Publications by authors named "LASSER R"
Article Synopsis
- Zuranolone is a new treatment for postpartum depression approved for a 14-day course and is being studied for how it transfers into breast milk.
- In this study, lactating participants took a daily dose of 30 mg zuranolone, and the transfer was measured, revealing a relative infant dose (RID) of 0.357% after 5 days.
- The findings suggest that the transfer of zuranolone into breast milk is low and stays well below the 10% threshold that is considered safe for breastfeeding.
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.
Article Synopsis
- The MOUNTAIN study aimed to assess the effectiveness and safety of zuranolone, a new treatment for major depressive disorder (MDD), through a phase 3 trial involving adult outpatients.
- 581 participants were randomly assigned to receive either zuranolone (20 mg or 30 mg) or a placebo over 14 days, with improvements in depression symptoms measured primarily by the HDRS-17 scale.
- While the primary endpoint was not met, significant improvements in depressive symptoms were observed at days 3, 8, and 12 for the 30 mg zuranolone group, and the treatment was generally well tolerated with similar rates of side effects as the placebo group.
Article Synopsis
- Zuranolone, a treatment for postpartum depression (PPD), showed significant improvements in both anxiety and insomnia symptoms in women participating in a clinical study compared to a placebo.* -
- The study involved a double-blind, randomized trial with women aged 18-45 who had PPD, following treatment with either zuranolone or a placebo over a 14-day period.* -
- Results indicated higher rates of concurrent remission in depressive and anxiety symptoms with zuranolone, as well as positive effects on insomnia and overall functional health.*
Article Synopsis
- Brexanolone is the first FDA-approved treatment for postpartum depression (PPD), stemming from results of one Phase 2 and two Phase 3 clinical trials.
- In a pooled analysis of these trials, patients receiving brexanolone had faster and more significant reductions in depression, anxiety, and insomnia symptoms than those receiving a placebo.
- The findings reinforce brexanolone's effectiveness in improving PPD symptoms, although the study had limitations in assessing certain outcomes.
Article Synopsis
- Major depressive disorder (MDD) significantly impacts health-related quality of life (HRQoL), and this study examined how the neuroactive steroid zuranolone affects HRQoL using the Short Form-36v2 Health Survey (SF-36v2).
- Adult patients with MDD were randomly assigned to receive either zuranolone or a placebo for two weeks, with HRQoL assessed across various domains at Day 15 showing substantial improvements for those treated with zuranolone, particularly in areas like Mental Health and Vitality.
- The results suggest that zuranolone leads to rapid and meaningful HRQoL enhancements compared to placebo, although the small sample size may limit generalizability and other factors could influence HRQoL
Article Synopsis
- Postpartum depression (PPD) is a prevalent medical issue affecting mothers and their children, leading to the need for effective treatments.* -
- A phase 3 clinical trial tested zuranolone, a new drug, by comparing its effects to a placebo on women with PPD over a 2-week period.* -
- Results showed that zuranolone significantly reduced depression scores compared to placebo, indicating its potential efficacy and safety for treating PPD.*
Article Synopsis
- The study investigates the effectiveness and safety of SAGE-217, a GABA receptor modulator, for treating major depressive disorder compared to a placebo.
- In a double-blind trial, 89 patients received either SAGE-217 or placebo, with the main focus on changes in depression severity after 15 days, measured by the Hamilton Depression Rating Scale (HAM-D).
- Results showed a significant improvement in the SAGE-217 group, with greater reductions in HAM-D scores and no serious side effects reported, though some common mild side effects like headache and dizziness occurred.
Following publication of the original article [1], the author reported errors in the formatting of the table. The details of the errors are as follows.
View Article and Find Full Text PDFBackground: Gantenerumab is a fully human monoclonal antibody that binds aggregated amyloid-β (Aβ) and removes Aβ plaques by Fc receptor-mediated phagocytosis. In the SCarlet RoAD trial, we assessed the efficacy and safety of gantenerumab in prodromal Alzheimer's disease (AD).
Methods: In this randomized, double-blind, placebo-controlled phase III study, we investigated gantenerumab over 2 years.
Evaluate lisdexamfetamine dimesylate (LDX) augmentation of antidepressant monotherapy for executive dysfunction in partially or fully remitted major depressive disorder (MDD). This randomized, placebo-controlled study (NCT00985725) enrolled 143 adults (18-55 years) with mild MDD (Montgomery-Åsberg Depression Rating Scale (MADRS) score ≤ 18) and executive dysfunction (Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Self-Report Global Executive Composite (GEC) T score ≥ 60) on stable antidepressant monotherapy for ≥ 8 weeks. After 2 weeks of screening, participants were randomized to 9 weeks of double-blind LDX (20-70 mg/day) or placebo augmentation, followed by 2 weeks of single-blind placebo.
View Article and Find Full Text PDFObjective: Evaluate the efficacy and safety of lisdexamfetamine dimesylate augmentation for major depressive disorder (MDD) in escitalopram nonremitters.
Method: In this proof-of-concept study (conducted from July 2009-August 2010) with a prespecified critical α = .10, adults with nonpsychotic MDD (DSM-IV-TR criteria) and residual depressive symptoms (17-item Hamilton Depression Rating Scale score ≥ 4) after 8 weeks of open-label escitalopram were randomized to 6 weeks of lisdexamfetamine dimesylate (20-50 mg/d) or placebo augmentation.
Objective: Behavioral rating scales that assess impairments in executive function commonly associated with attention-deficit/hyperactivity disorder (ADHD) may offer advantages over neuropsychological testing. The primary objective of this study was to evaluate the efficacy of lisdexamfetamine dimesylate for executive function deficits in adults with ADHD and clinically significant executive function impairment using self-reported Behavior Rating Inventory of Executive Function-Adult version (BRIEF-A) assessments.
Method: This randomized double-blind study, conducted between May 2010 and November 2010, screened at least 1 participant at 35 of 39 registered US clinical research sites.
Negative symptoms of schizophrenia (NSS), related to hypodopaminergic activity in the mesocortical pathway and prefrontal cortex, are predictive of poor outcomes and have no effective treatment. Use of dopamine-enhancing drugs (eg, psychostimulants) has been limited by potential adverse effects. This multicenter study examined lisdexamfetamine dimesylate (LDX), a d-amphetamine prodrug, as adjunctive therapy to antipsychotics in adults with clinically stable schizophrenia and predominant NSS.
View Article and Find Full Text PDFIntroduction: Lisdexamfetamine dimesylate (LDX) is a long-acting prodrug stimulant for the treatment of attention-deficit/hyperactivity disorder (ADHD). Post hoc subgroup analyses were performed from two studies in children with ADHD to compare the efficacy of LDX in participants who had received prior methylphenidate (MPH) treatment with that of the overall study populations.
Methods: Study 1 (7-week; open-label design) and study 2 (randomized, double-blind, placebo-controlled, crossover, laboratory school design) enrolled children aged 6-12 years with ADHD and baseline ADHD Rating Scale IV (ADHD-RS-IV) total score ≥28.
Objective: The purpose of this article was to describe the relationships between parent-rated executive function (EF) and clinician-rated attention-deficit/hyperactivity disorder (ADHD) symptoms before and after lisdexamfetamine dimesylate (LDX) treatment in children with and without EF deficit.
Methods: In post-hoc analyses of children with ADHD who participated in a 7 week open-label, dose-optimized (LDX 20-70 mg/day) trial, ADHD Rating Scale-IV (ADHD-RS-IV) change scores were compared (using two-sample t tests) between youth with and without clinically significant EF impairment at baseline. Clinically significant impairment was defined as parent-rated Behavior Rating Inventory of EF (BRIEF) Global Executive Composite (GEC) t scores ≥65.
Objective: To describe symptom rebound in children with ADHD treated with lisdexamfetamine dimesylate (LDX) or placebo.
Method: During a 4-week, randomized, double-blind, placebo-controlled trial of LDX, parents/caregivers completed the Conners' Parent Rating Scale-Revised: Short Form symptom rating scale throughout the day. Response, rebound, and emotional lability (EL) were assessed post hoc based on predefined criteria.
Background: Despite the overall high degree of response to pharmacotherapy, consensus is lacking on how to judge clinical response or define optimal treatment/remission when treating adults with attention-deficit/hyperactivity disorder (ADHD). This study examined clinical response and symptomatic remission in analyses of 2 studies of lisdexamfetamine dimesylate (LDX) in adults with ADHD.
Methods: In a 4-week, double-blind, forced-dose trial, adults with ADHD were randomized to LDX 30, 50, and 70 mg/day (mg/d) or placebo.
Objective: To evaluate the efficacy of lisdexamfetamine dimesylate in adults with attention deficit hyperactivity disorder symptom subtypes who exhibit predominantly inattention, hyperactivity/ impulsivity, or combined symptom clusters.
Design/setting/participants: This is a post-hoc analysis from a multicenter, one-year, open-label lisdexamfetamine dimesylate study in adults with attention deficit hyperactivity disorder previously completing two weeks or more in a four-week, randomized, placebo-controlled lisdexamfetamine dimesylate study, using Attention Deficit Hyperactivity Disorder Rating Scale IV symptom ratings as an attention deficit hyperactivity disorder subtype proxy (N=349).
Measurements: Attention Deficit Hyperactivity Disorder Rating Scale IV was measured at baseline of prior study and throughout the open-label study.
Objective: To evaluate the effect of lisdexamfetamine dimesylate (LDX) on emotional lability (EL) in children with ADHD.
Method: Post hoc analyses of a placebo-controlled trial of LDX-stratified children (aged 6-12 years) with ADHD to prominent and not prominent EL at baseline (score >3 or ≤3, respectively, on Conners' Parent Rating Scale [CPRS] items of anger, loss of temper, and irritability). Efficacy was assessed by change in CPRS EL scores and ADHD Rating Scale-IV (ADHD-RS-IV) total and subscale scores.
Comparison of the burden of illness for adults with ADHD across seven countries: a qualitative study.
Health Qual Life Outcomes
May 2012
Background: The purpose of this study was to expand the understanding of the burden of illness experienced by adults with Attention Deficit-Hyperactivity Disorder (ADHD) living in different countries and treated through different health care systems.
Methods: Fourteen focus groups and five telephone interviews were conducted in seven countries in North America and Europe, comprised of adults who had received a diagnosis of ADHD. The countries included Canada, France, Germany, Italy, The Netherlands, United Kingdom, and United States (two focus groups in each country).