence Spitzer (born June 10, 1959) is an American politician and attorney. A member of the Democratic Party, he was the 54th governor of New York from 2007 until his resignation in 2008. Spitzer was born in New York City, attended Princeton University, and earned his law degree from Harvard. He began his career as an attorney in private practice with New York law firms before becoming a prosecutor with the office of the New York County (Manhattan) District Attorney. From 1999 to 2006, he was the Attorney General of New York, earning a reputation as the "Sheriff of Wall Street" for his efforts to curb corruption in the financial services industry. Spitzer was elected Governor of New York in 2006 by the largest margin of any candidate, but his tenure lasted less than two years after it was uncovered he patronized a prostitution ring. He resigned immediately following the scandal, and his lieutenant governor, David Paterson, served the rest of his term. Since leavin ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not d ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Off-label Use
Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs. Off-label use is very common and generally legal unless it violates ethical guidelines or safety regulations. The ability to prescribe drugs for uses beyond the officially approved indications is commonly used to good effect by healthcare providers. For example, methotrexate is commonly used off-label because its immunomodulatory effects relieve various disorders. However, off-label use can entail health risks and differences in legal liability. Marketing of pharmaceuticals for off-label use is usually prohibited. Indications and labeling laws An '' indication'' is when a drug is medically appropriate for a given condition; an ''approved indication'' is when a government drug re ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Suicidal Ideation
Suicidal ideation, or suicidal thoughts, means having thoughts, ideas, or ruminations about the possibility of ending one's own life.World Health Organization, ''ICD-11 for Mortality and Morbidity Statistics'', ver. 09/2020MB26.A Suicidal ideation/ref> It is not a diagnosis but is a symptom of some mental disorders and can also occur in response to adverse events without the presence of a mental disorder.Barry, Lisa C. Passive Suicidal Ideation in Older Adults: Implications for Suicide Prevention, ''American Journal of Geriatric Psychiatry'' 27, no. 12 (December 2019): 1411 ("... growing evidence points toward a subgroup of individuals who endorse passive SI uicidal ideationin later life outside the context of clinical depression.") On suicide risk scales, the range of suicidal ideation varies from fleeting thoughts to detailed planning. Passive suicidal ideation is thinking about not wanting to live or imagining being dead. Active suicidal ideation involves preparation to comm ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medicines And Healthcare Products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe. The MHRA was formed in 2003 with the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). In April 2013, it merged with the National Institute for Biological Standards and Control (NIBSC) and was rebranded, with the MHRA identity being used solely for the regulatory centre within the group. The agency employs more than 1,200 people in London, York and South Mimms, Hertfordshire. Structure The MHRA is divided into three main centres: * MHRA Regulatory – the regulator for the pharmaceutical and medical devices industries * Clinical Practice Research Datalink – licences anonymised health care data to pharmaceutical companies, academics and other regulators for research * National Institute for Bio ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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