paroxetine / Generic mfg. - LARVOL DELTA

BNT326-01: A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors (clinicaltrials.gov) - P1/2 | N=980 | Recruiting | Sponsor: BioNTech SE | N=550 ➔ 980 | Trial completion date: Feb 2030 ➔ Oct 2029 | Trial primary completion date: May 2028 ➔ Feb 2028

Enrollment change • Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Hepatocellular Cancer • Lung Cancer • Melanoma • Mucosal Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Renal Cell Carcinoma • Solid Tumor • Triple Negative Breast Cancer • ALK • BRAF • HER-2

Model-informed precision dosing of paroxetine to optimize individualized therapy in patients with mental disorders. (PubMed, J Affect Disord) - "Based on clinical data and reported toxicity cases, a laboratory alert concentration of 350 μg/L is suggested to ensure an adequate safety margin. Overall, this study refines the paroxetine therapeutic reference range by incorporating dose- and sex-specific guidance to support more precise therapeutic drug monitoring (TDM) and promote individualized treatment, particularly at a dosage of 60 mg."

Journal • CNS Disorders • Mental Retardation • Psychiatry

Temporal Patterns of Adverse Events Associated With Selective Serotonin Reuptake Inhibitors: A Global Pharmacovigilance Analysis of Early-Onset Versus Late-Onset Toxicity. (PubMed, Cureus) - "Objective This study aims to explore the timing of AEs associated with six commonly used SSRIs: sertraline, fluoxetine, fluvoxamine, paroxetine, citalopram, and escitalopram using global pharmacovigilance data, with a focus on early- versus late-onset profiles. Early-onset symptoms require timely management to improve tolerability, while late-onset effects highlight the need for ongoing monitoring. These findings can inform personalized monitoring strategies and guide patient counseling to support safer long-term SSRI use."

Adverse events • Journal • CNS Disorders • Dermatology • Diabetes • Insomnia • Metabolic Disorders • Osteoporosis • Rheumatology • Sexual Disorders • Sleep Disorder

Left hand sleep masturbation in a right-handed male patient with sexsomnia. (PubMed, Sleep Med) - "Treatment with gabapentin did not alleviate sexsomnia and triggered obstructive sleep apnea, which improved when the treatment was replaced with paroxetine. The effect of paroxetine on sexsomnia was unknown. This case supports the concept of automatic behavior in sexsomnia."

Journal • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Prediction of 12-Week Remission in Patients With Depressive Disorder Using Reasoning-Based Large Language Models: Model Development and Validation Study. (PubMed, JMIR Ment Health) - "We analyzed data from 390 patients in the MAKE Biomarker discovery study who were undergoing first-step antidepressant monotherapy with 12 different medications, including escitalopram, paroxetine, sertraline, duloxetine, venlafaxine, desvenlafaxine, milnacipran, mirtazapine, bupropion, vortioxetine, tianeptine, and trazodone, after excluding those with uncommon medications (n=9) or missing biomarker data (n=32). Clinical evaluation by psychiatrists showed favorable mean ratings for correctness (4.3, SD 0.7), consistency (4.2, SD 0.8), specificity (4.2, SD 0.7), helpfulness (4.2, SD 1.0), and human likeness (3.6, SD 1.7) on 5-point scales. These findings demonstrate that reasoning-based LLMs, particularly when enhanced with research-informed prompting, show promise for predicting antidepressant response and could serve as interpretable adjunctive tools in depressive disorder treatment planning, although prospective validation in real-world clinical settings remains..."

Journal • CNS Disorders • Depression • Mood Disorders • Psychiatry

Clinical study of the ability of celecoxib combined with olanzapine and paroxetine hydrochloride to improve depression,anxiety and analgesic effects in patients after hemorrhoidal surgery (ChiCTR) - P=N/A | N=60 | Completed | Sponsor: Affiliated Hospital of Jining Medical University; Affiliated Hospital of Jining Medical University

New trial • CNS Disorders • Depression • Gastroenterology • Pain • Psychiatry

The exploration of the efficacy and possible mechanisms of paroxetine combined with liraglutide in the treatment of depression associated with obesity. (ChiCTR) - P=N/A | N=24 | Not yet recruiting | Sponsor: Zhongda Hospital Affiliated to Southeast University; Zhongda Hospital Affiliated to Southeast University

New trial • CNS Disorders • Depression • Genetic Disorders • Mood Disorders • Obesity • Psychiatry

Drug-related suicidal events in children and teenagers: Age-stratified insights from FAERS. (PubMed, Leg Med (Tokyo)) - "Across FAERS youth suicide reports, drug-associated fatality risk varies markedly by drug, surges in mid- to late adolescence, diverges by sex and shifts at both age extremes. These heterogeneities underscore the need for age-appropriate pharmacovigilance and trial strategies rather than direct extrapolation from adult data, particularly regarding the safety of drugs associated with suicide."

Journal • Pediatrics

Paroxetine repurposing enhances antitumor immunity via SPOP-mediated PD-L1 ubiquitination and proteasomal degradation. (PubMed, J Exp Clin Cancer Res) - No abstract available

Journal • Oncology • Targeted Protein Degradation • PD-L1 • SPOP

BMGC-5: Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation (clinicaltrials.gov) - P=N/A | N=120 | Recruiting | Sponsor: Boston Medical Group | Trial completion date: Sep 2025 ➔ Jun 2026 | Trial primary completion date: Jun 2025 ➔ Apr 2026

Trial completion date • Trial primary completion date • Sexual Disorders

Subgenual anterior cingulate cortex and antidepressant response to serotonergic and glutamatergic pharmacological treatments: a systematic review of neuroimaging studies. (PubMed, Prog Neuropsychopharmacol Biol Psychiatry) - "Three metabolic imaging studies reported decreased sgACC metabolism post-treatment with fluoxetine and paroxetine, whereas two serotonin transporter (SERT) occupancy studies reported increased SERT occupancy post-treatment with escitalopram. Future studies should explore individual variability in sgACC modulation, possibly examining genetic, neurobiological, and clinical factors that influence sgACC response to antidepressant pharmacotherapy."

Journal • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Paroxetine Treatment During Prenatal Depression Leads to Sex-Dependent Behavioural Changes, Antioxidant and Neurochemical Impairments in Offspring of Mice. (PubMed, Int J Dev Neurosci) - "Males had decreased GAD enzymes in the hippocampus and striatum; females had low striatal GAD but increased levels in the hippocampus compared to CUMS-exposed offspring, along with sex-dependent regional changes with paroxetine, which increases dopamine and serotonin in the prefrontal cortex, striatum and hippocampus. Our findings indicate that prenatal paroxetine exposure during depression may affect offspring neurodevelopment, causing sex-dependent behavioural, antioxidant and neurochemical impairments."

Journal • Preclinical • CNS Disorders • Depression • Mood Disorders • Psychiatry

Case Report: A case of drug-induced pancreatitis caused by paroxetine with a literature review. (PubMed, Front Med (Lausanne)) - "She was discharged on trazodone and remains recurrence-free. Clinicians should consider DIP in patients lacking traditional risk factors, especially after self-rechallenge. Early recognition, immediate drug cessation and supportive therapy ensure excellent recovery."

Journal • CNS Disorders • Depression • Dyslipidemia • Immunology • Pain • Pancreatitis • Psychiatry

Clinical efficacy and effects on hypothalamic-pituitary-adrenal axis function of proscar combined with selective serotonin reuptake inhibitor in post-stroke depression. (PubMed, World J Psychiatry) - "Combining SSRIs with Free San can enhance therapeutic efficacy, improve depressive symptoms, and regulate HPA axis function in patients with PSD with good safety and clinical application value."

Journal • Cardiovascular • CNS Disorders • Depression • Mood Disorders • Psychiatry

Repurposing the SSRI paroxetine increases lymphocyte mobilization and improves the efficacy of measles virus-based immunovirotherapy. (PubMed, Mol Ther Oncol) - "Furthermore, repurposing paroxetine, one of the Food and Drug Administration-approved selective serotonin reuptake inhibitors (SSRIs) with GRK-2 inhibitory action, enhanced this effect, leading to greater lymphocyte circulation, activation, and improved survival in an orthotopic syngeneic mouse model. By overcoming key mechanisms of immune suppression and repurposing a widely available, clinically safe drug, this strategy represents a highly translatable approach to enhancing the efficacy of immunovirotherapy for gliomas."

IO biomarker • Journal • Brain Cancer • Glioblastoma • Glioma • Infectious Disease • Measles • Oncology • Solid Tumor • S1PR1 • TIGIT

The Efficacy of Combination Therapy With SWTX Capsule and Paroxetine for Depression: A Randomized Controlled Trial. (PubMed, Health Sci Rep) - P=N/A | "Combining SWTX capsule with paroxetine might help maintain paroxetine blood concentration within the optimal range of 20-65 ng/mL, which could potentially lead to better alleviation of depressive symptoms and may reduce adverse reactions compared to paroxetine monotherapy, possibly enhancing overall treatment safety. Trial Registration: Trial was registered in the China Registry of Clinical Trials (Registration ChiCTR2500110909)."

Journal • CNS Disorders • Depression • Mood Disorders • Psychiatry

Lux4UA: Building Ukraine's Strength in PTSD Treatment and Research (clinicaltrials.gov) - P=N/A | N=120 | Recruiting | Sponsor: University of Luxembourg | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

An open-label, single-arm, dose-escalating concentration-QT study to investigate the cardiac effects and safety of paroxetine in healthy adults. (PubMed, Br J Clin Pharmacol) - P1 | "Paroxetine does not prolong QTc interval in healthy individuals to any clinically meaningful extent at therapeutically relevant doses. This study supports the favourable cardiac safety profile of paroxetine."

Journal • CNS Disorders • Depression • Heart Failure • Major Depressive Disorder • Mood Disorders • Psychiatry

Sinapic acid balances the excitatory and inhibitory neurotransmitter systems to mitigate post-traumatic stress disorder-like behaviors. (PubMed, Life Sci) - "Notably, in the case of cognitive dysfunction, paroxetine failed to improve, but sinapic acid restored cognitive function...The mitigation of fear memory deficits by sinapic acid was exerted by sub-effective dose of GluN2B-containing NMDA receptor antagonist and abolished by GABAA receptor antagonist. Our findings suggest that sinapic acid could serve as a potential therapeutic agent for PTSD by balancing excitatory and inhibitory neurotransmitter systems due to its action on GluN2B-containing NMDA receptors and GABAA receptors."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Mood Disorders • Post-traumatic Stress Disorder • Psychiatry • GRIN2B

Efficacy and safety of AVIANDR in the treatment of panic disorder: results of the first stage of the multicenter, randomized, placebo-controlled study (PubMed, Zh Nevrol Psikhiatr Im S S Korsakova) - "Aviandr demonstrated statistically significant superiority over placebo, rapid onset of action, and a favorable safety profile, making it a promising treatment option for panic disorder."

Clinical • Journal • CNS Disorders • Mood Disorders • Psychiatry

MDD: Neurobiological and Genomic Predictors of Relapse in Depression (clinicaltrials.gov) - P=N/A | N=204 | Recruiting | Sponsor: Mehmet Kemal Arikan

New trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Fate, chlorination kinetics, and comprehensive risk assessment of pharmaceuticals and personal care products in drinking water distribution systems. (PubMed, J Contam Hydrol) - "Four compounds (atenolol, sulpiride, paroxetine, and nadolol) exhibited pseudo-first-order kinetics with residual chlorine, while the others exhibited significant resistance to chlorination...Ecological risk assessment revealed ibuprofen posed a moderate ecological risk, a risk quotient (RQ) of 0.335, while triclocarban presented a high ecological risk (RQ = 4.6031)...Among the detected PPCPs, meclofenamic acid was identified as the compound of highest concern, with average relative risk indices exceeding >10-4. These findings provide critical insights into the fate and transformation of PPCPs in drinking water systems and offer scientific guidance for optimizing treatment processes and risk management strategies."

Journal

Comparative Real-World Safety Profiles of Six Selective Serotonin Reuptake Inhibitors: A Global Pharmacovigilance Analysis. (PubMed, Cureus) - "Methods We conducted a comprehensive pharmacovigilance analysis utilizing VigiBase, the WHO global database of individual case safety reports, encompassing over 342,000 reports for six major SSRIs (sertraline, fluoxetine, paroxetine, citalopram, escitalopram, and fluvoxamine). Conclusions This analysis reveals that SSRIs exhibit distinct safety profiles that correlate with their pharmacodynamic properties, challenging the traditional view of these medications as a homogeneous therapeutic class. These findings support precision prescribing approaches based on individual patient risk factors and provide mechanistic insights for evidence-based SSRI selection."

Adverse events • Journal • Real-world evidence • CNS Disorders • Sexual Disorders • Sleep Disorder

Nocturnal sleep-related scratching disorder as a possible variant of NREM arousal disorder: Clinical features and polysomnographic study of four newly reported cases. (PubMed, Sleep Med X) - "Paroxetine, 20 mg with clonazepam as (0.5-1.0 mg) at bedtime induced 50 % efficacy. 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."

Journal • CNS Disorders • Dental Disorders • Depression • Fibrosis • Major Depressive Disorder • Psychiatry • Sexual Disorders • Sleep Disorder

A Comparison of Prolonged Exposure Therapy, Pharmacotherapy, and Their Combination for PTSD (clinicaltrials.gov) - P4 | N=302 | Active, not recruiting | Sponsor: University of Pennsylvania | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder