Gabrielle Ientile, Assistant Editor

Results of a recent study published in the 

 showed that an alarming number of young adult respondents reported significant loneliness, depressive symptoms, and moderate-to-severe anxiety during the coronavirus disease 2019 (COVID-19) pandemic.

Researchers used a national survey to evaluate the effect the coronavirus disease 2019 (COVID-19) pandemic is having on young adults. In light of coinciding loneliness and addiction epidemics in the United States, the survey has revealed concerning trends in this demographic related to mental health and substance use amid the pandemic.

“Even before imposed COVID-19 social restrictions, loneliness had been gaining attention as a public health crisis,” the researchers wrote in the study. However, few studies have focused on documenting and understanding loneliness and issues related to mental health wellbeing in young adults.

Investigators employed a web-based survey, approved by the University of Miami Institutional Review Board, that recruited participants on social media and networking sites—Instagram, Facebook, LinkedIn, and Twitter—via an anonymous link to the Qualtrics 2020 survey. Respondents also gained access through US college and university newsletters and student association Facebook pages.

Between April 22 and May 11, 2020, 1008 respondents 18 to 35 years of age completed the survey, which evaluated mental health through various mechanisms. Investigators determined loneliness through the UCLA Loneliness Scale; substance use behaviors through the WHO’s Alcohol Use Disorder Identification Test (AUDIT) and the Drug Abuse Screening Test (DAST-10); and anxiety and depression through the Generalized Anxiety Disorder (GAD-7) Questionnaire and the Center for Epidemiologic Studies Depression scale (CES-D-10).

Demographic analysis showed a median age of 28 years, with 86% of respondents older than 23 years. Ninety-one percent were not enrolled in school, with 63% living with 2 or 3 people at the time of the survey. The majority of respondents reported their race as white (76%); 10% were Black, and 24% were Hispanic.

The mean score on the UCLA Loneliness Scale was 49.54. Forty-nine percent of participants reported scores above 50 in the 20-80 scale. AUDIT ranks respondents according to a 0-40 scale, where a score higher than 15 is likely to indicate high-risk drinking and alcohol dependence. Thirty percent of respondents reported a score above 16 and 19% reported binge drinking at least weekly.

Of the 22% of young adults included in the study who reported using drugs, 38% showed scores indicating substantial or severe drug use. Sixty-two percent of respondents ranked as showing either moderate (45%) or severe (19%) anxiety. Seventy-nine percent indicated the presence of significant depressive symptoms, according to the CES-D analysis.

Analyses showed that most participants who reported an increase in feeling lonely also reported more alcohol use (58%), drug use (56%), anxiety (76%), and depression (78%).

“These results reveal heightened levels compared to previously documented prevalence of loneliness, anxiety, and depression,” the study authors wrote.

Findings reiterate the demand for attention to the loneliness epidemic in the US and underscore the importance of prevention and intervention on young adults,” investigators added.

1. Horigian VE, Schmidt RD, Feaster DJ. Loneliness, mental health, and substance use among US young adults during COVID-19. 

https://doi.org/10.1080/02791072.2020.1836435

Articles

A recent study showed “alarming” rates of reported loneliness, anxiety, depression, and substance use in young adults during COVID-19. 

Mental Health Conditions, Substance Use Heightened in Young Adults Amid COVID-19 Pandemic

Impel NeuroPharma recently announced its submission of a New Drug Application (NDA) to the FDA for dihydroergotamine mesylate, or DHE, (INP104) for the acute treatment of migraine headaches in adults with or without aura.

DHE utilizes NeuroPharma’s proprietary and novel delivery system called Precision Olfactory Delivery (POD) technology. It is designed to target the vascular rich upper nasal space in order to maximize consistent absorption of DHE.

Migraine is a common and often debilitating severe head pain affecting an estimated 39 million individuals in the United States; however, the disease is underdiagnosed, and of the 19 million patients with diagnosed migraine, only 4 million have been prescribed medication. The neurological disease is associated with symptoms such as nausea, vomiting, and sensitivity to light and sound.

DHE is designed to deliver a lower dose of the drug compared with FDA-approved and investigational products, according to the news release.

The NDA is based on the phase 3, multicenter STOP 301 study. The study included 360 patients at 36 trial sites in the US. Patients were included based on their documented diagnosis of migraine with or without aura who experienced a minimum of 2 attacks each month for the last 6 months at the time of the study. Investigators evaluated patients either under a 24-week or 52-week study period.

Study investigators treated over 5650 migraine attacks during the study and met the primary objectives, with no new safety signals reported. The most frequently reported treatment-emergent adverse events (TEAEs) were mild and brief and included nasal congestion (16.7%), nausea (7.9%), nasal discomfort (5.4%), and abnormal taste (5.1%).

Overall, 66.3% of patients reported pain relief, 38% reported pain freedom, and 52% reported freedom from their most bothersome migraine symptom (MBS) within 2 hours of the first dose of DHE. A total of 16.3% of patients experienced relief from their migraine in as early as 15 minutes, with improvements over time.

The STOP 301 study is among the largest longitudinal studies of DHE, according to the news release. 

Impel Neuropharma Announces FDA Submission of New Drug Application For INP104 For the Acute Treatment of Migraine. News Release. Impel Neuropharma; October 26, 2020. Accessed November 17, 2020. 

https://impelnp.com/2020/11/09/impel-neuropharma-announces-fda-submission-of-new-drug-application-for-inp104-for-the-acute-treatment-of-migraine/

The pharmaceutical company has submitted a New Drug Application for dihydroergotamine mesylate for fast and lasting whole migraine relief in adults with and without aura. 

Impel NeuroPharma Announces NDA Submission for Acute Migraine Treatment

Results of an ongoing study has demonstrated an association in coronavirus disease 2019 (COVID-19) patients between the presence of hypertension and diabetes and a higher risk of neurological complications.

The study, which will be presented at the Radiological Society of North America (RSNA) annual meeting held virtually this year, reported that neurological complications can be fatal when it comes to COVID-19 infection and that these manifestations are more common in patients with hypertension and type 2 diabetes mellitus, according to Colbey W. Freeman, MD, chief resident in the department of Radiology at Penn Medicine in Philadelphia, Pennsylvania.

“These populations may be at higher risk for neurologic complications and should be monitored closely,” Freeman added.

Investigators in the Perelman School of Medicine at the University of Pennsylvania evaluated 81 COVID-19 patients through head CT and/or MRI brain scans; the most common reasons for a brain scan were altered mental state and focal neurologic deficits, such as speech and vision problems. Eighteen patients showed emergency or critical neurologic complications, including strokes, brain bleeds, and blocked blood vessels, according to investigators.

The study also demonstrated that Black patients with COVID-19 should also be closely monitored, as two-thirds of patients who showed critical results were Black.

In addition to evaluating neurological complication incidence in COVID-19 patients with hypertension and type 2 diabetes, the study also aims to understand these complications on patients receiving extracorporeal membrane oxygenation (ECMO).

“We have plans to initiate a larger prospective study evaluating delayed, long-term and chronic neurologic manifestations that may not be known in this early period in the pandemic,” Freeman said.

1. Diabetes, hypertension may increase risk of COVID-19 brain complications. News Release. Radiological Society of America; November 18, 2020. Accessed November 24, 2020. 

http://press.rsna.org/timssnet/media/pressreleases/14_pr_target.cfm?ID=2226

A study to be presented at the annual meeting of the Radiological Society of North America reported that COVID-19 patients with diabetes and hypertension may have a higher risk for neurologic complications.

Study: Diabetes, Hypertension May Increase Risk of COVID-19 Brain Complications

The FDA has approved baloxavir marboxil (Xofluza; Genentech) to prevent influenza in individuals 12 years of age and older following contact with a person infected with the flu, making it the first single-dose influenza medicine approved for post-exposure prophylaxis.

Baloxavir marboxil is currently available in the United States and several other countries for the treatment of influenza types A and B; the drug was the first new antiviral to be approved by the FDA in 20 years. The medication is an antiviral designed to inhibit the cap-dependent endonuclease protein essential for viral replication.

Since 2010, the CDC has estimated that influenza causes between 9 to 45 million illnesses, 140,000 to 810,000 hospitalizations, and 12,000 to 61,000 deaths each year. Beyond vaccines, Genentech stressed the need for new medical options for the prophylaxis and treatment of influenza.

Approval was based on the phase 3, double-blind, multicenter, randomized, placebo controlled BLOCKSTONE study recently published in 

 Investigators compared baloxavir marboxil with placebo in adult and children household members who had been living with someone with confirmed influenza.

Investigators ran the phase 3 clinical trial amid the 2018-2019 influenza season in Japan and reported a statistically significant prophylactic effect on influenza after administering 1 oral dose to the infected household member. One percept of the participants treated with baloxavir marboxil developed influenza compared with 13% of participants receiving placebo.

In addition, analysis of the study did not show any new safety signals. The most frequent adverse events (AEs) included diarrhea (3%), bronchitis (3%), nausea (2%), sinusitis (2%), and headache (1%).

With the coronavirus disease 2019 (COVID-19) pandemic coinciding with the 2020-2021 influenza season, this approval of baloxavir marboxil may play a key part in keeping viral infections down in the US.

“With today’s approval, Xofluza is now available as the first single-dose, post-exposure preventive treatment for influenza,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development. “We’re hopeful that reducing the burden of influenza may help to mitigate the strain on our healthcare system amid the COVID-19 pandemic.”

Genentech Announces FDA Approval of Xofluza for the Prevention of Influenza Following Contact With an Infected Person. News Release. Genentech; November 23, 2020. Accessed November 23, 2020. 

https://www.gene.com/media/press-releases/14885/2020-11-23/genentech-announces-fda-approval-of-xofl

Baloxavir marboxil (Xofluza; Genentech) is the first single-dose influenza medicine approved for post-exposure prophylaxis. 