Unpublished trials of alprazolam XR and their influence on its apparent efficacy for panic disorder.

OBJECTIVE: To test for publication bias with alprazolam, the most widely prescribed benzodiazepine, by comparing its efficacy for panic disorder using trial results from (1) the published literature and (2) the US Food and Drug Administration (FDA). METHODS: From FDA reviews, we included data from all phase 2/3 efficacy trials of alprazolam extended-release (Xanax XR) for the treatment of panic disorder. A search for matching publications was performed using PubMed and Google Scholar. Publication bias was examined by comparing: (1) overall trial results (positive or not) according to the FDA v. corresponding publications; (2) effect size (Hedges's g) based on FDA data v. published data. RESULTS: The FDA review showed that five trials were conducted, only one of which (20%) was positive. Of the four not-positive trials, two were published conveying a positive outcome; the other two were not published. Thus, according to the published literature, three trials were conducted and all (100%) were positive. Alprazolam's effect size calculated using FDA data was 0.33 (CI95% 0.07-0.60) v. 0.47 (CI95% 0.30-0.65) using published data, an increase of 0.14, or 42%. CONCLUSIONS: Publication bias substantially inflates the apparent efficacy of alprazolam XR.

Mental Health-Related Outpatient Visits Among Adolescents and Young Adults, 2006-2019.

Importance: Concerns over the mental health of young people have been increasing over the past decade, especially with the rise in mental health burden seen during the COVID-19 pandemic. Examining trends in mental health-related outpatient visits provides critical information to elucidate contributing factors, identify vulnerable populations, and inform strategies to address the mental health crisis. Objective: To examine characteristics and trends in mental health-related outpatient visits and psychotropic medication use among US adolescents and young adults. Design, Setting, and Participants: A retrospective cross-sectional analysis of nationally representative data from the National Ambulatory Medical Care Survey, an annual probability sample survey, was conducted from January 2006 to December 2019. Participants included adolescents (age 12-17 years) and young adults (age 18-24 years) with office-based outpatient visits in the US. Data were analyzed from March 1, 2023, to September 15, 2023. Main Outcomes and Measures: Mental health-related outpatient visits were identified based on established sets of diagnostic codes for psychiatric disorders. Temporal trends in the annual proportion of mental health-related outpatient visits were assessed, including visits associated with use of psychotropic medications. Analyses were stratified by age and sex. Results: From 2006 to 2019, there were an estimated 1.1 billion outpatient visits by adolescents and young adults, of which 145.0 million (13.1%) were associated with a mental health condition (mean [SD] age, 18.4 [3.5] years; 74.0 million females [51.0%]). Mental health-related diagnoses were more prevalent among visits by male (16.8%) compared with female (10.9%) patients (P < .001). This difference was most pronounced among young adults, with 20.1% of visits associated with a psychiatric diagnosis among males vs 10.1% among females (P < .001). The proportion of mental health-related visits nearly doubled, from 8.9% in 2006 to 16.9% in 2019 (P < .001). Among all outpatient visits, 17.2% were associated with the prescription of at least 1 psychotropic medication, with significant increases from 12.8% to 22.4% by 2019 (P < .001). Conclusions and Relevance: In this cross-sectional study, there were substantial increases in mental health-related outpatient visits and use of psychotropic medications, with greater overall burden among male patients. These findings provide a baseline for understanding post-pandemic shifts and suggest that current treatment and prevention strategies will need to address preexisting psychiatric needs in addition to the effects of the COVID-19 pandemic.

Ethnoracial disparities in care on a consultation-liaison service at an academic hospital.

BACKGROUND: There is currently an increasing recognition of and focus on structural and institutional racism and its impacts on health disparities. In psychiatry and mental health, research has focused on racial and ethnic disparities in the availability and utilization of mental health services, care in emergency departments, and inpatient psychiatric services. Little is known about disparities in care on general hospital psychiatry consultation-liaison (CL) services. METHODS: In this exploratory study, we conducted a retrospective chart review using electronic health record (EHR) data of all adults (≥ 18 years of age) admitted to inpatient medical or surgical floors at an urban academic medical center for whom a psychiatric consultation was requested during the study period. We examined differences by race and ethnicity in: rates of consultation requests; use of legal holds, constant observation, restraints; follow-up by the CL service; and ultimate disposition. RESULTS: The service received 310 unique consults during the study period. Compared to hospital-wide numbers, Black-identifying patients were over-represented in our sample (11.9% vs 6.6%), while Latinx patients were underrepresented (6.1% vs 9.8%). Of the clinical and outcome variables collected, there were higher odds of being placed on a legal hold both prior to (OR 2.6) and after the consult question (OR 2.98) and in the odds of having a one-to-one observer prior to (OR 2.47) and after (OR 2.9) the initial consult visit for Black-identifying patients, when adjusting for confounders. There were no other measurable differences in care or outcomes by racial or ethnic categories. CONCLUSION: Black-identifying patients may be more likely to receive psychiatric consultation and be placed on legal holds because of a combination of chronic adverse social determinants of health and race-based bias. Conversely, Latinx patients may be less likely to receive psychiatric consultation because of language barriers among other factors. The lack of disparities identified in other domains may be encouraging, but larger studies are needed. Further research is also needed to identify causality and interventions that could help close the gap in care and outcomes for racial and ethnic minorities.