A5014589662- Treatment of Major Depression
- Mental Health Research Topics
- Schizophrenia research and treatment
- Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Health Systems, Economic Evaluations, Quality of Life
- Dementia and Cognitive Impairment Research
- Blood Pressure and Hypertension Studies
- Cerebrovascular and Carotid Artery Diseases
- Functional Brain Connectivity Studies
- Healthcare Decision-Making and Restraints
- Psychiatric care and mental health services
- Bipolar Disorder and Treatment
- Advanced Causal Inference Techniques
- Pain Management and Placebo Effect
- Statistical Methods and Inference
- Statistical Methods and Bayesian Inference
- Cardiac Health and Mental Health
- Acute Ischemic Stroke Management
- Bayesian Methods and Mixture Models
- Consumer Attitudes and Food Labeling
- Child Nutrition and Feeding Issues
- Statistical Methods in Clinical Trials
- Medication Adherence and Compliance
- Nutritional Studies and Diet
- Neuroendocrine regulation and behavior
Lundbeck (Denmark)
2013-2025
Hvidovre Hospital
2024
University of Pennsylvania
2020
University of Toronto
2012
Agitation is a prevalent, distressing, and burdensome manifestation of Alzheimer dementia in need an efficacious, safe, well-tolerated treatment.
Introduction: The effective management of irritability is a key need in young people with autism spectrum disorder (ASD). We evaluated the efficacy and safety brexpiprazole children adolescents associated ASD. Methods: This was an 8-week, phase 3, randomized, double-blind, placebo-controlled trial (NCT04174365) 26-week, open-label extension (OLE, NCT04258839) (0.25-3 mg/day based on body weight) (5-17 years) diagnosis ASD, score ≥18 Aberrant Behavior Checklist-Irritability (ABC-I) subscale,...
Cognitive dysfunction is common in depression during both acute episodes and remission. Vortioxetine a novel multimodal antidepressant that has improved cognitive function including executive depressed patients randomised placebo-controlled clinical trials. However, it unclear whether vortioxetine able to target directly the neural circuitry implicated deficits depression. Remitted (n=48) healthy volunteers were receive 14 days treatment with 20 mg or placebo double-blind design. The effects...
Background There is controversy about the implications of relatively small average drug–placebo differences observed in randomised controlled trials antidepressant medications. Aims To investigate whether efficacy better understood as a large effect subgroup patients. Method The mixture model was used to identify patient subgroups (patients benefiting or not from treatment) directly skewness Montgomery–åsberg Depression Rating Scale (MADRS) scores at week 8. Results MADRS improved by 15.9...
Introduction The Cohen-Mansfield Agitation Inventory (CMAI) quantifies the frequency of agitation behaviors in elderly persons. This post hoc analysis data from brexpiprazole clinical program aimed to determine a meaningful within-patient change (MWPC) threshold for CMAI Total score among patients with associated dementia due Alzheimer’s disease. Methods Data were included three 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-arm trials treatment disease (...
Background Recurrent stroke accounts for about 25% of admissions acute stroke. For the prevention recurrent cerebro and cardiovascular disease, patients are advised to change modifiable risk factors before discharge from units. Aims To investigate in 1 year after explore feasibility a preventive programme aimed at discharged hospital. Methods From April 2004 February 2005, 173 admitted hospital with diagnosis were consecutively included interviewed their medical history One-year follow-up...
To investigate the temporal interrelationship between depression severity, cognitive symptoms, and functioning in patients with major depressive disorder (MDD) PERFORM study (NCT01427439).PERFORM was a 2-year, multicenter, prospective, noninterventional cohort outpatients MDD who were either initiating antidepressant monotherapy or undergoing their first switch of antidepressant. Patients enrolled by general practitioner psychiatrist. Structural equation model (SEM) analysis used to explore...
New pharmacotherapy options are needed for posttraumatic stress disorder (PTSD). To investigate the efficacy, safety, and tolerability of brexpiprazole sertraline combination treatment (brexpiprazole + sertraline) compared with placebo PTSD. This was a parallel-design, double-blind, randomized clinical trial conducted from October 2019 to August 2023. The study had 1-week, run-in period followed by an 11-week, randomized, active-controlled, parallel-arm (with 21-day follow-up) took place at...
Patient-reported outcomes can measure domains that are personally meaningful, such as life engagement, which reflects motivation, pleasure, and well-being. This study explored whether certain items from the Inventory of Depressive Symptomatology Self-Report (IDS-SR) capture patient engagement in major depressive disorder (MDD).IDS-SR were identified by a) a panel expert psychiatrists (n = 4), b) interviews 20), c) principal component analysis (PCA) to explore clustering items. Psychometric...
. The prevalence of patients with prior stroke is increasing globally. Accordingly, there a need for up-to-date evidence patient-related prognostic factors recurrence, post myocardial infarction (MI) and death based on long-term follow-up survivors. For this purpose, the RIALTO study was established in 2004.
Patient-reported outcomes can capture domains that are meaningful to patients, such as life engagement in major depressive disorder (MDD), which reflects fulfillment, well-being, and participation valued activities. This analysis investigated the effects of brexpiprazole adjunct antidepressant treatment (ADT) on patient over short long term, using 10-item Inventory Depressive Symptomatology Self-Report (IDS-SR10) Life Engagement subscale. Short-term data were pooled from three 6-week,...
The aim of this proof-of-concept study was to compare the efficacy escitalopram (20 mg/d) in combination with fixed doses gaboxadol mg) treatment patients severe major depressive disorder (MDD). Adult were randomized 8 wk double-blind placebo (n=71), mg, n=140), mg)+gaboxadol (5 (n=139), or (10 (n=140). pre-defined primary analysis an covariance (ANCOVA) change from baseline endpoint (week 8) Montgomery–Åsberg Depression Rating Scale (MADRS) total score using last observation carried forward...
The draft ICH E9 (R1) addendum by the International Conference on Harmonisation working group opens for use of a principal stratum (PS) in analysis study data regulatory purpose, if relevant estimand can be justified. Inspired so-called complier average causal effect and work within this framework, we propose new estimator—Extrapolation based propensity to comply—that estimates treatment an active A relative comparator B (active or placebo), PS patients who would comply, they were treated...
The use of electronic-based devices to measure and improve adherence subjects in clinical trials is increasing. AiCure has developed a mobile technology that claimed provide visual confirmation drug ingestion. While there evidence suggesting including such self-monitoring device study increases adherence, the quality data produced by may be questionable. Can reliably distinguish whether subject takes or not?Adherence was calculated based on exposure, self-reporting for randomized an...
Abstract Background In schizophrenia, a patient’s quality of life and level psychosocial functioning is dependent on two key domains: the severity their psychotic symptoms, side effects antipsychotic medication. addition, people with schizophrenia experience motivation deficits, thus patient engagement component successful treatment outcomes. The present analyses investigated effect brexpiprazole (a serotonin–dopamine activity modulator that partial agonist at 5-HT1A dopamine D2 receptors,...