Publications by authors named "Fiona Forrestal"
Long-Term Safety and Efficacy of Initial and Repeat Treatment Courses With Zuranolone in Adult Patients With Major Depressive Disorder: Interim Results From the Open-Label, Phase 3 SHORELINE Study.
J Clin Psychiatry
December 2023
Article Synopsis
- Zuranolone is a new oral treatment for postpartum depression and is being studied for major depressive disorder, acting as a modulator of GABA receptors in the brain.
- The ongoing SHORELINE Study aims to assess the long-term safety and effectiveness of zuranolone in adults with major depressive disorder, with patients undergoing treatment for up to 1 year.
- Preliminary results show that a significant percentage of patients experienced mild to moderate side effects, but there were notable improvements in depression scores after initial and repeat treatments.
Article Synopsis
- - Major depressive disorder (MDD) can significantly impact a person's ability to function and traditional antidepressant treatments take weeks to show effects; zuranolone is a new oral treatment that's been approved for postpartum depression and is being studied for MDD.
- - The CORAL Study tested the effectiveness of zuranolone (50 mg) when combined with standard antidepressant therapy against a placebo in 425 adults with MDD, focusing on improvements in depression symptoms within the first three days.
- - Results showed that patients taking zuranolone experienced a greater reduction in depression scores by Day 3 compared to those on placebo, with mild to moderate side effects being the most common, such as drowsiness and headaches.
Article Synopsis
- Postpartum depression (PPD) is a common issue affecting new mothers, and this study explored the effectiveness and safety of zuranolone as a treatment option over a 14-day period.
- In a phase 3 trial with 196 participants, those taking zuranolone showed significant improvements in depression scores compared to those on a placebo, with benefits noted as early as day 3.
- The treatment was well tolerated, with some side effects like somnolence and dizziness, but no serious risks such as loss of consciousness or increased suicidal thoughts were reported.
Article Synopsis
- * Patients in the zuranolone group experienced notable symptom relief as early as day 3, and this improvement was sustained through day 15 and beyond, with a statistically significant change from baseline scores.
- * The treatment was generally well tolerated, with similar rates of serious adverse events in both the zuranolone and placebo groups, suggesting its potential as a viable option for treating major depressive disorder.
Importance: The EMERGE and ENGAGE phase 3 randomized clinical trials of aducanumab provide a robust data set to characterize amyloid-related imaging abnormalities (ARIA) that occur with treatment with aducanumab, an amyloid-β (Aβ)-targeting monoclonal antibody, in patients with mild cognitive impairment due to Alzheimer disease or mild Alzheimer disease dementia.
Objective: To describe the radiographic and clinical characteristics of ARIA that occurred in EMERGE and ENGAGE.
Design, Setting, And Participants: Secondary analysis of data from the EMERGE and ENGAGE trials, which were 2 double-blind, placebo-controlled, parallel-group, phase 3 randomized clinical trials that compared low-dose and high-dose aducanumab treatment with placebo among participants at 348 sites across 20 countries.
Introduction: Alzheimer's disease (AD) is a chronic and progressive neurodegenerative disease that places a substantial burden on patients and caregivers. Aducanumab is the first AD therapy approved by the US Food and Drug Administration to reduce a defining pathophysiological feature of the disease, brain amyloid plaques. In the phase 3 clinical trial EMERGE (NCT02484547), aducanumab reduced clinical decline in patients with mild cognitive impairment (MCI) due to AD and mild AD dementia and confirmed amyloid pathology.
View Article and Find Full Text PDFBackground: Vixotrigine is a voltage and use dependent sodium channel blocker currently under development for treatment of various neuropathic pain indications.
Objective: The objective of this work was to develop a population pharmacokinetic model and assess effects of various covariates on pharmacokinetic parameters of vixotrigine.
Method: Plasma concentration-time data from 12 Phase 1 or 2 studies were included in the analyses.
Background: Although several disease-modifying treatments are available for relapsing multiple sclerosis, treatment effects have been more modest in progressive multiple sclerosis and have been observed particularly in actively relapsing subgroups or those with lesion activity on imaging. We sought to assess whether natalizumab slows disease progression in secondary progressive multiple sclerosis, independent of relapses.
Methods: ASCEND was a phase 3, randomised, double-blind, placebo-controlled trial (part 1) with an optional 2 year open-label extension (part 2).
Objectives: Report long-term safety and effectiveness of natalizumab over 240 weeks in the prospective, observational, open-label Safety of TYSABRI Re-dosing and Treatment (STRATA) Study.
Methods: Patients (N = 1,094) previously enrolled in natalizumab multiple sclerosis clinical trials received natalizumab 300 mg IV every 4 weeks, up to 240 weeks. Serious adverse events, Expanded Disability Status Scale (EDSS) scores, and annualized relapse rates were analyzed.
Natalizumab is an immunomodulatory drug approved for the treatment of multiple sclerosis. This randomized, multicenter, open-label study evaluated natalizumab's effects on immunization responses to a recall antigen (tetanus toxoid [TT]) and a neoantigen (keyhole limpet hemocyanin [KLH]) in patients with relapsing forms of multiple sclerosis (MS). Natalizumab-naive relapsing MS patients were randomized (1:1; n=30 per group) to receive TT and KLH immunizations either without natalizumab treatment (control) or after 6 months of natalizumab treatment (natalizumab group).
View Article and Find Full Text PDFObjective: Analyses were conducted to determine the clinical utility of measuring JC virus (JCV) DNA in blood or urine of natalizumab-treated multiple sclerosis (MS) patients to predict the risk of progressive multifocal leukoencephalopathy (PML).
Methods: A total of 12,850 blood and urine samples from nearly 1,400 patients participating in natalizumab clinical trials were tested for JCV DNA using a commercially available quantitative polymerase chain reaction (qPCR) assay. A subset of these samples was also tested using a more sensitive qPCR assay developed at the National Institutes of Health (NIH).