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77-409: The introduction of this act was influenced by the death of more than 100 patients due to elixir sulfanilamide , a sulfanilamide medication where the toxic solvent diethylene glycol was used to dissolve the drug and make a liquid form. It replaced the earlier Pure Food and Drug Act of 1906. The FDC Act has ten chapters: The FD&C Act is perhaps best known to consumers because of its use in

154-509: A Nobel Prize but did not receive one. By 1940, the procedure was introduced to both England and the US. In Germany and Austria, it was promoted by Friedrich Meggendorfer . Through the 1940s and 1950s, the use of ECT became widespread. At the time the ECT device was patented and commercialized abroad, the two Italian inventors had competitive tensions that damaged their relationship. In the 1960s, despite

231-550: A clinical trial it is significantly more expensive than a 510(k). The Food and Drug Administration Modernization Act of 1997 created section 513(f)(2) of the FD&;C Act, which obligated the FDA to establish a risk-based regulatory system for medical devices. As a result, the FDA established a de novo pathway for devices that would automatically be classified as Class III because there was no already-existing device that could be used

308-444: A medical device . This is known as premarket notification, PMN, or 510(k). It allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Any device that reaches market via a 510(k) notification must be "substantially equivalent" to

385-475: A stroke ; who have increased intracranial pressure (for instance, due to a solid brain tumor ), or who have severe pulmonary conditions, or who are generally at high risk for receiving anesthesia. In adolescents, ECT is highly efficient for several psychiatric disorders, with few and relatively benign adverse effects. A meta-analysis from 2017 found that the death rate of ECT was around 2.1 per 100,000 procedures. A review from 2011 reported an estimate of

462-462: A Canadian guideline and some experts arguing for using ECT as a first line treatment, ECT is generally used only when one or other treatments have failed, or in emergencies, such as imminent suicide. ECT has also been used in selected cases of depression occurring in the setting of multiple sclerosis , Parkinson's disease , Huntington's chorea , developmental delay , brain arteriovenous malformations , and hydrocephalus . A meta-analysis on

539-573: A climate of condemnation, the original Cerletti-Bini ECT apparatus prototype was contended by scientific museums between Italy and the US. The ECT apparatus prototype is now owned and displayed by the Sapienza Museum of the History of Medicine in Rome. In the early 1940s, in an attempt to reduce the memory disturbance and confusion associated with treatment, two modifications were introduced:

616-516: A component or otherwise affecting the characteristic of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use); if such substance is not GRAS or sanctioned prior to 1958 or otherwise excluded from the definition of food additives." The full definition can be found in Section 201(s) of

693-421: A device on the market prior to May 28, 1976 (a "predicate device"). If a device being submitted is significantly different, relative to a pre-1976 device, in terms of design, material, chemical composition, energy source, manufacturing process, or intended use, the device nominally must go through a premarket approval, or PMA. A device that reaches market via the 510(k) process is not considered to be "approved" by

770-534: A greater risk of memory impairment. Retrograde amnesia is most marked for events occurring in the weeks or months before treatment. Anterograde memory loss usually resolves 2–4 weeks after treatment, whereas retrograde amnesia (which develops gradually after repeated treatments in the initial course) usually takes weeks to months to resolve, and amnesia rarely persist for more than 1 year. Retrograde amnesia after ECT usually affects autobiographical memory, rather than semantic memory . One published review summarizing

847-514: A half times seizure threshold for bilateral ECT and up to 12 times for unilateral ECT. Below these levels treatment may not be effective in spite of a seizure, while doses massively above threshold level, especially with bilateral ECT, expose patients to the risk of more severe cognitive impairment without additional therapeutic gains. Seizure threshold is determined by trial and error (" dose titration "). Some psychiatrists use dose titration, some still use "fixed dose" (that is, all patients are given

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924-541: A large effect size (high efficacy relative to the mean in terms of the standard deviation ) for ECT versus placebo, and versus antidepressant drugs. Compared with repetitive transcranial magnetic stimulation (rTMS) for people with treatment-resistant major depressive disorder, ECT relieves depression as shown by reducing the score on the Hamilton Rating Scale for Depression by about 15 points, while rTMS reduced it by 9 points. Other estimates regarding

1001-425: A meta-analysis found in terms of efficacy, "a significant superiority of ECT in all comparisons: ECT versus simulated ECT, ECT versus placebo , ECT versus antidepressants in general, ECT versus tricyclics and ECT versus monoamine oxidase inhibitors ." In 2003, The UK ECT Review Group published a systematic review and meta-analysis comparing ECT to placebo and antidepressant drugs. This meta-analysis demonstrated

1078-484: A minimum fine under provisions of the 1906 Pure Food and Drugs Act, which prohibited labeling the preparation an " elixir " if it contained no ethanol . Electroconvulsive therapy Electroconvulsive therapy ( ECT ) or electroshock therapy ( EST ) is a psychiatric treatment during which a generalized seizure (without muscular convulsions ) is electrically induced to manage refractory mental disorders . Typically, 70 to 120 volts are applied externally to

1155-541: A predicate for a 510k submission, but for which general controls or general and special controls could provide a reasonable assurance of safety and effectiveness. The Wheeler-Lea Act , passed in 1938, granted the Federal Trade Commission the authority to oversee advertising of all products regulated by FDA, other than prescription drugs. Descriptions of these can be found at the FDA's web site. Amendments: Other laws: Some US states have adopted

1232-465: A psychiatric or medical condition (e.g., when illness is characterized by suicidality , psychosis , stupor , marked psychomotor retardation , depressive delusions or hallucinations , or life-threatening physical exhaustion associated with mania)." It has also been used to treat autism in adults with an intellectual disability, yet findings from a systematic review found this an unestablished intervention. For major depressive disorder , despite

1309-426: A reasonable certainty that no harm will result from the intended use of an additive. If the FDA finds an additive to be safe the agency issues a regulation specifying the conditions under which the additive may be safely used. A shortened definition of "food additive" is defined by the FDA as "any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming

1386-490: A research project that verified that the DEG solvent was responsible for the fatal adverse effects . At least 100 deaths were blamed on the medication. The owner of the company, when pressed to admit some measure of culpability, infamously answered, "We have been supplying a legitimate professional demand and not once could have foreseen the unlooked-for results. I do not feel that there was any responsibility on our part." Watkins,

1463-409: A shock to the head produced convulsions in dogs. The idea to use electroshock on humans came to Cerletti when he saw how pigs were given an electric shock before being butchered to put them in an anesthetized state. Cerletti and Bini practiced until they felt they had the right parameters needed to have a successful human trial. Once they started trials on patients, they found that after 10–20 treatments

1540-402: A study purporting to show an absence of cognitive impairment in eight subjects after more than 100 lifetime ECT treatments. Kellner stated "Rather than cause brain damage, there is evidence that ECT may reverse some of the damaging effects of serious psychiatric illness." Two meta-analyses find that ECT is associated with brain matter growth. If steps are taken to decrease potential risks, ECT

1617-402: Is evidence and rationale to support giving low doses of benzodiazepines or otherwise low doses of general anesthetics , which induce sedation but not anesthesia , to patients to reduce adverse effects of ECT. While there are no absolute contraindications for ECT, there is increased risk for patients who have unstable or severe cardiovascular conditions or aneurysms ; who have recently had

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1694-404: Is generally accepted to be relatively safe during all trimesters of pregnancy, particularly when compared to pharmacological treatments. Suggested preparation for ECT during pregnancy includes a pelvic examination , discontinuation of nonessential anticholinergic medication, uterine tocodynamometry, intravenous hydration, and administration of a nonparticulate antacid . During ECT, elevation of

1771-407: Is generally acknowledged". For people with autism spectrum disorders who have catatonia, there is little published evidence about the efficacy of ECT. ECT is used to treat people who have severe or prolonged mania ; NICE recommends it only in life-threatening situations or when other treatments have failed and as a second-line treatment for bipolar mania . ECT is widely used worldwide in

1848-465: Is my plea that you will take steps to prevent such sales of drugs that will take little lives and leave such suffering behind and such a bleak outlook on the future as I have tonight." Congress responded to public outrage by passing the 1938 Food, Drug, and Cosmetic Act, which required companies to perform animal safety tests on their proposed new drugs and submit the data to the FDA before being allowed to market their products. The Massengill Company paid

1925-420: Is no defined schedule for maintenance ECT, however it is usually started weekly with intervals extended permissibly with the goal of maintaining remission. When ECT is followed by treatment with antidepressants , about 50% of people relapsed by 12 months following successful initial treatment with ECT, with about 37% relapsing within the first 6 months. About twice as many relapsed with no antidepressants. Most of

2002-449: Is regulated by the FDA as a food. The Agency has published identity standards for types of water ( mineral water , spring water), and regulations covering water processing and bottling, water quality and product labeling. This Act defines cosmetics as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body ... for cleansing, beautifying, promoting attractiveness, or altering

2079-716: Is thought to be the father of convulsive therapy. In 1937, the first international meeting on schizophrenia and convulsive therapy was held in Switzerland by the Swiss psychiatrist Max Müller. The proceedings were published in the American Journal of Psychiatry and, within three years, cardiazol convulsive therapy was being used worldwide. The ECT procedure was first conducted in 1938 by Italian neuro-psychiatrist Ugo Cerletti and rapidly replaced less safe and effective forms of biological treatments in use at

2156-520: The National Institute of Mental Health and National Institutes of Health convened a consensus development conference on ECT and concluded that, while ECT was the most controversial treatment in psychiatry and had significant side-effects, it had been shown to be effective for a narrow range of severe psychiatric disorders. Because of the backlash noted previously, national institutions reviewed past practices and set new standards. In 1978,

2233-458: The 510(k) pathway, the maker of the medical device must submit an application to the FDA and must receive approval prior to marketing the device. The PMA application contains information about how the medical device was designed and how it is manufactured, as well as preclinical and clinical studies of the device, demonstrating that it is safe and effective for its intended use. Because the PMA requires

2310-564: The American Psychiatric Association released its first task force report in which new standards for consent were introduced and the use of unilateral electrode placement was recommended. The 1985 NIMH Consensus Conference confirmed the therapeutic role of ECT in certain circumstances. The American Psychiatric Association released its second task force report in 1990 where specific details on the delivery, education, and training of ECT were documented. Finally, in 2001

2387-410: The American Psychiatric Association released its latest task force report. This report emphasizes the importance of informed consent , and the expanded role that the procedure has in modern medicine. By 2017, ECT was routinely covered by insurance companies for providing the "biggest bang for the buck" for otherwise intractable cases of severe mental illness , was receiving favorable media coverage, and

Federal Food, Drug, and Cosmetic Act of 1938 - Misplaced Pages Continue

2464-551: The FD&C Act as an equivalent state law and will by default adopt any changes to the Federal law as changes to the state law as well. Elixir sulfanilamide Elixir sulfanilamide was an improperly prepared sulfonamide antibiotic that caused mass poisoning in the United States in 1937. It is believed to have killed more than 100 people. The public outcry caused by this incident and other similar disasters led to

2541-424: The FD&C Act was amended to include regulation for medical devices . The amendment required that all medical devices be classified into one of three classes: For devices that were marketed prior to the amendment (preamendment devices) and were classified as Class III, the amendment obligated the FDA to review the device to either reclassify it as a Class II device subject to premarket notification, or to require

2618-843: The FD&C Act, which provides for any additional exclusions. Homeopathic preparations are regulated and protected under Sections 201(g) and 201(j), provided that such medications are formulated from substances listed in the Homeopathic Pharmacopoeia of the United States, which the Act recognizes as an official drug compendium. However, under separate authority of FTC Act , the Federal Trade Commission declared in November 2016 that homeopathic products cannot include claims of effectiveness without "competent and reliable scientific evidence". If no such evidence exists, they must state this fact clearly on their labeling. Bottled water

2695-402: The FDA using the less stringent, and cheaper, 510(k) process. In a few cases the devices had been deemed so low-risk that they did not need FDA regulation. Of the 113 devices recalled, 35 were for cardiovascular issues. This may lead to a reevaluation of FDA procedures and better oversight. Premarket approval (PMA) is the most stringent type of device marketing application required by FDA. Unlike

2772-679: The FDA. Nevertheless, it can be marketed and sold in the United States. They are generally referred to as "cleared" or "510(k) cleared" devices. A 2011 study by Diana Zuckerman and Paul Brown of the National Research Center for Women and Families , and Steven Nissen of the Cleveland Clinic, published in the Archives of Internal Medicine, showed that most medical devices recalled in the last five years for "serious health problems or death" had been previously cleared by

2849-490: The appearance." Under the Act, the FDA does not approve cosmetic products, but the Act prohibits the marketing of adulterated or misbranded cosmetics. However, the FDA does not have the authority to order recalls of cosmetics. If a company is selling a product that is adulterated or misbranded, the FDA can ask the company to recall their product or sue them. The FDA can and does inspect cosmetics manufacturing facilities to ensure that cosmetics are not adulterated. On May 28, 1976,

2926-529: The brain, the general physical risks of ECT are similar to those of brief general anesthesia . Immediately following treatment, the most common adverse effects are confusion and transient memory loss. Among treatments for severely depressed pregnant women, ECT is one of the least harmful to the fetus . ECT is often used as an intervention for major depressive disorder , mania , autism , and catatonia . The usual course of ECT involves multiple administrations, typically given two or three times per week until

3003-590: The brain, the general physical risks of ECT are similar to those of brief general anesthesia ; the US Surgeon General 's report says that there are "no absolute health contraindications " to its use. Immediately following treatment, the most common adverse effects are confusion and memory loss. Some patients experience muscle soreness after ECT. Other common adverse effects after ECT include headache, jaw soreness, nausea, vomiting and fatigue. These side effects are transient and respond to treatment. There

3080-504: The chemist, committed suicide while awaiting trial. A woman wrote to U.S. President Roosevelt and described the death of her daughter: "The first time I ever had occasion to call in a doctor for [Joan] and she was given Elixir of Sulfanilamide. All that is left to us is the caring for her little grave. Even the memory of her is mixed with sorrow for we can see her little body tossing to and fro and hear that little voice screaming with pain and it seems as though it would drive me insane. ... It

3157-436: The concern surrounding its use. However, the methods used to measure memory loss are non-specific, and their application to people with depressive disorders, who have cognitive deficits related to the depression, including problems with memory, may further limit their utility. The acute effects of ECT can include amnesia , both retrograde (for events occurring before the treatment) and anterograde (for events occurring after

Federal Food, Drug, and Cosmetic Act of 1938 - Misplaced Pages Continue

3234-536: The device manufacturer to undergo the premarket authorization process and prove the safety and efficacy of the device in order to continue marketing it. Notable examples of such preamendment devices are those used for electroconvulsive therapy , which the FDA started reviewing in 2011. Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires those device manufacturers who must register to notify FDA, at least 90 days in advance, of their intent to market

3311-403: The dose and duration of the stimulation is determined on a per-patient basis. In unilateral ECT, both electrodes are placed on the same side of the patient's head. Unilateral ECT may be used first to minimize side effects such as memory loss. In bilateral ECT, the two electrodes are placed on opposite sides of the head. Usually bitemporal placement is used, whereby the electrodes are placed on

3388-463: The effectiveness of ECT in unipolar and bipolar depression indicated that although patients with unipolar depression and bipolar depression responded to other medical treatments very differently, both groups responded equally well to ECT. Overall remission rate for patients given a round of ECT treatment was 50.9% for those with unipolar depression and 53.2% for those with bipolar depression. Most severely depressed patients respond to ECT. In 2004,

3465-456: The effectiveness of his constant current, brief pulse device ECT. This device eventually largely replaced earlier devices because of the reduction in cognitive side effects, although as of 2012 some ECT clinics still were using sine-wave devices. The 1970s saw the publication of the first American Psychiatric Association (APA) task force report on electroconvulsive therapy (to be followed by further reports in 1990 and 2001). The report endorsed

3542-424: The electric current is passed from one side of the brain to the other, or unilateral, in which the current is solely passed across one hemisphere of the brain. High-dose unilateral ECT has some cognitive advantages compared to moderate-dose bilateral ECT while showing no difference in antidepressant efficacy. As early as the 16th century, agents to induce seizures were used to treat psychiatric conditions. In 1785,

3619-413: The elixir sulfanilamide poisonings. In 1937, S. E. Massengill Company , a pharmaceutical manufacturer, created an oral preparation of sulfanilamide using diethylene glycol (DEG) as the solvent or excipient , and called the preparation "Elixir Sulfanilamide". DEG is poisonous to humans and other mammals, but Harold Watkins, the company's chief pharmacist and chemist, was not aware of this. (Although

3696-404: The evidence for continuation therapy is with tricyclic antidepressants ; evidence for relapse prevention with newer antidepressants is lacking. Adjunct maintenance ECT paired with cognitive behavioral therapy has also been shown to reduce relapse rates. Maintenance ECT may safely continue indefinitely, with no set maximum treatment interval established. Lithium has also been found to reduce

3773-446: The first case of a fatality from the related ethylene glycol occurred in 1930 and studies had been published in medical journals stating DEG could cause kidney damage or failure, its toxicity was not widely known prior to the incident.) Watkins simply mixed raspberry flavoring into the powdered drug and then dissolved the mixture in DEG. Animal testing was not required by law, and Massengill performed none; there were no regulations at

3850-419: The long bones. In the 1940s, psychiatrists began to experiment with curare , the muscle-paralysing South American poison, in order to modify the convulsions. The introduction of suxamethonium (succinylcholine), a safer synthetic alternative to curare, in 1951 led to the more widespread use of "modified" ECT. A short-acting anesthetic was usually given in addition to the muscle relaxant in order to spare patients

3927-544: The mid-19th century "Father of Electrotherapy", said its use was integral to a neurological practice. In the second half of the 19th century, such efforts were frequent enough in British asylums as to make it notable. Convulsive therapy was introduced in 1934 by Hungarian neuropsychiatrist Ladislas J. Meduna who, believing mistakenly that schizophrenia and epilepsy were antagonistic disorders, induced seizures first with camphor and then metrazol (cardiazol). Meduna

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4004-455: The mortality rate associated with ECT as less than 1 death per 73,440 treatments. Cognitive impairment sometimes occurs after ECT. The American Psychiatric Association (APA) report in 2001 acknowledges: "In some patients the recovery from retrograde amnesia will be incomplete, and evidence has shown that ECT can result in persistent or permanent memory loss". It is the purported effects of ECT on long-term memory that give rise to much of

4081-760: The naming of food coloring additives, such as "FD&C Yellow No. 6". The Act made the certification of some food color additives mandatory. The FDA lists nine FD&C (Food, Drugs & Cosmetics) certified color additives for use in foods in the United States, and numerous D&C (Drugs & Cosmetics) colorings allowed only in drugs for external application or cosmetics. Color additives derived from natural sources, such as vegetables, minerals or animals, and artificial counterparts of natural derivatives, are exempt from certification. Both artificial and naturally derived color additives are subject to rigorous standards of safety before their approval for use in foods. The FFDCA requires producers of food additives to demonstrate to

4158-536: The negative portrayal of ECT in the popular media." The New York Times described the public's negative perception of ECT as being caused mainly by one movie: "For Big Nurse in One Flew Over the Cuckoo's Nest , it was a tool of terror, and, in the public mind, shock therapy has retained the tarnished image given it by Ken Kesey 's novel: dangerous, inhumane and overused". In 1976, Dr. Blatchley demonstrated

4235-604: The passing of the 1938 Federal Food, Drug, and Cosmetic Act , which significantly increased the Food and Drug Administration 's powers to regulate drugs. Aside from the Pure Food and Drug Act of 1906 and the Harrison Act of 1914 banning the sale of some narcotic drugs, there was no federal regulatory control in the United States of America for drugs until Congress enacted the 1938 Food, Drug, and Cosmetic Act in response to

4312-406: The patient no longer has symptoms. ECT is administered under anesthesia with a muscle relaxant . ECT can differ in its application in three ways: electrode placement, treatment frequency, and the electrical waveform of the stimulus. These treatment parameters can pose significant differences in both adverse side effects and symptom remission in the treated patient. Placement can be bilateral, where

4389-530: The patient's capacity for informed consent. ECT can cause a lack of blood flow and oxygen to the heart, heart arrhythmia , and "persistent asystole ". A 2019 systematic review and meta-analysis of 82 studies found that the rate of major adverse cardiac events with ECT was 1 in 39 patients or about 1 in 200 to 500 procedures. The risk of death with ECT however is low. If death does occur, cardiovascular complications are considered as causal in about 30% of individuals. The placement of electrodes, as well as

4466-460: The patient's head, resulting in approximately 800 milliamperes of direct current passing between the electrodes, for a duration of 100 milliseconds to 6 seconds, either from temple to temple (bilateral ECT) or from front to back of one side of the head (unilateral ECT). However, only about 1% of the electrical current crosses the bony skull into the brain because skull impedance is about 100 times higher than skin impedance. Aside from effects on

4543-427: The pregnant woman's right hip, external fetal cardiac monitoring, intubation , and avoidance of excessive hyperventilation are recommended. In many instances of active mood disorder during pregnancy, the risks of untreated symptoms may outweigh the risks of ECT. Potential complications of ECT during pregnancy can be minimized by modifications in technique. The use of ECT during pregnancy requires thorough evaluation of

4620-495: The procedure is safe and does not cause brain damage. Dr. Charles Kellner, a prominent ECT researcher and former chief editor of the Journal of ECT , stated in a 2007 interview that, "There are a number of well-designed studies that show ECT does not cause brain damage and numerous reports of patients who have received a large number of treatments over their lifetime and have suffered no significant problems due to ECT." Kellner cites

4697-429: The response rate in treatment resistant depression vary between 60–80%, with a remission rate of 50–60%. In addition to reducing symptoms of depression and inducing relapse, ECT has also been shown to reduce the risk of suicide, improve functional outcomes and quality of life as well as reduce the risk of re-hospitalization. Efficacy does not depend on depression subtype. With regards to treatment resistant schizophrenia,

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4774-408: The response rate is 40–70%. There is little agreement on the most appropriate follow-up to ECT for people with major depressive disorder. The initial course of ECT is then transitioned to maintenance ECT, pharmacotherapy or both. When ECT is stopped abruptly, without a bridge to maintenance ECT or medications (usually antidepressants and Lithium ), it is associated with a relapse rate of 84%. There

4851-434: The results of questionnaires about subjective memory loss found that between 29% and 55% of respondents believed they experienced long-lasting or permanent memory changes. In 2000, American psychiatrist Sarah Lisanby and colleagues found that bilateral ECT left patients with more persistently impaired memory of public events as compared to right unilateral ECT. However, bilateral ECT may be more efficacious than unilateral in

4928-402: The results were significant. Patients had much improved. A positive side effect to the treatment was retrograde amnesia . It was because of this side effect that patients could not remember the treatments and had no ill feelings toward it. ECT soon replaced metrazol therapy all over the world because it was cheaper, less frightening and more convenient. Cerletti and Bini were nominated for

5005-399: The risk of relapse, especially in younger patients. ECT is generally a second-line treatment for people with catatonia who do not respond to other treatments, but is a first-line treatment for severe or life-threatening catatonia. There is a plethora of evidence for its efficacy, notwithstanding a lack of randomised controlled trials, such that "the excellent efficacy of ECT in catatonia

5082-571: The temples. Uncommonly bifrontal placement is used; this involves positioning the electrodes on the patient's forehead, roughly above each eye. Unilateral ECT is thought to cause fewer cognitive effects than bilateral treatment, but is less effective unless administered at higher doses. Most patients in the US and almost all in the UK receive bilateral ECT. The electrodes deliver an electrical stimulus. The stimulus levels recommended for ECT are in excess of an individual's seizure threshold: about one and

5159-451: The terrifying feeling of suffocation that can be experienced with muscle relaxants. The steady growth of antidepressant use along with negative depictions of ECT in the mass media led to a marked decline in the use of ECT during the 1950s to the 1970s. The Surgeon General stated there were problems with electroshock therapy in the initial years before anesthesia was routinely given, and that "these now-antiquated practices contributed to

5236-699: The therapeutic use of seizure induction was documented in the London Medical and Surgical Journal . As to its earliest antecedents one doctor claims 1744 as the dawn of electricity's therapeutic use, as documented in the first issue of Electricity and Medicine . Treatment and cure of hysterical blindness was documented eleven years later. Benjamin Franklin wrote that an electrostatic machine cured "a woman of hysterical fits." By 1801, James Lind as well as Giovanni Aldini had used galvanism to treat patients with various mental disorders. G.B.C. Duchenne,

5313-546: The time requiring premarket safety testing of drugs. The company started selling and distributing the medication in September 1937. By October 11, the American Medical Association received a report of several deaths caused by the medication. The Food and Drug Administration was notified, and an extensive search was conducted to recover the distributed medicine. Frances Oldham Kelsey assisted on

5390-542: The time. Cerletti, who had been using electric shocks to produce seizures in animal experiments, and his assistant Lucio Bini at Sapienza University of Rome developed the idea of using electricity as a substitute for metrazol in convulsive therapy and, in 1938, experimented for the first time on a person affected by delusions . It was believed early on that inducing convulsions aided in helping those with severe schizophrenia but later found to be most useful with affective disorders such as depression . Cerletti had noted

5467-578: The treatment of schizophrenia , but in North America and Western Europe it is invariably used only in treatment resistant schizophrenia when symptoms show little response to antipsychotics ; there is comprehensive research evidence for such practice. It is useful in the case of severe exacerbations of catatonic schizophrenia , whether excited or stuporous. There are also case reports of ECT improving persistent psychotic symptoms associated with stimulant-induced psychosis . Aside from effects in

5544-727: The treatment of mood disorders. ECT has not been found to increase the risk of dementia nor cause structural brain damage. Considerable controversy exists over the effects of ECT on brain tissue, although a number of mental health associations—including the APA—have concluded that there is no evidence that ECT causes structural brain damage. A 1999 report by the US Surgeon General states: "The fears that ECT causes gross structural brain pathology have not been supported by decades of methodologically sound research in both humans and animals." Many expert proponents of ECT maintain that

5621-581: The treatment). Memory loss and confusion are more pronounced with bilateral electrode placement rather than unilateral, and with outdated sine-wave rather than brief-pulse currents. The use of either constant or pulsing electrical impulses also varied the memory loss results in patients. Patients who received pulsing electrical impulses, as opposed to a steady flow, seemed to incur less memory loss. The vast majority of modern treatment uses brief pulse currents. A greater number of treatments and higher electrical charges (stimulus charges) have also been associated with

5698-409: The use of ECT in the treatment of depression. The decade also saw criticism of ECT. Specifically, critics pointed to shortcomings such as noted side effects, the procedure being used as a form of abuse, and uneven application of ECT. The use of ECT declined until the 1980s, "when use began to increase amid growing awareness of its benefits and cost-effectiveness for treating severe depression". In 1985,

5775-411: The use of unilateral electrode placement and the replacement of sinusoidal current with brief pulse. It took many years for brief-pulse equipment to be widely adopted. In the 1940s and early 1950s, ECT was usually given in an "unmodified" form, without muscle relaxants, and the seizure resulted in a full-scale convulsion. A rare but serious complication of unmodified ECT was fracture or dislocation of

5852-415: Was being provided in regional medical centers. Though ECT use declined with the advent of modern antidepressants, there has been a resurgence of ECT with new modern technologies and techniques. Modern shock voltage is given for a shorter duration of 0.5 milliseconds where conventional brief pulse is 1.5 milliseconds. In a review from 2022 of neuroimaging studies based on a global data collaboration ECT

5929-413: Was suggested to work via a temporary disruption of neural circuits followed by augmented neuroplasticity and rewiring. ECT is used, where possible, with informed consent in treatment-resistant major depressive disorder , bipolar depression , treatment-resistant catatonia , prolonged or severe mania , and in conditions where "there is a need for rapid, definitive response because of the severity of

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