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AbstractObjectiveMethodsResultsConclusion\nPlain Language SummaryLittle is known about the healthcare resource utilization (HRU) associated with different adjunctive atypical antipsychotics (AAs) for the treatment of major depressive disorder (MDD). This analysis evaluated HRU in patients with MDD treated adjunctively with cariprazine versus other AAs.Merative MarketScan databases were searched for claims made from 01/01/2018 to 12/31/2020 (Medicaid) or 3/31/2021 (commercial and Medicare). The study included adults with ≥1 inpatient MDD claim or ≥2 outpatient MDD claims >30 days apart and ≥1 claim for cariprazine, brexpiprazole, generic aripiprazole, or generic quetiapine adjunctive to an antidepressant (ie, ≥14-day overlap between AA and antidepressant). Outcomes included all-cause and MDD-related inpatient stays and emergency department (ED), office, and psychiatric visits. Results were reported as estimated mean ratios, calculated via negative binomial regression, of the comparator AA to cariprazine with 95% CIs.Analyses included 40,195 patients (cariprazine [n = 1,038], brexpiprazole [n = 3,221], generic aripiprazole [n = 20,601], generic quetiapine [n = 15,335]). The cariprazine cohort had significantly fewer all-cause and MDD-related inpatient stays relative to all other AA cohorts. All-cause ED visits were significantly lower in the cariprazine versus generic quetiapine cohort, and MDD-related ED visits were significantly lower in the cariprazine versus generic aripiprazole and generic quetiapine cohorts. ED visits were similar between cariprazine and all other cohorts. All-cause and MDD-related office and psychiatric visits were significantly lower in the cariprazine versus most other AA cohorts.Although causality cannot be determined from these real-world findings, results suggest that in patients with MDD, initiating adjunctive cariprazine is associated with significantly lower HRU for certain outcomes relative to other AAs.Patients with major depressive disorder (MDD) often use healthcare resources, such as going to the doctor. Cariprazine is an atypical antipsychotic that can be used with antidepressants to treat MDD. This study looked at the different amounts of healthcare resources patients used based on which medication they took with their antidepressant.Insurance databases were used to find adults with MDD prescribed atypical antipsychotics with antidepressants. We then compared the number of times patients went to the hospital, emergency department, or doctor’s office based on if they started cariprazine, brexpiprazole, generic aripiprazole, or generic quetiapine. Patients who started cariprazine went to the hospital less than those who started other drugs. Patients who started cariprazine also went to the emergency department for any reason less than those who started generic quetiapine. Also, patients who started cariprazine went to the emergency department for MDD reasons less than patients who started generic aripiprazole or quetiapine. Last, patients who started cariprazine went to the doctor’s office less than those who started most of the other drugs. Our results suggest that treatment of MDD with an antidepressant and cariprazine is associated with less use of healthcare resources than treatment with other atypical antipsychotics. [ABSTRACT FROM AUTHOR]

Background: Although most survivors of breast cancer report substantial sexual concerns following treatment, few receive support for these concerns. Delivering sexual health care to survivors of breast cancer via the internet could overcome many of the barriers to in-person treatment. Even when delivered remotely, survivor time constraints remain a leading barrier to sexual health intervention uptake. Objective: Guided by the multiphase optimization strategy methodological framework, the primary objective of this study is to identify the most efficient internet-delivered sexual health intervention package that is expected to provide survivors of breast cancer the greatest benefit with the fewest (and least-intensive) intervention components. This study aims to determine how intervention components work (mediators) and for whom they work best (moderators). Methods: Partnered, posttreatment adult female survivors of breast cancer (N=320) experiencing at least 1 bothersome sexual symptom (ie, pain with sex, vaginal dryness, low sexual desire, and difficulty with orgasm) related to their breast cancer treatment will be enrolled. Clinic-based recruitment will be conducted via the Wake Forest National Cancer Institute Community Oncology Research Program (NCORP) Research Base. Participants will be randomly assigned to 1 of 16 combinations of four intervention components with two levels each in this factorial trial: (1) psychoeducation about cancer-related sexual morbidity (receive either enhanced vs standard versions); (2) communication skills training for discussing concerns with health care providers (received vs not received); (3) communication skills training for discussing concerns with a partner (received vs not received); and (4) intimacy promotion skills training (received vs not received). Cores will be fully automated and implemented using a robust internet intervention platform with highly engaging elements such as animation, video, and automated email prompts. Survivors will complete web-based assessments at baseline (prerandomization time point) and again at 12 and 24 weeks later. The primary study aim will be achieved through a decision-making process based on systematically evaluating the main and interaction effects of components on sexual distress (Female Sexual Distress Scale–Desire, Arousal, Orgasm) and sexual functioning (Female Sexual Function Index) using a generalized linear model approach to ANOVA with effect coding. Mediation analyses will be conducted through a structural equation modeling approach, and moderation analyses will be conducted by extending the generalized linear model to include interaction effects. Results: This protocol has been reviewed and approved by the National Cancer Institute Central Institutional Review Board. Data collection is planned to begin in March 2024 and conclude in 2027. Conclusions: By identifying the combination of the fewest and least-intensive intervention components likely to provide survivors of breast cancer the greatest sexual health benefit, this study will result in the first internet intervention that is optimized for maximum impact on the undertreated, prevalent, and distressing problem of breast cancer–related sexual morbidity. Trial Registration: ClinicalTrials.gov NCT06216574; https://clinicaltrials.gov/study/NCT06216574 International Registered Report Identifier (IRRID): PRR1-10.2196/57781 [ABSTRACT FROM AUTHOR]

This study assessed the efficacy and safety of a 14-day treatment course of once-daily zuranolone 50 mg, an investigational oral positive allosteric modulator of the γ-aminobutyric acid type A (GABAA) receptor, for the treatment of major depressive disorder. Patients 18–64 years of age with severe major depressive disorder were enrolled in this randomized, double-blind, placebo-controlled trial. Patients self-administered zuranolone 50 mg or placebo once daily for 14 days. The primary endpoint was change from baseline in total score on the 17-item Hamilton Depression Rating Scale (HAM-D) at day 15. Safety and tolerability were assessed by incidence of adverse events. Of 543 randomized patients, 534 (266 in the zuranolone group, 268 in the placebo group) constituted the full analysis set. Compared with patients in the placebo group, patients in the zuranolone group demonstrated a statistically significant improvement in depressive symptoms at day 15 (least squares mean change from baseline HAM-D score, −14.1 vs. −12.3). Numerically greater improvements in depressive symptoms for zuranolone versus placebo were observed by day 3 (least squares mean change from baseline HAM-D score, −9.8 vs. −6.8), which were sustained at all visits throughout the treatment and follow-up periods of the study (through day 42, with the difference remaining nominally significant through day 12). Two patients in each group experienced a serious adverse event; nine patients in the zuranolone group and four in the placebo group discontinued treatment due to adverse events. Zuranolone at 50 mg/day elicited a significantly greater improvement in depressive symptoms at day 15, with a rapid time to effect (day 3). Zuranolone was generally well tolerated, with no new safety findings compared with previously studied lower dosages. These findings support the potential of zuranolone in treating adults with major depressive disorder. [ABSTRACT FROM AUTHOR]