Introduction The consumption of antidepressants has increased considerably worldwide, including in Spain. Despite their effectiveness in cases of moderate to severe depression, their long-term use in mild cases is questioned. This study aims to evaluate the effectiveness of a deprescribing intervention in primary care, to reduce the unnecessary consumption of these drugs and improve patients' quality of life.
Material and Methods A community-based clinical trial will be carried out before and after in an adult population of residents of an urban area of Cadiz (Spain) who have been prescribed antidepressants in the last year. Participants will be randomly selected and followed up for a predetermined period after consensus.
The intervention will consist of a comprehensive evaluation of antidepressant treatment by a team of health professionals. Factors such as indication, dose, and response to treatment will be evaluated, and the Hamilton scale for anxiety and the Beck Inventory for depression will be used. In those cases where it is considered appropriate, a gradual reduction or suspension of the drug will be proposed, always under medical supervision.
Conclusions This research will contribute to generating scientific evidence on the safety and efficacy of deprescribing in primary care, promoting a more rational use of antidepressants, and improving the quality of life of patients. The results obtained could have important implications for clinical practice and for the development of clinical practice guidelines.

Start Date01 Jun 2026

Sponsor / Collaborator

Universidad De Huelva

NCT03329573

/ CompletedPhase 1

Randomized, Open Label, 2-way Crossover, Single Dose Bioequivalence Study of Paroxetine IR Tablets Manufactured in GSKT and Mississauga Sites in Healthy Chinese Participants Under Fasting and Fed Conditions

Paroxetine is a selective serotonin reuptake inhibitor (SSRI) and paroxetine IR tablets have been approved for the treatment of three anxiety indications in China. This bioequivalence study will evaluate Paroxetine IR tablets manufactured in GSKT (A) and Mississauga (B) sites in healthy Chinese subjects under fasting and fed conditions to support the quality consistency evaluation. This is a single dose, open-label, randomized, two-period crossover study and will include a screening period (up to 7 days), two open-label treatment periods (up to 16 days) and a follow-up phase (up to 14 days after last-dose). The whole study will be divided into two groups, one for fasting condition enrolling approximately 36 subjects and another for fed condition for which approximately 44 subjects will be enrolled. In both groups, eligible subjects will be randomized to receive single dose of Paroxetine IR tablets A or B in a cross-over manner.

Start Date30 May 2018

Sponsor / Collaborator

GSK Plc

CTR20180128

/ Completed

盐酸帕罗西汀肠溶缓释片在健康成年受试者中的随机开放单次给药三周期部分重复交叉餐后状态下生物等效性试验

[Translation] A randomized, open-label, single-dose, three-period, partially repeated crossover bioequivalence study of paroxetine hydrochloride enteric-coated sustained-release tablets in healthy adult subjects under fed conditions

本试验目的是以深圳信立泰药业股份有限公司提供的盐酸帕罗西汀肠溶缓释片（25mg/片）为受试制剂，按有关生物等效性试验的规定，与GlaxoSmithKline 生产的盐酸帕罗西汀肠溶缓释片（商品名：赛乐特®CR，规格：25mg/片，参比制剂）进行人体生物利用度与生物等效性试验。观察受试制剂盐酸帕罗西汀肠溶缓释片和参比制剂赛乐特®CR在健康受试者中的安全性。

[Translation]

The purpose of this study is to use the paroxetine hydrochloride enteric-coated sustained-release tablets (25 mg/tablet) provided by Shenzhen Xinlitai Pharmaceutical Co., Ltd. as the test preparation, and conduct human bioavailability and bioequivalence tests with the paroxetine hydrochloride enteric-coated sustained-release tablets (trade name: Seroxetine® CR, specification: 25 mg/tablet, reference preparation) produced by GlaxoSmithKline according to the relevant provisions of bioequivalence tests. The safety of the test preparation paroxetine hydrochloride enteric-coated sustained-release tablets and the reference preparation Seroxetine® CR in healthy subjects was observed.

Start Date28 Feb 2018

Sponsor / Collaborator

Shenzhen Salubris Pharmaceuticals Co., Ltd.

100 Clinical Results associated with Paroxetine Mesylate

100 Translational Medicine associated with Paroxetine Mesylate

100 Patents (Medical) associated with Paroxetine Mesylate

7,213

Literatures (Medical) associated with Paroxetine Mesylate

01 Jan 2027·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Xiaoyao San exerts antidepressant effects via the gut microbiota-brain axis: An integrative fMRI and multiomics study

Article

Author: Kuang, Shanshan ; Gao, Tingting ; Zheng, Ruise ; Lv, Zhiping ; Huang, Sha ; Mo, Chan ; Chen, Qing ; Wen, Jinjie ; Li, Siying ; Li, Lan ; Fu, Shanshan ; Wang, Yuhua

Depression is characterized by a dysregulated brain-gut axis. Xiaoyao San (XYS), a classic Traditional Chinese Medicine formula for soothing Liver and strengthening Spleen, is clinically effective in alleviating depression. However, the systems-level mechanisms by which XYS coordinates gut-brain communication to exert its antidepressant effects remain insufficiently understood. This study aimed to systematically elucidate the antidepressant mechanisms of XYS, with a focus on identifying a key gut-derived metabolic pathway that modulates prefrontal cortex (PFC) function. A mouse model of depression was established using isolated housing combined with chronic unpredictable mild stress (CUMS). Mice were treated with XYS at low, medium, and high doses or paroxetine. We employed a multimodal approach, integrating behavioral tests, resting-state functional magnetic resonance imaging (rs-fMRI), gut microbiota profiling (16S rRNA sequencing), serum metabolomics and PFC transcriptomics. To establish causal evidence, pseudo-germ-free mice received fecal microbiota transplantation (FMT) from donor mice treated with XYS, followed by comprehensive behavioral and biochemical assessments. XYS treatment significantly ameliorated depressive-like behaviors and restored functional connectivity within emotion-regulation brain networks. Multi-omics integration revealed that XYS reshaped the gut microbiota, which was associated with a reduction in systemic levels of kynurenine (KYN), a key tryptophan-derived metabolite. In the PFC, this decrease in KYN was accompanied by the normalization of aryl hydrocarbon receptor (AhR) signaling activity. Furthermore, GABAergic neurotransmission, mediated by γ-aminobutyric acid (GABA), was enhanced, as evidenced by upregulated expression of glutamate decarboxylase 1 (Gad1), gamma-aminobutyric acid type A receptor subunit alpha1 (Gabra1), increased GABA content, and elevated levels of key synaptic plasticity-related molecules, including brain-derived neurotrophic factor (BDNF), postsynaptic density protein-95 (PSD-95), and synaptophysin (SYN). Critically, FMT from XYS-treated donors recapitulated the antidepressant phenotype in recipient mice, directly implicating the gut microbiota in these therapeutic effects. This study demonstrates that XYS alleviates depression by orchestrating a gut-brain signaling cascade that converges on the PFC to enhance inhibitory synaptic transmission. These findings provide novel and causal mechanistic insights into the brain-gut modulatory action of XYS, offering a comprehensive framework for its therapeutic potential in treating depression.

31 Dec 2026·REDOX REPORT

Redox modulation contributes to the antidepressant-like and neuroprotective effects of 7-chloro-4-(phenylselanyl)quinoline in an Alzheimer’s disease model

Article

Author: Dos S Barboza, Victor ; Da C Rodrigues, Karline ; Lima, Ariana Silveira ; De A Vaucher, Rodrigo ; Savegnago, Lucielli ; Fidelis, Eduarda M ; Giongo, Janice L ; Luchese, Cristiane ; Alves, Diego ; De Oliveira, Renata L ; Quines, Caroline B ; Vogt, Ane G ; Pinz, Mikaela P ; Pinton, Simone ; Voss, Guilherme T

OBJECTIVES:

Alzheimer's disease (AD) is characterized by cognitive impairment and neuropsychiatric disturbances, including depression, both tightly linked to redox imbalance and neuroinflammatory activation. This study investigated whether the selenium-containing compound 7-chloro-4-(phenylselanyl)quinoline (4-PSQ) mitigates behavioral and biochemical alterations in a β-amyloid (Aβ)-induced mouse model of AD through modulation of redox-regulated pathways.

METHODS:

Male Swiss mice received intracerebroventricular Aβ (25-35) or saline (3 µL/site) and were treated orally for seven days with 4-PSQ (1 mg/kg), paroxetine (1 mg/kg), or donepezil (1 mg/kg). Depressive-like behavior and memory performance were assessed, followed by determination of plasma corticosterone, reactive species levels, lipid peroxidation, antioxidant enzyme activities, neuroinflammatory mediators, and acetylcholinesterase (AChE) activity in the hippocampus and prefrontal cortex of mice.

RESULTS:

4-PSQ significantly reversed Aβ-induced depressive behavior and memory impairment. The compound normalized plasma corticosterone levels, reduced reactive species and lipid peroxidation, and restored antioxidant enzyme activity. It also decreased the expression of inflammatory markers while regulating AChE activity, indicating concomitant modulation of redox, neuroimmune, and cholinergic pathways.

CONCLUSION:

By restoring redox homeostasis and attenuating neuroinflammatory responses, 4-PSQ effectively counteracted behavioral and biochemical disruptions associated with Aβ toxicity. These findings support 4-PSQ as a promising selenium-based therapeutic candidate targeting redox-driven features of AD, including comorbid depression and cognitive decline.

01 Dec 2026·Sleep medicine: X

Nocturnal sleep-related scratching disorder as a possible variant of NREM arousal disorder: Clinical features and polysomnographic study of four newly reported cases

Article

Author: Schenck, Carlos H ; Gómez Morales, María Fernanda ; Sinning, Nicole Cresp

A clinical variant of NREM arousal disorder is described manifesting with predominantly injurious, and exclusively sleep-related scratching without any conscious awareness, and without a history of dermatologic disease. Four patients were clinically evaluated and underwent videopolysomnography (vPSG). Case 1, a 30-year-old woman had a 20-yr history of non-injurious arm scratching/rubbing during sleep. vPSG: forearm rubbing against the chin during N2/N3. Two years later she developed restless bladder symptoms and leg movements before sleep onset. Serum ferritin level: 20.7 Intravenous iron therapy resulted in full control of bedtime leg movements, restless bladder symptoms, and nocturnal scratching. Case 2, a 28-year-old married man had a 1.5-yr history of perianal scratching with excoriations/bleeding during sleep, without other parasomnia. Medical and dermatologic evaluations were negative. vPSG: arousal index of 34/hr, with multiple episodes of perianal scratching. Paroxetine, 20 mg with clonazepam as (0.5-1.0 mg) at bedtime induced 50 % efficacy. Case 3, a 26-year-old African-American female had NREM parasomnias, vigorous sleep-related scratching with keloid formation, and major depression. Medical history was negative. vPSG: arousal index: 28/hr, without abnormal behaviors. Multiple sleep latency test (MSLT): mean sleep latency, 3.6 min, no REM sleep. Idiopathic hypersomnia and NREM parasomnias were diagnosed. Sleep-related scratching and NREM parasomnias responded fully to bedtime clonazepam, 0.5 mg. Case 4, a 50-year-old female had longstanding injurious sleep-related scratching, sleep terrors, and sleep bruxism. vPSG: 55 % sleep efficiency; arousal index: 25/hr, without abnormal behaviors or apneas. MSLT: no objective sleepiness. These cases of sleep-related scratching disorder represent a heterogeneous presumed variant of NREM arousal disorder with various comorbidities, and with full/partial control from diverse therapies.

News (Medical) associated with Paroxetine Mesylate

19 Feb 2026

·www.einpresswire.com

Palisades Therapeutics Receives FDA Clearance to PROCEED with Phase 2a PTSD Trial of PT150 in U.S. Veterans

DoD-Funded Study Accelerates Novel PTSD Mechanism into Trials; Proven Alcohol Safety Profile De-Risks Program for Patients with Comorbid Alcohol Use Disorder PT150 offers a rare, dual-validated opportunity, backed by both DoD and NIAAA, creating a highly de-risked CNS asset with clear partnering and lifecycle expansion potential.” — Randi Altschul, CEO CLIFFSIDE PARK, NJ, UNITED STATES, February 19, 2026 / EINPresswire.com / -- Pop Test Oncology LLC, operating as Palisades Therapeutics , today announced that the U.S. Food and Drug Administration (FDA) has granted permission to PROCEED with a Phase 2a clinical trial entitled “Efficacy and Safety of PT150 in U.S. Veterans with Post Traumatic Stress Disorder (PTSD)." The dual-site, double-blind, placebo-controlled study is funded by the Department of Defense Congressionally Directed Medical Research Programs and will enroll 120 Veterans at VA medical centers in San Diego, California and Houston, Texas. PT150, an orally dosed selective glucocorticoid receptor (GR) antagonist, represents one of the first novel pharmacological mechanisms investigated for PTSD in over two decades, directly targeting dysregulated stress biology underlying trauma symptomatology and addiction relapse. An Urgent Unmet Need PTSD affects up to 20% of military personnel and approximately 6-8% of the civilian population, yet no new medications have been approved for PTSD since 2001. The disorder's high comorbidity with alcohol use disorder—affecting 30-50% of PTSD patients—creates an urgent clinical challenge. Existing FDA-approved treatments (sertraline and paroxetine) provide limited symptom relief and fail to address shared neurobiological mechanisms driving trauma memory dysfunction and stress-triggered relapse. The impact is staggering: the Veterans Affairs system treats over 1 million Veterans with PTSD annually, while AUD costs the nation over $249 billion in healthcare and productivity losses. This nearly quarter‑century gap in new PTSD medications reflects the complexity of PTSD neurobiology and limitations of traditional monoamine‑based approaches in engaging core stress‑response pathways. PT150: A Novel Mechanism Targeting Stress Biology PT150 addresses this gap by modulating glucocorticoid receptor (GR) signaling, a central component of the hypothalamic-pituitary-adrenal (HPA) axis dysregulation characteristic of PTSD. Evidence suggests that GR hypersignaling disrupts trauma memory consolidation and extinction while increasing vulnerability to stress-triggered relapse. Short-term GR antagonism is hypothesized to "reset" this dysregulated system, normalizing emotional memory processing and stress resilience, potentially improving both core PTSD symptoms and relapse risk. PT150 is part of an extended Palisades Therapeutics platform of next‑generation GR‑modulating compounds designed to address a spectrum of stress‑ and immune‑mediated CNS and systemic disorders. This platform approach supports lifecycle expansion and follow‑on indications for PT150 and related compounds that can be pursued in partnership with leading pharmaceutical companies. Groundbreaking Alcohol Safety Data: De-Risking Development A critical differentiation for PT150 is its validation for populations with active alcohol consumption—a hallmark of PTSD/AUD comorbidity. Palisades Therapeutics has completed two peer-reviewed studies demonstrating PT150 is safe and well-tolerated when co-administered with alcohol: Study 1: Pharmacodynamic Safety (Scientific Reports, 2021) A Phase 1 randomized trial at Michael E. DeBakey VA Medical Center evaluated safety and pharmacodynamic interactions between PT150 and ethanol in healthy, alcohol-experienced volunteers. Key findings included: • No significant differences in vital signs (heart rate, blood pressure) during alcohol challenges • No clinically significant electrocardiogram changes or serious adverse events • No meaningful differences in alcohol craving or subjective intoxication Conclusion: "Administration of PT150 with concurrent alcohol use is safe and well-tolerated." Study 2: Pharmacokinetic Interactions (Journal of Addiction Medicine, 2025) A Phase 1 drug-drug interaction study evaluated whether ethanol alters PT150 pharmacokinetics or vice versa. Rigorous analysis of peak plasma concentrations (Cmax), time to peak (Tmax), elimination half-life (t½), and area under the concentration curve (AUC) revealed: • No statistically significant PK interactions between PT150 and ethanol on any parameter • No serious adverse events or abnormal electrocardiograms Conclusion: "Coadministration of PT150 and alcohol does not produce significant pharmacokinetic interactions, supporting feasibility of evaluating PT150 in future clinical trials for alcohol use disorder." This alcohol safety profile is unprecedented among novel CNS therapeutics and positions PT150 as uniquely suited for Veteran populations and civilians with PTSD/AUD comorbidity, where active alcohol use is prevalent. Dual Government-Validated Development Pathway The FDA-cleared PTSD trial complements ongoing National Institute on Alcohol Abuse and Alcoholism (NIAAA)-funded Phase 2 research at the University of Kentucky, now in its second year of enrollment. This dual government backing—DoD for PTSD, NIAAA for AUD—provides exceptional de-risking for prospective pharmaceutical partners, as both federal agencies have independently validated the clinical rationale and study designs supporting PT150's development. Phase 2a PTSD Trial Design Study Endpoints: • Primary: Change in PTSD symptoms from baseline to 4 weeks post-treatment (Clinician Administered PTSD Scale for DSM-5) • Secondary: Safety and tolerability (Frequency, Intensity, Burden of Side Effects rating scale) • Exploratory: Fear potentiated startle extinction/recall testing, a PTSD-specific biomarker sensitive to glucocorticoid signaling Study Leadership: • Principal Investigator: Victoria Risbrough, Ph.D., VA Research Career Scientist, Professor and Vice Chair of Academic Affairs in Psychiatry at University of California San Diego • Co-Investigator: Christopher D. Verrico, Ph.D., Michael E. DeBakey VA Medical Center and Baylor College of Medicine; more than 20 years of experience in addiction pharmacology • Consulting Team: Dr. Dewleen Baker (PTSD researcher, former Director of Neuroscience, San Diego CESAMH); Dr. Thomas R. Kosten (Waggoner Chair, Psychiatry/Neuroscience/Pharmacology, Baylor); Dr. Katia Harlé (lead biostatistician, UCSD) • Laboratory support provided by TPM Laboratories, Inc., a Cormica Lab Platform Opportunity Beyond PTSD While PTSD and AUD are the initial focus, PT150 has demonstrated preliminary efficacy signals in multiple CNS and systemic indications including neurodegeneration (Parkinson's disease models), glioblastoma, and GLP-1 adjunctive therapy for metabolic set-point modulation. "PT150 offers a rare, dual-validated opportunity: a novel GR-targeted mechanism in PTSD with an unprecedented alcohol safety package, backed by both DoD and NIAAA, creating a highly de-risked CNS asset with clear partnering and lifecycle expansion potential." said Randi Altschul, CEO of Palisades Therapeutics About Palisades Therapeutics Pop Test Oncology LLC, operating as Palisades Therapeutics, is a clinical-stage pharmaceutical company developing novel therapeutics for CNS disorders, oncology, and metabolic diseases. The company operates as a "brain trust" of 100+ scientists, physicians, and professionals collaborating across leading academic institutions and federal agencies. Forward-Looking Statements This press release contains forward-looking statements regarding PT150 development, trial outcomes, and commercial potential. These statements are based on current expectations and involve risks and uncertainties. Randi Altschul Pop Test Oncology/Palisades Therapeutics +1 201-943-3770 email us here Visit us on social media: LinkedIn Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Phase 2Phase 1

30 Jan 2026

·www.einpresswire.com

Alternative to Meds Center Provides Clinical Education on Paxil Withdrawal and Individualized Discontinuation Support

Understanding Paxil withdrawal symptoms, tapering considerations, and patient-specific care Because paroxetine leaves the body quickly, even small dose changes or missed doses can trigger noticeable symptoms. This is why individualized tapering and close monitoring are so important.” — Alternative to Meds Center SEDONA, AZ, UNITED STATES, January 30, 2026 / EINPresswire.com / -- Alternative to Meds Center, a licensed residential mental health treatment facility located in Sedona, Arizona, is providing clinical education on Paxil (paroxetine) withdrawal, a frequently challenging experience for individuals seeking to discontinue selective serotonin reuptake inhibitor (SSRI) antidepressant medications. Paxil, known generically as paroxetine, is prescribed for a range of mental health conditions, including major depressive disorder, generalized anxiety disorder, panic disorder, social anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder. While many individuals initially experience symptom relief, others find that side effects, tolerance, or diminished benefit over time lead them to consider discontinuation. Clinical evidence shows that stopping paroxetine without appropriate medical guidance can result in significant withdrawal symptoms, particularly due to the medication’s short half-life and strong effect on serotonin regulation. Paroxetine withdrawal, often described as antidepressant discontinuation syndrome, may involve a wide range of physical, neurological, and psychological symptoms. Commonly reported effects include dizziness, nausea, headaches, flu-like symptoms, sleep disturbances, vivid dreams or nightmares, irritability, anxiety, and sensory disturbances such as “brain zaps” or electric shock–like sensations. Some individuals also report mood instability, confusion, panic attacks, or intrusive thoughts during withdrawal. “ Paxil withdrawal can be particularly intense compared to other SSRIs,” said a clinical representative for Alternative to Meds Center. “Because paroxetine leaves the body quickly, even small dose changes or missed doses can trigger noticeable symptoms. This is why individualized tapering and close monitoring are so important.” Medical literature indicates that withdrawal symptoms from paroxetine often begin within one to three days after a dose reduction or discontinuation. While some individuals experience symptoms that resolve within a few weeks, others report prolonged or fluctuating withdrawal lasting several months or longer, particularly after long-term use. In more severe cases, individuals may experience post-acute withdrawal symptoms that require ongoing support. Paroxetine works by blocking the reuptake of serotonin in the brain, increasing its availability in the synapse. Over time, the central nervous system adapts to this altered chemical environment, a process known as neuroadaptation. When the medication is reduced too rapidly or stopped abruptly, serotonin signaling can change suddenly, placing stress on the nervous system and contributing to withdrawal symptoms. Because of this mechanism, abrupt discontinuation is widely discouraged. Alternative to Meds Center emphasizes that withdrawal symptoms are often mistaken for relapse of the original mental health condition. This overlap can lead to misdiagnosis and unnecessary medication escalation. Distinguishing withdrawal physiology from recurrence of symptoms is a critical component of safe and effective care. Side effects are another reason many individuals choose to discontinue Paxil. Reported adverse effects include drowsiness, sexual dysfunction, weight changes, emotional blunting, agitation, and sleep disruption. In some cases, more serious risks such as increased suicidality or serotonin syndrome have been documented, particularly when paroxetine is combined with other serotonergic medications. These risks underscore the importance of informed decision-making and professional oversight. At Alternative to Meds Center, care for Paxil withdrawal focuses on individualized assessment and comprehensive support rather than standardized tapering schedules alone. Treatment planning considers factors such as medication history, physical health, nutritional status, stress physiology, and emotional well-being. Clinical care may include medical monitoring, psychotherapy, nutritional and orthomolecular support, stress-reduction strategies, and integrative therapies designed to support nervous system stability during tapering. The center also recognizes that not everyone requires inpatient treatment to discontinue Paxil. However, individuals who have experienced severe withdrawal symptoms, repeated unsuccessful tapering attempts, or significant functional impairment may benefit from a higher level of care. Choosing practitioners who are familiar with SSRI withdrawal is considered essential to reduce risk and improve outcomes. Located in the red rock region of Sedona, Alternative to Meds Center has nearly two decades of experience helping individuals safely reduce or discontinue psychiatric medications while addressing underlying contributors to mental health distress. The center’s residential programs are staffed by licensed medical and therapeutic professionals and are designed to provide a calm, structured environment focused on long-term recovery rather than short-term symptom suppression. As awareness of antidepressant withdrawal continues to grow, Alternative to Meds Center aims to provide evidence-based education that empowers individuals and families to make informed healthcare decisions. The center encourages anyone considering changes to their medication regimen to seek professional guidance and to avoid abrupt adjustments without medical supervision. More information about Paxil withdrawal, SSRI discontinuation, and available treatment options can be found through Alternative to Meds Center. About Alternative to Meds Center Alternative to Meds Center is a licensed residential mental health treatment facility based in Sedona, Arizona. For nearly 20 years, the center has helped individuals safely reduce or discontinue psychiatric medications while addressing underlying mental health challenges through medical supervision, psychotherapy, nutritional support, and holistic therapies. Alternative to Meds Center Alternative to Meds Center +1 877-503-0770 email us here Visit us on social media: LinkedIn Instagram Facebook YouTube TikTok X Other Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

28 Oct 2025

·www.drugs.com

Antidepressants Vary Significantly in Cardiometabolic Effects

TUESDAY, Oct. 28, 2025 -- Antidepressants induce cardiometabolic and other physiological alterations, which vary between medications, according to a study published online Oct. 21 in The Lancet . Toby Pillinger, Ph.D., from King's College London, and colleagues compared and ranked antidepressants based on physiological side effects using data from randomized controlled trials. A total of 151 studies and 17 U.S. Food and Drug Administration reports met the inclusion criteria. Overall, 58,534 participants were included and 30 antidepressants were compared to placebo. The researchers found that in terms of metabolic and hemodynamic effects, there were clinically significant differences between antidepressants, including an approximate difference of 4 kg in weight change between agomelatine and maprotiline, a difference of more than 21 beats per minute in change in heart rate between fluvoxamine and nortriptyline, and a difference of more than 11 mmHg in systolic blood pressure between nortriptyline and doxepin. Increases in total cholesterol were seen in association with paroxetine , duloxetine , desvenlafaxine , and venlafaxine ; duloxetine was associated with increased glucose concentrations, despite reductions in body weight with all drugs. No strong evidence was found for any antidepressant affecting QTc or concentrations of sodium, potassium, urea, or creatinine to a clinically significant extent. "We found strong evidence that antidepressants differ markedly in their physiological effects, particularly for cardiometabolic parameters," the authors write. "Treatment guidelines should be updated to reflect differences in physiological risk, but choice of antidepressant should be made on an individual basis, considering clinical presentation and preferences of patients, carers, and clinicians." Several authors disclosed ties to the biopharmaceutical industry. Abstract/Full Text

Clinical Result

100 Deals associated with Paroxetine Mesylate

External Link

KEGG	Wiki	ATC	Drug Bank
D05375	Paroxetine Mesylate	N06AB05	DB00715

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Vasomotor symptom	United States	Legacy Pharma, Inc. SEZC	28 Jun 2013
Vasomotor symptom	United States	Legacy Care Partners, Inc.	28 Jun 2013
Generalized anxiety disorder	United States	Sebela Ireland Ltd.	09 Dec 2006
Depressive Disorder, Major	United States	Sebela Ireland Ltd.	03 Jul 2003
Obsessive-Compulsive Disorder	United States	Sebela Ireland Ltd.	03 Jul 2003
Panic Disorder	United States	Sebela Ireland Ltd.	03 Jul 2003

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03329573 (CTgov)	Phase 1	Anxiety Disorders	85	GSKT+Paroxetine (Paroxetine 40 mg, GSKT- Fed)	jfezbhewua(cigpelpmva) = xknboqyxif risyrsxeon (wahxfdybtc, opjdphzfvk - ncrdeqjcrx) View more	-	19 Aug 2019
NCT03329573 (CTgov)	Phase 1	Anxiety Disorders	85	Paroxetine (Paroxetine 40 mg, Mississauga- Fed)	jfezbhewua(cigpelpmva) = nakvdlgjij risyrsxeon (wahxfdybtc, bzzwcpeyxl - faljywdptx) View more	-	19 Aug 2019
NCT01361308 (N30-003, CTgov)	Phase 3	Menopausal syndrome \| Vasomotor symptom	614	Placebo capsules	bessjokvae(cvyxbrweej) = kptwcdogpe aytvkjflef (wtuaftjqws, 4.39) View more	-	20 May 2014
NCT01101841 (CTgov)	Phase 3	Menopausal syndrome \| Hot Flashes \| Vasomotor symptom	570	Placebo capsules	dokpunrblj(myylzfmlbl) = sxmpnpisgg jmldgdpozh (dmpzacfoks, 3.96) View more	-	21 Apr 2014
NCT00786188 (CTgov)	Phase 2	Menopausal syndrome \| Hot Flashes \| Vasomotor symptom	102	sugar pill	pmvztiurby(fgkteqyipt) = arveokhuus brhpntegdy (fkaayqjbhf, 3.67) View more	-	12 Mar 2014
NCT01829919 (N30-005, CTgov)	Phase 1	-	24	Brisdelle (Paroxetine Mesylate) (Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg)	xmuuzzwdsh(rswjclyhzs) = vyurrtfpzh cbuzecszos (zitpbgnmxy, 166.19) View more	-	24 Feb 2014
NCT01829919 (N30-005, CTgov)	Phase 1	-	24	Brisdelle (Paroxetine Mesylate) (Brisdelle (Paroxetine Mesylate) Capsules)	exdybugonn(mdgastcoet) = yntrhagjmm bwyipgkpyr (mvjhxonphf, mxknvscbmq - pryknsxptz) View more	-	24 Feb 2014
NCT01829919 (Pubmed \| Clin Ther)	Phase 1	-	24	LDMP 7.5 mg	qhxkjayumb(dbgmwhspuy) = Most subjects (23/24 [95.8%]) experienced at least 1 treatment-emergent adverse event (AE); however, most AEs (67 events in 22/24 subjects [91.7%]) were mild, and the remainder were moderate. Seventeen subjects experienced 33 AEs that were deemed possibly or probably related to LDMP. No serious AEs were reported, and no clinically meaningful changes in laboratory values, vital signs, or ECGs were observed. psduwyaflr (gaepgoowej )	-	01 Jun 2013

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