Category Ranking
98%
Total Visits
921
Avg Visit Duration
2 minutes
Citations
20
Article Abstract
Objectives: To characterize the effects of adjunctive brexpiprazole on patient life engagement and depressive symptoms in patients with major depressive disorder (MDD) using patient-reported outcomes.
Methods: An 8-week, Phase 4, open-label, interventional study was conducted at 15 Canadian trial sites between April 2021 and May 2022. Adult outpatients with MDD (at least moderately severe) and inadequate response to 1-2 antidepressants continued their current antidepressant and received oral adjunctive brexpiprazole 0.5-2 mg/day. Co-primary endpoints were change from baseline to Week 8 in Inventory of Depressive Symptomatology Self-Report (IDS-SR) 10-item Life Engagement subscale score, and IDS-SR 30-item total score. Safety was assessed by standard variables.
Results: Of 122 enrolled patients, 120 (98.4%) were treated (mean [] dose: 1.2 [0.4] mg/day) and analyzed, and 111 (91.0%) completed the study. Statistically significant least squares mean improvements to Week 8 were observed on IDS-SR Life Engagement subscale score (baseline mean []: 16.1 [4.7]; change [95% confidence interval]: -8.11 [-9.34, -6.88]; < 0.001) and IDS-SR total score (baseline mean []: 41.3 [9.8]; change [95% confidence interval]: -17.38 [-20.08, -14.68]; < 0.001). Improvements were observed from Week 2, onwards. Treatment-emergent adverse events with incidence ≥5% were fatigue ( = 13, 10.8%), headache ( = 13, 10.8%), insomnia ( = 12, 10.0%), nausea ( = 9, 7.5%), tremor ( = 8, 6.7%), and weight increase ( = 7, 5.8%). Six patients (5.0%) discontinued due to adverse events. Mean () change in body weight from baseline to last visit was +1.9 (3.4) kg.
Conclusions: Using an exploratory patient-reported outcome measure, patients with MDD and inadequate response to antidepressants who received open-label adjunctive brexpiprazole showed early and clinically meaningful improvement in patient life engagement, which should be further assessed in a prospective randomized controlled trial. Patient-rated depressive symptoms (on the validated 30-item IDS-SR) also improved. Adjunctive brexpiprazole was well tolerated, and no new safety signals were observed.
Clinical Trial Registration: ClinicalTrials.gov identifier: NCT04830215.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11168343 | PMC |
| http://dx.doi.org/10.1177/07067437241233965 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Implementation and evaluation of a family planning intervention engaging mothers-in-law of young women in India: a mixed methods pilot study.
Glob Health Action
December 2025
Institute for Global Health Sciences, University of California, San Francisco, CA, USA.
Background: Despite evidence that mothers-in-law (MILs) influence daughters-in-law's (DILs) fertility and family planning decisions in South Asia, emphasizing early fertility and male grandchildren, few reproductive health interventions engage MILs directly.
Objectives: We assessed the feasibility, acceptability, and qualitative impact of a reproductive health and life skill-based intervention on MILs in tribal Rajasthan, India, using a mixed-methods, single-group cluster pilot study.
Methods: We tested a light-touch four-session intervention delivered over 4 months to MILs of newly married women that covered MILs' health, conception, and communication with DILs and sons and addressed modern healthcare misconceptions, while challenging son preference and fertility norms.
Addressing Rehabilitation Needs in Pediatric Palliative Care: The Role of Occupational Therapy.
Phys Occup Ther Pediatr
September 2025
Department of Pediatric Palliative Care, Ankara City Hospital, Ankara, Turkey.
Aims: Children with life-limiting illnesses face physical, cognitive, and emotional challenges that restrict their activities of daily living. Although these needs require a holistic approach, rehabilitation services, particularly occupational therapy, are often limited in pediatric palliative care. This study aimed to evaluate the unmet rehabilitation needs of children receiving pediatric palliative care in Turkey based on the Person-Environment-Occupation model.
View Article and Find Full Text PDF"You Want to Eat Healthy, Especially When You're Pregnant. But Sometimes, It's Just Not Possible": Perceptions of Facilitators and Barriers to Healthy Food and Diet Practices During Pre-Conception and Pregnancy.
J Hum Nutr Diet
October 2025
School of Health, Medicine and Life Sciences, University of Hertfordshire, Hatfield, UK.
Background: Evidence suggests that women should eat a healthy diet during pre-conception and pregnancy as this benefits their own health as well as reducing the risk of non-communicable diseases in offspring (such as obesity, diabetes, hypertension, cardiovascular and mental health problems); however, previous work indicates that the recommendations are not being followed. This study aimed to understand: the facilitators and barriers to healthy food and diet practices during pre-conception and pregnancy; how these barriers could be addressed, and the changes required to facilitate good food practices.
Methods: The research used a qualitative approach; five online focus groups were undertaken with 19 women living across the UK who were trying to conceive, pregnant or had babies under 6-months old.
Training and Practice Gaps in Nursing Home Palliative Care: A Cross-Sectional Study.
J Am Geriatr Soc
September 2025
Division of Geriatrics and Palliative Medicine, Department of Medicine, Weill Cornell Medicine, New York, New York, USA.
Background: Palliative care needs are prevalent among nursing home (NH) residents. However, access to and integration of palliative care services remain limited. NHs often rely on a workforce with varying levels of training and exposure to palliative care, which may influence care quality and consistency.
View Article and Find Full Text PDFMolecular characterization of endosomal self RNA Rmrp-engaged TLR3 dimerization to prime innate activation.
Cell Res
September 2025
Department of Immunology, Center for Immunotherapy, Institute of Basic Medical Sciences, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.
The pre-dimerization of endosome-localized RNA sensor Toll-like receptor 3 (TLR3) is required for its innate recognition, yet how TLR3 pre-dimers are formed and precisely primed for innate activation remains unclear. Here, we demonstrate that endosome-localized self RNA Rmrp directly binds to TLR3 and induces TLR3 dimerization in the early endosome but does not interact with endosome-localized TLR7, TLR8, TLR9 or cytoplasmic RNA sensor RIG-I under homeostatic conditions. Cryo-EM structure of Rmrp-TLR3 complex reveals a novel lapped conformation of TLR3 dimer engaged by Rmrp, which is distinct from the activation mechanism by dsRNA and the specific structural feature at the 3'-end of Rmrp is critical for its functional interaction with TLR3.
View Article and Find Full Text PDF