Viloxazine ER (extended-release capsules; Qelbree®) is a nonstimulant medication, FDA-approved for ADHD in children (≥6 years) and adults. Efficacy and safety for children and adolescents were evaluated in one phase 2 [NCT02633527]and four phase 3 [NCT03247517, NCT03247556, NCT03247530, and NCT03247543], double-blind (DB), placebo-controlled trials that fed into a long-term, open-label extension (OLE) trial [NCT02736656]. Here we report the findings from this OLE trial.

Participants completing the DB trials were eligible for the OLE. Viloxazine ER was initiated at 100 mg/day (children) or 200 mg/day (adolescents) and adjusted (if needed) over a 12-week Dose-Optimization Period (up to 400 mg/day [children] or 600 mg/day [adolescents]). Maintenance treatment then continued up to 72 months. Safety assessments included adverse events (AEs), clinical laboratory tests, vital signs, ECG (12-lead), and the Columbia Suicide Severity Rating Scale (C-SSRS). Efficacy assessments included the ADHD Rating Scale, 4th (Phase 2) or 5th (Phase 3) Edition (ADHD-RS-IV/5), and the Clinical Global Impression-Improvement (CGI-I) scale. Efficacy was assessed relative to DB baseline at study visits ˜ 3 months apart. Two response measures, 50% improvement in ADHD-RS-IV/5 Total score and CGI-I score of 1-2, were also evaluated.

1100 individuals (646 children; 454 adolescents; 66.5% male/33.5% female) received treatment. Median (range) exposure to viloxazine ER was 260 (1 to 1896) days. AEs were reported by 57.3% participants, most commonly (≥5%) nasopharyngitis (9.7%), somnolence (9.5%), headache (8.9%) decreased appetite (6.0%), and fatigue (5.7%). AEs were mostly mild or moderate in severity (3.9% reported any severe AE); AEs led to viloxazine ER discontinuation for 8.2%. The mean (SD) changes from DB baseline in ADHD-RS IV/5 Total score were -17.0 (14.18) (viloxazine ER) and -11.2 (13.19) (placebo) at the last DB study visit, 24.3 (11.96) at OLE Month 3, and 22.4 (13.62) at participants’ last OLE study visit. ADHD-RS-IV/5 and CGI-I responder rates each exceeded 65% at all OLE visits following Dose-Optimization.

The safety and efficacy of viloxazine ER were maintained with long-term use in children and adolescents with ADHD. No new safety concerns emerged, and efficacy results suggested potential for continued improvement over that seen during DB treatment.

Supernus Pharmaceuticals, Inc.

To identify factors that affected well-being among British embassy staff based in Japan after the 2011 earthquake, tsunami, and nuclear meltdown.

In-depth qualitative interviews were conducted with 36 members of staff 8 to 9 months after the earthquake.

Participants described their crisis work as stressful, exciting, and something of which they were proud. Aside from disaster-specific stressors, factors identified as stressful included unclear roles, handing over work to new personnel, being assigned to office-based work, feeling that work was not immediately beneficial to the public, not taking good-quality breaks, and difficulties with relatives. The radiation risk provoked mixed feelings, with most participants being reassured by contact with senior scientists.

Interventions to safeguard the well-being of personnel during crisis work must consider the impact of a broad range of stressors.(Disaster Med Public Health Preparedness. 2014;0:1-7)

The aim of this study was to enhance public health preparedness for incidents that involve the large-scale release of a hazardous substance by examining factors likely to influence public responses to official guidance on how to limit their exposure.

An online demographically representative survey was conducted in the United Kingdom (n = 601) and Poland (n = 602) to test the strength of association of trust in authorities, anxiety, threat, and coping appraisals with the intention to comply with advice to shelter in place following a hypothetical chemical spill. The impact of ease of compliance and style of message presentation were also examined.

Participants were more likely to comply if at home when the incident happened, but message presentation had little impact. Coping appraisals and trust were key predictors of compliance, but threat appraisals were associated with noncompliance. Anxiety was seen to promote behavioral change. UK participants were more likely to comply than Polish participants.

Successful crisis communications during an emergency should aim to influence perceptions regarding the efficacy of recommended behaviors, the difficulties people may have in following advice, and perceptions about the cost of following recommended behaviors. Generic principles of crisis communication may need adaptation for national contexts. (Disaster Med Public Health Preparedness. 2013;7:65-74)

Incidents involving the exposure of large numbers of people to radiological material can have serious consequences for those affected, their community and wider society. In many instances, the psychological effects of these incidents have the greatest impact. People fear radiation and even incidents which result in little or no actual exposure have the potential to cause widespread anxiety and behavior change. The aim of this study was to assess public intentions, beliefs and information needs in the UK and Germany in response to a hidden radiological exposure device. By assessing how the public is likely to react to such events, strategies for more effective crisis and risk communication can be developed and designed to address any knowledge gaps, misperceptions and behavioral responses that are contrary to public health advice.

This study had three stages. The first stage consisted of focus groups which identified perceptions of and reactions to a covert radiological device. The incident was introduced to participants using a series of mock newspaper and broadcast injects to convey the evolving scenario. The outcomes of these focus groups were used to inform national telephone surveys, which quantified intended behaviors and assessed what perceptions were correlated with these behaviors. Focus group and survey results were used to develop video and leaflet communication interventions, which were then evaluated in a second round of focus groups.

In the first two stages, misperceptions about the likelihood and routes of exposure were associated with higher levels of worry and greater likelihood of engaging in behaviors that might be detrimental to ongoing public health efforts. The final focus groups demonstrated that both types of misunderstanding are amenable to change following targeted communication.

Should terrorists succeed in placing a hidden radiological device in a public location, then health agencies may find that it is easier to communicate effectively with the public if they explicitly and clearly discuss the mechanisms through which someone could be affected by the radiation and the known geographical spread of any risk. Messages which explain how the risk from a hidden radiological device “works” should be prepared and tested in advance so that they can be rapidly deployed if the need arises.

PearceJM, RubinGJ, SelkeP, AmlôtR, MowbrayF, RogersMB. Communicating with the Public Following Radiological Terrorism: Results from a Series of Focus Groups and National Surveys in Britain and Germany. Prehosp Disaster Med. 2013;28(2):1-10.

The 2011 earthquake and tsunami in Japan caused a meltdown at the Fukushima nuclear power plant.

To quantify emotional responses among British nationals in Japan and to assess whether perceptions about the incident or accessing information about it were associated with responses.

A total of 284 participants randomly selected from official records completed a survey that included instruments to measure emotional responses.

In total, 16% met the criteria for distress, 29.7% reported high anxiety relating to the incident and 30.4% reported high anger. Perceptions that strongly predicted these outcomes included feeling uncertain, being unable to rule out harmful exposure, and believing that exposure would have severe or hidden health effects or be difficult to detect. Using information sources was associated with higher emotional outcome, particularly for sources perceived to have low credibility.

Reducing uncertainty and improving the credibility of information is essential in reducing the psychological impact of radiological disasters.

Terrorist attacks can have psychological effects on the general public.

To assess the medium-term effects of the July 2005 London bombings on the general population in London and to identify risk factors for persistent effects.

We telephoned 1010 Londoners 11–13 days after the bombings to assess stress levels, perceived threat and travel intentions. Seven months later, 574 respondents were contacted again and asked similar questions, and questions concerning altered perceptions of self and the world.

‘Substantial stress' (11%), perceived threat to self (43%) and reductions in travel because of the bombings (19%) persisted at a reduced level; other perceived threats remained unchanged. A more negative world view was common. Other than degree of exposure to the bombings, there were no consistent predictors of which people with short-term reactions would develop persistent reactions.

A longer-term impact of terrorism on the perceptions and behaviour of Londoners was documented.