A Single-dose, Randomized, Open-label, Crossover Bioequivalence Study of Generic Desvenlafaxine 50 mg Extended-release Tablets and Reference Product in Healthy Thai Volunteers under Fasting and Fed Conditions

开始日期2024-07-01

申办/合作机构

Unison Laboratories Co. Ltd.

NCT04446039

/ CompletedN/A

Comparison of Antidepressants in the Real-World: Retrospective Cohort Study Using Big Data

The primary purpose of this study is to investigate medication utilization pattern and risk of adverse outcomes among commonly used antidepressants by using nationwide claims database, in order to assess overall clinical benefit of antidepressant therapy in real-world practice.

开始日期2022-07-04

申办/合作机构

Pfizer Inc.

CTRI/2021/11/038260

/ Not yet recruitingN/AIIT

Evaluating effect of Escitalopram and Desvenlafaxine on anxiety and BDNF level in depression with comorbid anxiety â?? An open label, randomized, parallel group, clinical study - NIL

开始日期2021-12-01

申办/合作机构-

100 项与富马酸酯去甲文拉法辛相关的临床结果

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100 项与富马酸酯去甲文拉法辛相关的转化医学

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100 项与富马酸酯去甲文拉法辛相关的专利（医药）

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项与富马酸酯去甲文拉法辛相关的文献（医药）

2024-12-01·JOURNAL OF HAZARDOUS MATERIALS

Towards sustainable water reuse: A critical review and meta-analysis of emerging chemical contaminants with risk-based evaluation, health hazard prediction and prioritization for assessment of effluent water quality

Review

作者: Stålsby Lundborg, Cecilia ; Khan, Uzair Akbar ; Wiberg, Karin ; Löffler, Paul ; Spilsbury, Francis ; Lai, Foon Yin

Reuse of treated wastewater is necessary to address water shortages in a changing climate. Sustainability of wastewater reuse requires reducing the environmental impacts of contaminants of emerging concern (CECs), but it is being questioned as CECs are not regulated in the assessment of effluent water quality for reuse both nationally in Sweden and at the broader European Union level. There is also a lack of details in this topic on which CECs to be addressed and methodologies to be used for assessing their environmental impacts. A better understanding of the ecological risks and health hazards of CECs associated with wastewater reuse will assist in the development of effective regulations on water reuse, (inter)nationally, as well as related treatment/monitoring guidelines. This review provides a list of specific chemical CECs that hinder sustainable wastewater reuse, and also demonstrates a holistic quantitative methodology for assessing, scoring and prioritizing their associated ecological risks and health hazards posed to the environment and humans. To achieve this, we compile information and concentrations of a wide range of CECs (∼15 000 data entries) identified in Swedish effluent wastewater from domestic (blackwater, greywater, mixture of both) and municipal settings, and further perform a meta-analysis of their potentials for 14 risk and hazard features, consisting of ecological risk, environmental hazard, and human health hazard. The features are then scored against defined criteria including guideline values, followed by score ranking for prioritization. This finally produces a unique list of chemical CECs from high to low priority based on risk- and hazard-evaluations. Out of the priority chemicals, 30, mainly pharmaceuticals, had risk quotient ≥ 1, indicating ecological risk, 16 had environmental hazard being persistent and mobile, and around 60 resulted in positive predictions for at least four human health hazards (particularly skin sensitization, developmental toxicity, hepatoxicity, and carcinogenicity). The 10 highest-priority chemicals (final score 2.3-3.0 out of 4.0) were venlafaxine, bicalutamide, desvenlafaxine, diclofenac, amoxicillin, clarithromycin, diethyltoluamide, genistein, azithromycin, and fexofenadine. Potential crop exposure to selected chemicals following one year of wastewater reuse for agricultural irrigation was also estimated, resulting in a range of 0.04 ng/kg (fluoxetine) to 1160 ng/kg (carbamazepine). Overall, our work will help focus efforts and costs on the critical chemicals in future (waste)water-related studies, such as, to evaluate removal efficiency of advanced treatment technologies and to study upstream source tracing (polluter-pays principle), and also in supporting policymakers to better regulate CECs for sustainable wastewater reuse in the future.

2024-12-01·JOURNAL OF PHARMACOLOGICAL SCIENCES

Evaluation of inhibitory actions of antidepressants on muscarinic receptors assessed by a binding assay in the mouse cerebral neocortex

Article

作者: Usami, Yuki ; Yoshioka, Kento ; Tanaka, Yoshio ; Okamoto, Risa ; Obara, Keisuke

We investigated the inhibitory effects of 32 antidepressants on [³H]N-methylscopolamine ([³H]NMS)-specific binding in the mouse cerebral neocortex to determine which antidepressants should be recommended for patients with Alzheimer's disease (AD). Of those tested, nine antidepressants (10^-4 M) exhibited less inhibitory effect on [³H]NMS-specific binding (<35%): tianeptine (a tricyclic); trazodone (a serotonin 5-HT_2A blocker); sulpiride (a dopamine D₂ blocker); fluvoxamine (a selective serotonin reuptake inhibitor (RI)); milnacipran, levomilnacipran, venlafaxine, and desvenlafaxine (serotonin and noradrenaline RIs); and bupropion (a noradrenaline and dopamine RI). Therefore, these antidepressants show little anticholinergic effect in the brain and are recommended for use in patients with AD.

2024-09-01·JOURNAL OF AFFECTIVE DISORDERS

The impact of antidepressant treatment on the network structure of neurocognition and core emotional depressive symptoms among depressed individuals with a history of suicide attempt: An 8-week clinical study

Article

作者: Inja, Ayla ; Turecki, Gustavo ; Richard-Devantoy, Stéphane ; Berlim, Marcelo T ; Garel, Nicolas

BACKGROUND:

A more in-depth understanding of the relationship between depressive symptoms, neurocognition and suicidal behavior could provide insights into the prognosis and treatment of major depressive disorder (MDD) and suicide. We conducted a network analysis among depressed patients examining associations between history of suicide attempt (HSA), core emotional major depression disorder, and key neurocognitive domains.

METHOD:

Depressed patients (n = 120) aged 18-65 years were recruited from a larger randomized clinical trial conducted at the Douglas Institute in Montreal, Canada. They were randomly assigned to receive one of two antidepressant treatments (i.e., escitalopram or desvenlafaxine) for 8 weeks. Core emotional MDD and key neurocognitive domains were assessed pre-post treatment.

RESULTS:

At baseline, an association between history of suicide attempt (HSA) and phonemic verbal fluency (PVF) suggested that HSA patients reported lower levels of the latter. After 8 weeks of antidepressant treatment, HSA became conditionally independent from PVF. Similar results were found for both the HAM-D and the QIDS-SR core emotional MDD/neurocognitive networks.

CONCLUSION:

Network analysis revealed a pre-treatment relationship between a HSA and decreased phonemic VF among depressed patients, which was no longer present after 8 weeks of antidepressant treatment.

项与富马酸酯去甲文拉法辛相关的新闻（医药）

2024-11-25

·PRNewswire

Major Depressive Disorder Market to Register Immense Growth by 2034 Owing to a Robust Pipeline | DelveInsight

With the anticipated introduction of new treatments such as COMP360 (COMPASS Pathways), Zuranolone (SAGE Therapeutics/Biogen), LY03005 (Luye Pharma), REL-1017 (Relmada Therapeutics), Seltorexant (Minerva Neurosciences/Janssen Pharmaceutical), ABV-1504 (BioLite/ABVC BioPharma), and other and increasing disease awareness, it's reasonable to expect a significant transformation in the major depressive disorder market in the coming years. LAS VEGAS, Nov. 25, 2024 /PRNewswire/ -- Major depressive disorder (MDD), commonly referred to as depression, is a serious medical condition that affects a person's mood, behavior, thinking, and physical well-being. It is different from the temporary feelings of sadness that everyone experiences and should not be confused with the deep grief following the loss of a loved one. MDD is typically a recurrent and episodic condition, meaning that someone who has experienced depression and recovered is likely to face additional episodes, often within 2 to 3 years. As per DelveInsight analysis, the total diagnosed prevalent cases of MDD in the 7MM were found to be approximately 44 million cases in 2023, which is expected to increase during the forecast period (2024–2034). Among the severity-specific diagnosed prevalent cases of MDD, the highest prevalence was observed in moderate cases accounting for approximately 17 million cases in the 7MM in 2023 followed by severe cases and mild cases. Major depressive disorder can be addressed through several treatment approaches, including pharmacological interventions, psychotherapy, interventional methods, and lifestyle changes. Initial treatment often involves either medication, psychotherapy, or a combination of both, with combined therapy proving more effective than using either alone. For severe cases of major depression, electroconvulsive therapy is the most effective option. The current range of recommended pharmacological treatments for major depressive disorder primarily includes antidepressants such as monoamines, tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs), and selective reuptake inhibitors, including medications like VRAYLAR, BRINTELLIX (now TRINTELLIX), SPRAVATO, REXULTI, and FETZIMA. In the upcoming major depressive disorder treatment market landscape, there are a plethora of companies investigating agents for use in major depressive disorder which includes Sage Therapeutics, Relmada Therapeutics, Johnson & Johnson Services, Inc., Biogen, COMPASS Pathways, Luye Pharma, and others. Many more pharma companies are conducting clinical trials for therapies for major depressive disorder. To know more about upcoming major depressive disorder therapies showing positive results, visit @ Drugs for Major Depressive Disorder Treatment DelveInsight estimates that the market size for major depressive disorder is expected to grow from USD 7.1 billion in 2023 with a significant CAGR by 2034. The disease awareness and the emergence of new products in the pipeline will add to the market growth in the future. In addition, persistently rising cases of MDD in the forecast period will contribute to the rise in the MDD treatment market. The current pipeline for major depressive disorder includes a range of drugs with diverse mechanisms of action (MoA). COMP360 (COMPASS Pathways) , Zuranolone (SAGE Therapeutics/Biogen) , LY03005 (Luye Pharma) , REL-1017 (Relmada Therapeutics) , seltorexant (Minerva Neurosciences/Janssen Pharmaceutical) , ABV-1504 (BioLite/ABVC BioPharma), and some others are the most promising drugs of this indication. Ongoing research and current trials have the potential to change the MDD market. Keen to know how the MDD market will evolve by 2034? Find out @ Major Depressive Disorder Market Report The potential for effective major depressive disorder treatment in the future is expected to grow with the addition of numerous drugs to the pipeline of new therapeutics. Currently, a variety of candidate drugs for the treatment of major depressive disorder are being tested in various clinical trials, with some showing positive results. Any drug approved with increased safety and efficacy is expected to cause significant changes in the overall major depressive disorder market. Now, let's examine the pipeline therapies under investigation for major depressive disorder COMP360: COMPASS Pathways Phase III COMPASS Pathways is investigating the use of its experimental psilocybin therapy, COMP360, for treating serious mental health conditions like major depressive disorder. COMP360 is a synthesized version of psilocybin, the active compound found in certain "magic mushrooms," and is administered alongside psychological support. Psilocybin has shown promise in therapeutic applications, and COMP360 has been granted Breakthrough Therapy status by the US FDA as well as an Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). Currently, COMPASS Pathways is running a Phase II trial for MDD, with a Phase III trial underway in partnership with Massachusetts General Hospital to further explore its potential in meeting mental health treatment needs. The company is anticipated to release top-line data from two key trials, COMP005 and COMP006, by the fourth quarter of 2024 and mid-2025, respectively, for the treatment of TRD. Zuranolone: SAGE Therapeutics/Biogen Phase III Zuranolone, being developed by SAGE Therapeutics and Biogen, is a next-generation oral, highly potent, and selective positive allosteric modulator, designed for specific targeting of synaptic and extrasynaptic GABAA receptors. The binding sites for neuroactive steroids (NASs) are different from those for GABA, benzodiazepines, and barbiturates. The GABA system, which is the primary inhibitory signaling pathway in the brain and central nervous system (CNS), plays a key role in regulating CNS function. SAGE-217 is currently in phase III clinical development for major depressive disorder and is being evaluated through the LANDSCAPE and NEST clinical trial programs, which include multiple studies involving thousands of participants, with varying dosing regimens, clinical endpoints, and treatment approaches. In February 2023, the US FDA accepted the New Drug Application (NDA) for zuranolone in the treatment of MDD. However, in August 2023, the FDA issued a Complete Response Letter (CRL) regarding the NDA for zuranolone for treating adults with MDD. Sage and Biogen are now assessing the feedback and determining their next steps. LY03005: Luye Pharma LY03005, developed by Luye Pharma, is one of the company's key products in the CNS therapeutic space. It is their exclusive extended-release tablet formulation of ansofaxine hydrochloride, a serotonin-norepinephrine-dopamine triple reuptake inhibitor (SNDRI) designed for treating major depressive disorder. LY03005 aims to offer improved efficacy and fewer side effects compared to conventional antidepressants like SSRIs and SNRIs. Ansofaxine, a prodrug of desvenlafaxine, strongly inhibits dopamine reuptake in addition to serotonin and norepinephrine, demonstrating superior efficacy in clinical trials. In March 2020, the US FDA accepted the NDA submission for LY03005, which is currently in Phase III pivotal clinical trials for MDD treatment. Seltorexant: Minerva Neurosciences/Janssen Pharmaceutical Phase III Seltorexant, developed by Minerva Neurosciences and Janssen Pharmaceutical, is a selective orexin-2 receptor antagonist intended as an adjunctive treatment for major depressive disorder and for managing insomnia. It is the most advanced ORX2-specific molecule in clinical development, acting as an antagonist by binding to its receptor. Seltorexant is being studied for two main uses: insomnia without psychiatric disorders and MDD in patients who do not respond adequately to SSRIs or SNRIs. In May 2024, Johnson & Johnson reported positive topline results from the pivotal Phase III MDD3001 trial, which assessed its efficacy and safety as an add-on therapy to antidepressants in adults and elderly MDD patients. Discover which therapies are expected to grab major MDD market share @ New Treatments for Major Depressive Disorder REL-1017: Relmada Therapeutics Phase III REL-1017, being developed by Relmada Therapeutics, is a novel chemical entity (NCE) and an NMDA receptor (NMDAR) channel blocker that specifically targets overactive channels while preserving normal glutamatergic neurotransmission. The U.S. FDA has granted it Fast Track Designation as an immunotherapy for treating major depressive disorder. In a Phase II trial, REL-1017 exhibited rapid, strong, and lasting antidepressant effects, with statistically significant improvements over placebo in depression measures. The study also indicated a favorable safety, tolerability, and pharmacokinetic profile for the drug. Currently, it is in late-stage development for MDD, being tested in Phase III trials for both adjunctive and monotherapy. In June 2024, Relmada published clinical data from the Reliance I Study. The company is actively enrolling patients in ongoing trials for REL-1017, including Reliance II (Study 302), with top-line results expected in the latter half of 2024, and Relight (Study 304), which is anticipated to provide results about six months after the completion of Study 302. ABV-1504: ABVC BioPharma Phase II ABV-1504, developed by ABVC BioPharma, features PDC-1421 as its active ingredient and is classified as a botanical investigational new drug. Through its subsidiary BioLite, ABVC has completed a Phase II trial of ABV-1504, a botanical Norepinephrine Transporter (NET) inhibitor. This trial, conducted at Stanford University, showed that the PDC-1421 capsule was safe and well-tolerated among six enrolled adult patients. Both low and high doses of PDC-1421 successfully achieved the study's primary endpoints, showing a necessary 40% improvement in ADHD-RS-IV test scores. In April 2023, PDC-1421 was awarded a US patent (US 11,554,154 B2) for the treatment of Major Depressive Disorder (MDD). The drug has also completed a Phase II trial in MDD patients, and the company intends to hold an End of Phase II (EOP II) meeting with the FDA in the near future. Itruvone (PH10): VistaGen Therapeutics Phase II Itruvone (PH10), being developed by VistaGen Therapeutics, is an investigational first-in-class synthetic neurosteroid that is odorless and fast-acting, showing promise for various neuropsychiatric conditions related to depression and suicidal thoughts. VistaGen is focusing on PH10 as a potential quick-acting, non-sedating, and non-addictive treatment for MDD that patients can conveniently self-administer at home. When self-administered, a microgram-level dose of PH10 sprayed into the nose interacts with nasal chemosensory receptors, activating brain neural circuits to produce rapid antidepressant effects without the side effects, systemic exposure, or safety issues associated with FDA-approved treatments for MDD, such as oral antidepressants and esketamine. After successfully completing Phase IIa trials for MDD, VistaGen is now gearing up for the planned Phase IIb clinical development of PH10 for this condition. Moreover, in December 2022, PH10 received fast-track designation from the US FDA. LPCN 1154: Lipocine Phase II LPCN 1154, developed by Lipocine, is an oral formulation of brexanolone designed for rapid relief of postpartum depression. Its active ingredient is a naturally occurring positive allosteric modulator of the GABAa receptor. This medication is intended to provide an "at-home" treatment option, making it more accessible than the current standard care, which involves invasive procedures and hospitalization. In September 2022, the FDA approved Lipocine's proposal to demonstrate the efficacy of LPCN 1154 through a single pivotal pharmacokinetic bridge to the approved IV infusion of brexanolone via a 505(b)(2) NDA submission. In June 2024, Lipocine announced positive topline results from a pivotal pharmacokinetic study, confirming that LPCN 1154 is bioequivalent to IV brexanolone for PPD treatment. Lipocine aims to submit the NDA by the end of the fourth quarter of 2024. Discover more about drugs for major depressive disorder in development @ Major Depressive Disorder Clinical Trials DelveInsight's latest published market report titled as Major Depressive Disorder Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the major depressive disorder country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The major depressive disorder market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of MDD Gender-specific Diagnosed Prevalent Cases of MDD Severity-specific Diagnosed Prevalent Cases of MDD The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM major depressive disorder market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this major depressive disorder market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the major depressive disorder market. Also, stay abreast of the mitigating factors to improve your market position in the major depressive disorder therapeutic space. Related Reports Major Depressive Disorder Pipeline Major Depressive Disorder Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key major depressive disorder companies, including GH Research, Praxis Precision Medicines, AbbVie, Gedeon Richter, Intra-Cellular Therapies, Bristol-Myers Squibb, Relmada Therapeutics, SAGE Therapeutics, Janssen Research & Development, Minerva Neurosciences, Takeda, Neurocrine Biosciences, Pherin Pharmaceuticals, among others. Treatment-Resistant Depression Market Treatment-Resistant Depression Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key TRD companies, including Navitor Pharmaceuticals, Supernus Pharmaceuti, Novartis, Relmada Therapeutics, Beckley Psytech, COMPASS Pathways, Axsome Therapeutics, Celon Pharma, among others. Treatment-Resistant Depression Pipeline Treatment-Resistant Depression Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key treatment-resistant depression companies, including Axsome Therapeutics, COMPASS Pathways, Merck Sharp & Dohme Corp., Navitor Pharmaceuticals, Inc., Taisho Pharmaceutical Co., Ltd., GH Research Limited, Novartis Pharmaceuticals, Reckitt Benckiser LLC, Relmada Therapeutics, Inc., SAGE Therapeutics, Navitor Pharmaceuticals, Sumitomo Dainippon Pharma, Alkermes, AbbVie, Janssen Pharmaceuticals, Celon Pharma, ACADIA Pharmaceuticals, Pherin Pharmaceuticals, ATAI Life Sciences, among others. Postpartum Depression Market Postpartum Depression Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key postpartum depression companies, including Sage Therapeutics, Epharmix, Inc., among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期临床3期临床结果快速通道突破性疗法

2024-06-06

·drugs

Many Patients Have Discontinuation Symptoms After Stopping Antidepressants

THURSDAY, June 6, 2024 -- A considerable proportion of patients have discontinuation symptoms (e.g., dizziness, headache, nausea, insomnia, and irritability) after discontinuing antidepressants, according to a review published online June 5 in The Lancet Psychiatry . Jonathan Henssler, M.D., from the University of Cologne in Germany, and colleagues conducted a systematic review to examine the incidence of antidepressant discontinuation symptoms in patients discontinuing both antidepressants and placebo. Studies investigated cessation or tapering of an established antidepressant drug or placebo among patients with mental, behavioral, or neurodevelopmental disorders. Data were included from 79 studies with 21,002 patients: 16,532 patients discontinued from an antidepressant and 4,470 discontinued from placebo. The researchers found that the incidence of at least one antidepressant discontinuation symptom was 0.31 and 0.17 in 62 study groups after discontinuation of an antidepressant and 22 study groups after discontinuation of placebo, respectively. The summary difference in incidence was 0.08 between antidepressant and placebo groups of included randomized controlled trials. The incidence of severe antidepressant discontinuation symptoms was 0.028 and 0.006 after discontinuation of an antidepressant and placebo, respectively. Higher frequencies of discontinuation symptoms were seen in association with desvenlafaxine, venlafaxine, imipramine, and escitalopram, while higher severity of symptoms was seen in association with imipramine, paroxetine, and either desvenlafaxine or venlafaxine. Substantial heterogeneity was seen for the results. "Evidence that about one in 35 patients suffers from severe antidepressant discontinuation symptoms must be considered preliminary at present, but caution towards severe antidepressant discontinuation symptoms seems to be warranted when discontinuing imipramine, paroxetine, or desvenlafaxine and venlafaxine," the authors write. Abstract/Full Text Editorial (subscription or payment may be required) Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

临床结果临床研究

2024-06-06

·Science Daily

Antidepressants: New data on prevalence of discontinuation symptoms

How hard is it to stop taking antidepressants? If countless Internet posts and a number of scientific studies are to be believed, discontinuing these medications is highly problematic, and doctors often underestimate the difficulties involved. But it is unclear how common discontinuation symptoms actually are. Researchers have now conducted a systematic review and meta-analysis. They conclude that one in three people reports symptoms after discontinuing antidepressant treatment, but half of those symptoms are attributable to negative expectations (the nocebo effect). How hard is it to stop taking antidepressants? If countless Internet posts and a number of scientific studies are to be believed, discontinuing these medications is highly problematic, and doctors often underestimate the difficulties involved. But it is unclear how common discontinuation symptoms actually are. Researchers from Charité -- Universitätsmedizin Berlin and University Hospital Cologne have now conducted a systematic review and meta-analysis. In their article in The Lancet Psychiatry,* they conclude that one in three people reports symptoms after discontinuing antidepressant treatment, but half of those symptoms are attributable to negative expectations (the nocebo effect). According to the formal definition, antidepressants are not habit-forming. Unlike "true" addictive substances, for example, taking them does not cause the body to require higher and higher doses to achieve the same effect. Even so, many patients report symptoms such as dizziness, headache, or insomnia when they stop taking these mood medications. The phenomenon went largely unremarked by researchers for years, but there are now a relatively large number of studies seeking to quantify the extent of discontinuation symptoms. "The results of these studies vary, in some cases widely," says Prof. Christopher Baethge, a researcher at the Department of Psychiatry and Psychotherapy at University Hospital Cologne and the Faculty of Medicine at the University of Cologne. "There has been a great deal of discussion, some of it quite emotional, within the research community and the general public alike in recent years about how prevalent and severe the discontinuation symptoms actually are." A look at prescription figures shows just how relevant this topic is. According to the most recent Arzneiverordnungs-Report, which summarizes data on drug prescriptions, nearly 1.8 billion daily doses of antidepressants were prescribed in Germany in 2022. Comprehensive meta-analysis brings clarity To answer that question more reliably than before, a team led by Christopher Baethge and Dr. Jonathan Henssler, head of the Evidence-Based Mental Health research group at the Department of Psychiatry and Neurosciences at Charité, conducted a systematic review of existing studies and re-analyzed them in what is known as a meta-analysis. As the first study of its kind, it provides the soundest assessment to date of the consequences of stopping antidepressant treatment. "Our analysis shows that on average, one in three people will experience symptoms after stopping antidepressant treatment," Henssler says. "However, only half of these symptoms are in fact attributable to the drug itself." For their paper, the researchers reviewed more than 6,000 studies. They then selected 79 of them and re-analyzed the results of those trials using statistical methods. In the end, they analyzed data on about 21,000 people, who had received either an antidepressant or a placebo and then been surveyed regarding the prevalence of discontinuation symptoms. Some 31 percent of the patients treated with an active drug reported discontinuation symptoms, but so did 17 percent of those who had received a placebo alone. One in six or seven people experiences true discontinuation symptoms "Drug effects can be ruled out in the placebo group, which means the symptoms either arose by chance, independently of the treatment, or they are the product of the nocebo effect," Henssler explains. The nocebo effect is often considered the mirror image of the placebo effect. It explains the observation that inactive treatments can be associated with "side effects." These effects are triggered purely by the expectation that the treatment that people think they are receiving will have negative effects. "When we take non-specific symptoms and the effect of expectations into account, about one in six or seven people is affected by discontinuation symptoms that occur as an actual consequence of antidepressant medication," Henssler says, summing up the study's results. "In most cases, the symptoms are mild. The vast majority of those affected will be able to discontinue antidepressants without relevant symptoms. This means that in most cases, there is no need for a lengthy or gradual tapering process." Severe symptoms are rare The study found that severe discontinuation symptoms are experienced by one in 35 people, or nearly three percent of those affected. These kinds of symptoms were more common after discontinuing treatment with the drugs imipramine, paroxetine, venlafaxine, and desvenlafaxine. There was not yet enough information on hand for the researchers to assess the situation for a number of widely used antidepressants. As Baethge points out, "It's important for all people wishing to discontinue treatment with antidepressants to be monitored and counseled by healthcare professionals and to receive individual support in the case of withdrawal symptoms. Joint decision-making between the patient and prescriber even before a course of treatment begins is the foundation of good treatment. We hope our data will support patients and healthcare professionals and help alleviate some of the uncertainty surrounding these issues today." About the study The 79 studies considered in the meta-analysis included both randomized placebo-controlled trials and observational studies conducted without a control group. Of the 21,002 patients involved in the studies, 16,532 had received an antidepressant, and 4,470 a placebo. In addition to the researchers from Charité and University Hospital Cologne, researchers at the Medical Center -- University of Freiburg and University Hospital Carl Gustav Carus, in Dresden, were involved in the meta-analysis.

临床结果

100 项与富马酸酯去甲文拉法辛相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
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重度抑郁症	美国	Teva Pharmaceuticals USA, Inc.	2013-10-11

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00798707 \| NCT00300378 \| NCT00384033 \| NCT01432457 \| NCT00277823 \| NCT00824291 \| NCT01121484 \| NCT00072774 \| NCT00863798 (Pubmed \| J Clin Psychopharmacol)	N/A	抑郁症	4,317	Placebo	選鏇鬱艱糧窪夢淵憲獵(構衊築簾顧築鑰艱製鏇) = 壓鹹窪範鹽繭繭廠衊夢蓋糧顧糧願憲選醖簾遞 (醖壓餘襯憲夢構鬱選觸 ) 更多	-	2021-06-28
				Desvenlafaxine	選鏇鬱艱糧窪夢淵憲獵(構衊築簾顧築鑰艱製鏇) = 願鏇窪鏇艱簾範夢鬱憲蓋糧顧糧願憲選醖簾遞 (醖壓餘襯憲夢構鬱選觸 ) 更多
NCT01803711 (CTgov)	临床2/3期	心血管疾病 \| 糖尿病 \| 肿瘤 ... 更多	6	Omega 3 Fatty acids+Desvenlafaxine (Desvenlafaxine + Omega 3 FA Supplement)	艱憲繭顧夢積襯顧選鹹(觸鬱壓願廠積淵鏇積夢) = 顧衊壓遞鹽壓構餘蓋醖憲醖壓糧淵願艱鏇築製 (艱鹹製簾鹽鹽鹽選積鬱, 糧壓窪鬱築獵鹹範鏇構 ~ 糧糧鹽繭壓製範鬱鹽糧) 更多	-	2017-12-27
				Placebo (for Omega 3 fatty acid supplement)+Desvenlafaxine (Desvenlafaxine + Placebo (for Omega 3 FA Supplement))	艱憲繭顧夢積襯顧選鹹(觸鬱壓願廠積淵鏇積夢) = 廠餘築鹽淵齋築鹽糧繭憲醖壓糧淵願艱鏇築製 (艱鹹製簾鹽鹽鹽選積鬱, 鬱廠網廠鏇獵鬱願襯淵 ~ 鏇築糧遞衊窪鬱製鑰膚) 更多
NCT01537068 (CTgov)	临床4期	抑郁症	59	Desvenlafaxine (Desvenlafaxine)	顧鑰夢鏇觸餘網製鏇衊(醖簾鹽淵鏇鏇憲蓋選齋) = 鹽繭觸築簾鬱鹹製鏇蓋齋鹽築鹹網糧鑰艱蓋鹹 (醖夢積鑰糧獵膚鹹壓廠, 醖餘窪衊蓋網範顧鹽淵 ~ 鬱廠蓋製夢齋網繭選積) 更多	-	2017-09-11
				Placebo (Placebo)	顧鑰夢鏇觸餘網製鏇衊(醖簾鹽淵鏇鏇憲蓋選齋) = 鹹醖鹹顧衊選顧製獵窪齋鹽築鹹網糧鑰艱蓋鹹 (醖夢積鑰糧獵膚鹹壓廠, 艱壓鏇鹹鹹艱製獵鹹鏇 ~ 觸選鬱艱範醖積醖顧製) 更多
NCT01468610 (Pubmed \| J Affect Disord)	N/A	重度抑郁症	36	Desvenlafaxine 50-100mg/day	憲積鑰鹽顧齋廠憲製鹽(齋獵衊繭襯鏇鹽膚積築) = 築積鏇糧獵觸製艱窪夢範鹽憲衊構繭構糧艱廠 (鏇鏇淵衊簾膚淵鏇製膚 ) 更多	-	2016-10-01
Pubmed \| Curr Med Res Opin	N/A	重度抑郁症	-	Desvenlafaxine 10mg/day or greater	艱簾簾鹹齋鹽製淵遞鑰(願繭艱願觸襯願遞憲選) = 範選淵鹽餘積範鹹壓積鏇鬱鹹繭顧遞獵積鬱壓 (窪選範築網壓夢醖獵鬱 )	-	2015-04-03
				Placebo	艱簾簾鹹齋鹽製淵遞鑰(願繭艱願觸襯願遞憲選) = 壓範範鹽襯鏇鬱願齋鑰鏇鬱鹹繭顧遞獵積鬱壓 (窪選範築網壓夢醖獵鬱 )
Pubmed	N/A	意识障碍	-	Desvenlafaxine 50 mg/d	鹹鹹網願築製膚餘獵衊(艱壓獵蓋網膚廠衊淵衊) = 鏇構繭膚糧壓製選壓簾選鹹獵遞窪鬱觸糧製獵 (鏇窪鬱範觸繭淵餘齋蓋 )	-	2015-01-01
				Desvenlafaxine 100 mg/d	鹹鹹網願築製膚餘獵衊(艱壓獵蓋網膚廠衊淵衊) = 築壓選壓鬱願鹽遞鹹醖選鹹獵遞窪鬱觸糧製獵 (鏇窪鬱範觸繭淵餘齋蓋 )