paroxetine extended release / Generic mfg. - LARVOL DELTA

Alembic Pharmaceuticals Ltd…said it has received a final approval from the US health regulator for its generic version of Paroxetine extended-release tablets indicated for treatment of depression and anxiety. (Press Trust Of India)

ANDA • Depression • Social Anxiety Disorder

Dissolving microneedle patches for transdermal delivery of paroxetine: in-vitro, ex-vivo studies and its PBPK modeling. (PubMed, Ther Deliv) - "MNPs from the optimized formulation successfully created microchannels in rat skin, demonstrated higher permeation than control MNPs with a flux of 146.18 ± 13.42 µg/cm2/h, presented a decrease in lag phase and an increase in drug plasma Cmax and AUC compared to PAXIL CR 12.5 mg oral, and showed higher stability in the room and refrigerator conditions. The prepared MNPs were stable and can deliver PRX-HCl sufficiently across skin barrier with enhanced bioavailability compared to oral administration at similar doses and thus be a better alternative to already available delivery systems for PRX-HCl."

Journal • Preclinical

Propensity Weighted Approach to Control the Confounding Effect of Unbalanced Distribution of Placebo Responders on the Treatment Effect in Psychiatric Clinical Trials: An Artificial Intelligence Driven Trial Simulation Study (ASCP 2024) - "CTSs were conducted using data from two placebo-controlled 3-arm RCTs to evaluate paroxetine CR (12.5 and 25 mg) in major depressive disorders...These findings emphasize the potential interest of PSW to become the reference approach for analyzing RCTs. Learning Objectives To learn novel methodologies for analyzing clinical trials accounting for excessively low/high placebo response To learn how artificial intelligence can effectively support the analysis of clinical data"

Clinical • Late-breaking abstract • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • CTSS

Propensity Weighting Method to Assess the Treatment Effect in Clinical Trials for Major Depressive Disorders Accounting for Heterogeneous Placebo Effect Using an Artificial Intelligence Approach (ASCP 2023) - "A case study is presented using a randomized, double-blind, placebo-controlled, three-arms, parallel-group, 8 weeks, fixed-dose study to evaluate the efficacy of paroxetine CR at 12.5 and 25 mg/day...To learn novel methodologies for analyzing clinical trial data in MDD accounting for heterogeneous placebo effect 2. To learn how artificial intelligence can effectively support the analysis of clinical data"

Clinical • Heterogeneity • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Artificial intelligence approach for the analysis of placebo-controlled clinical trials in major depressive disorders accounting for individual propensity to respond to placebo. (PubMed, Transl Psychiatry) - "A randomized, double-blind, placebo controlled, three arms, parallel group, 8-week, fixed-dose study to evaluate efficacy of paroxetine CR 12.5 and 25 mg/day is presented as a cases study...The analysis with and without propensity weight indicated that the weighted analysis provided an estimate of treatment effect and effect-size about twice larger than the non-weighted analysis. Propensity weighting provides an unbiased strategy to account for heterogeneous and uncontrolled placebo effect making patients' data comparable across treatment arms."

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

A Trial to Evaluate the Efficacy, Safety & Tolerability of Brexpiprazole in the Maintenance Treatment of Adults With Major Depressive Disorder (clinicaltrials.gov) - P3 | N=1149 | Completed | Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. | Recruiting ➔ Completed

Trial completion • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Efficacy of Hydroxyzine for Patients With Panic Disorder (clinicaltrials.gov) - P4 | N=80 | Not yet recruiting | Sponsor: Sultan Qaboos University

New P4 trial • CNS Disorders • Mood Disorders

Efficacy and Safety of Oxybutynin Versus Paroxetine in Aromatase Inhibitor-induced Vasomotor Symptoms (clinicaltrials.gov) - P3 | N=146 | Recruiting | Sponsor: Cairo University | Not yet recruiting ➔ Recruiting | Initiation date: Dec 2022 ➔ Feb 2022

Enrollment open • Trial initiation date • Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor

Efficacy and Safety of Oxybutynin Versus Paroxetine in Aromatase Inhibitor-induced Vasomotor Symptoms (clinicaltrials.gov) - P3 | N=146 | Not yet recruiting | Sponsor: Cairo University

New P3 trial • Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor

[VIRTUAL] Role of Newer Antidepressants in Social Anxiety Disorder (SAD) (CPNP 2021) - "The 1-year prevalence rate for anxiety disorders is 21.3% in persons aged 18 years and older, and the 1-year prevalence of social anxiety disorder (SAD) specifically is 8.0%.First-line agents for the treatment of SAD include selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitor antidepressants, specifically escitalopram, fluvoxamine controlled-release, paroxetine, sertraline, and venlafaxine extended-release. Only a few studies analyzing the use of newer antidepressants such as vilazodone, levomilnacipran, and vortioxetine have been published...In addition, a literature search on the topic revealed only a few clinical trials evaluating newer antidepressants for the treatment of SAD. Learning Objectives: Evaluate a patient for social anxiety disorder using validated screening tools.Compare the efficacy and/or adverse effects of current treatment options for social anxiety disorder.Assess the role of newer antidepressants in the treatment..."

Cardiovascular • CNS Disorders • Depression • Gastrointestinal Disorder • Major Depressive Disorder • Mental Retardation • Mood Disorders • Psychiatry • Respiratory Diseases • Social Anxiety Disorder • Substance Abuse

The impact of antidepressants on depressive symptom severity, quality of life, morbidity, and mortality in heart failure: a systematic review. (PubMed, Drugs Context) - "Four of the 17 studies addressed QoL as part of their outcomes showing no difference for escitalopram (RCT), significantly greater improvements for paroxetine controlled release (RCT), statistical significance for sertraline compared to control (pilot study), and showing significant improvement before and after treatment (open-label trial) for nefazodone...Although early analyses have pointed to an association of antidepressant use and mortality particularly with fluoxetine, the reviewed studies showed no increase in mortality for antidepressants, and secondary analyses showed improved mortality in patients who achieved remission of depressive symptoms. Out of the various antidepressants studied, which included sertraline, paroxetine, escitalopram, citalopram, bupropion, nefazodone, and nortriptyline, selective serotonin reuptake inhibitors seem to be a safe treatment option for patients with depression and HF. However, due to the variety of study designs as well as the..."

HEOR • Journal • Review • Cardiovascular • CNS Disorders • Congestive Heart Failure • Depression • Heart Failure • Psychiatry

[VIRTUAL] Effect of Adjunctive Brexpiprazole on Sexual Functioning in Mdd According to Concomitant antidepressant: Post Hoc Analysis of Four Short-Term Studies (ASCP 2020) - P3 | "Patients received a prospective ADT with placebo for 8–10 weeks; patients with inadequate response continued on the same ADT and were randomized to 6 weeks of adjunctive brexpiprazole, quetiapine extended-release (XR) (one study, data not shown), or continued placebo...Concomitant ADTs were: escitalopram, fluoxetine, paroxetine controlled-release (CR), sertraline, venlafaxine XR, and duloxetine... In short-term MDD studies, adjunctive brexpiprazole did not adversely affect sexual functioning based on changes in MSFQ scores. ADT selection appeared to have little impact on sexual functioning, although patients receiving paroxetine CR appeared to fare worse than those receiving other concomitant ADTs. Learning Objectives: Based on data from short-term studies of adults with major depressive disorder, discuss the effects of adjunctive brexpiprazole on sexual functioning assessed using changes in Massachusetts General Hospital Sexual Functioning Questionnaire scores."

Retrospective data • CNS Disorders • Depression • Mood Disorders

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Biosimilar

Cardiac autonomic tone, plasma BDNF levels and paroxetine response in newly diagnosed patients of generalised anxiety disorder. (PubMed, Int J Psychiatry Clin Pract) - "Significant differences also noted in square root of mean squared difference of successive NN intervals (RMSSD), (SDNN), pNN50 and in plasma BDNF levels after intervention within GAD group. Significant negative correlation observed between HAM-A scores and SDNN parameter after taking PX CR in GAD. GAD showed cardiac autonomic dysfunction, lowered plasma BDNF levels and their improvement with paroxetine CR.Key messageGAD is associated with significantly lower HRV, suggestive of cardiac autonomic dysfunction and lowered plasma BDNF levels, an indicator of stress.Therapeutic intervention with Paroxetine in GAD patients showed clinically significant improvement reflecting restoration of the cardiac autonomic tone and BDNF levels, thus implying their role as potential biomarkers."

Clinical • Journal • BDNF

Fixed Dose Study of PD 0332334 and Paroxetine for the Treatment of Generalized Anxiety Disorder (clinicaltrials.gov) - P3; N=5; Terminated; Sponsor: Cedars-Sinai Medical Center; N=15 ➔ 5

Clinical • Enrollment change