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 controv ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   [Amazon] |
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Paroxetine
Paroxetine ( ), sold under the brand name Paxil among others, is an Antidepressant, antidepressant medication of the selective serotonin reuptake inhibitor (SSRI) class used to treat major depressive disorder, obsessive-compulsive disorder, obsessive–compulsive disorder (OCD), panic disorder, social anxiety disorder, post-traumatic stress disorder (PTSD), 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 oral administration, orally (by mouth). Common side effects include drowsiness, dry mouth, loss of appetite, sweating, insomnia, 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 syndrome may occur more often. Use in pregnancy is not r ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   [Amazon] |
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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 by teenagers. The trial was sponsored by, and ghostwritten on behalf of, SmithKline Beecham (now GlaxoSmithKline GSK plc (an acronym from its former name GlaxoSmithKline plc) is a British Multinational corporation, multinational P ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   [Amazon] |
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Keller2001
Keller may refer to: People * Keller (surname) * Keller (given name) Places United States * Keller, Georgia, an unincorporated community * Keller, Indiana, an unincorporated community * Keller, Texas, a city * Keller, Virginia, a town * Keller, Washington, an unincorporated community and census-designated place Elsewhere * Keller, Shopian, India, a village * Keller, Zonguldak, Turkey, a village * Keller Inlet, Palmer Land, Antarctica * Keller Lake, Northwest Territories, Canada * Keller Island, an islet near Ushant, a French island in the English Channel Other uses * Keller (automobile) * Keller beer, a style of beer * Keller Golf Course, a public golf course in Maplewood, Minnesota, United States * Keller Graduate School of Management, a former school of DeVry University form 1970 to 1990 * Keller High School, Keller, Texas * Keller Group, a British-based ground engineering company * Kevin Keller (character), a fictional character in the Archie Comics universe * Rachel Kell ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   [Amazon] |
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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 primarily work by blocking serotonin reabsorption (reuptake) via the serotonin transporter, leading to gradual changes in brain signaling and receptor regulation, with some also interacting with sigma-1 receptors, particularly fluvoxamine, which may contribute to cognitive effects. Marketed SSRIs include six main antidepressants— citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, and sertraline—while dapoxetine is indicted for premature ejaculation. Fluoxetine has been approved for veterinary use in treatment of canine separation anxiety. SSRIs are the most widely prescribed antidepressants in many countries. Their effectiveness, especially for mild to moderate depression, remains debated due to mixed research findings and concerns abo ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   [Amazon] |
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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 retu ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   [Amazon] |
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United States Department Of Justice
The United States Department of Justice (DOJ), also known as the Justice Department, is a United States federal executive departments, federal executive department of the U.S. government that oversees the domestic enforcement of Law of the United States, federal laws and the administration of justice. It is equivalent to the Ministry of justice, 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 United States Cabinet, Cabinet. Pam Bondi has served as U.S. attorney general since February 4, 2025. The Justice Department contains most of the United States' Federal law enforcement in the United States, 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. Th ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   [Amazon] |
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Eliot Spitzer
Eliot Laurence Spitzer (born June 10, 1959) is an American politician and attorney who served as the 54th governor of New York from 2007 until his resignation in 2008 after a prostitution scandal. A member of the Democratic Party, he was also the 63rd attorney general of New York from 1999 to 2006. Born in the Bronx, Spitzer attended Princeton University and earned his Juris Doctor degree from Harvard Law School. 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. Spitzer defeated Republican incumbent Dennis Vacco in 1998 to become state attorney general, earning a reputation as the "Sheriff of Wall Street" for his efforts to curb corruption in the financial services industry. He 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 prostitutio ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   [Amazon] |
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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). However, 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 ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   [Amazon] |
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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 regula ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   [Amazon] |
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Suicidal Ideation
Suicidal ideation, or suicidal thoughts, is the thought process of having ideas or ruminations about the possibility of dying by suicide.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, use of certain psychoactive drugs, and can also occur in response to adverse life circumstances 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. ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   [Amazon] |
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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 ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   [Amazon] |