Efficacy and Safety of ASP0819 in Patients with Fibromyalgia: Results of a Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial.

PURPOSE: ASP0819 is a novel, non-opioid KCa3.1 channel opener that reverses abnormal nerve firing of primary sensory afferent nerves. Currently available treatments for fibromyalgia provide only modest relief and are accompanied by a host of adverse side effects. PATIENTS AND METHODS: In this phase 2a, double-blind trial (NCT03056690), adults meeting fibromyalgia diagnostic criteria were randomized 1:1 to receive either 15 mg/day of oral ASP0819 (n=91) or placebo (n=95). The primary endpoint was the change from baseline to Week 8 in the mean daily average pain score. Changes in the Fibromyalgia Impact Questionnaire Revised (FIQR) symptoms, function, and overall impact subscales, as well as changes in the patients' global impression of change, were secondary endpoints; treatment effects on FIQR total score and impact on sleep were exploratory analyses. RESULTS: There was no statistically significant difference between ASP0819 and placebo for the primary endpoint (P=0.086); however, ASP0819 versus placebo significantly improved daily average pain at Weeks 2, 6, and 7 (all P<0.05). Numerical improvements were observed on the FIQR total score and several sleep items showed statistically significant improvements with ASP0819 versus placebo. There were no major safety concerns with ASP0819. Headache was the most common treatment-emergent adverse event (TEAE) occurring in both study arms; most TEAEs were mild or moderate in severity and no TEAEs suggestive of potential drug abuse were observed, as assessed by TEAE reporting and/or safety evaluations. Withdrawal effects also were not observed. CONCLUSION: ASP0819 demonstrated some signals suggestive of efficacy and had a good tolerability profile in patients with fibromyalgia. Further studies are required to determine if ASP0819 can be a novel non-opioid treatment option in this patient group. CLINICALTRIALSGOV REGISTRATION: NCT03056690.

Clinical Profiles of Young Adults With Juvenile-Onset Fibromyalgia With and Without a History of Trauma.

OBJECTIVE: To examine the differential presentation(s) of psychological and health-related outcomes in young adults with juvenile-onset fibromyalgia (FM) with and without a history of trauma, compared to healthy controls. METHODS: In total, 110 participants (86 with juvenile-onset FM and 24 healthy controls, with a mean age of 23.4 years) completed a structured clinical interview to assess for trauma and psychological comorbidities, as well as self-report questionnaires on pain, physical functioning, and health care utilization. RESULTS: Of the juvenile-onset FM participants, 37% (n = 32) reported a history of trauma. Three group comparisons (i.e., juvenile-onset FM with trauma versus juvenile-onset FM with no trauma versus healthy controls) revealed that juvenile-onset FM participants significantly differed from healthy controls on all psychological and health-related outcomes. Further, although juvenile-onset FM participants with and without a history of trauma did not significantly differ on pain and physical functioning, juvenile-onset FM participants with a history of trauma were significantly more likely to have psychological comorbidities. CONCLUSION: This is the first controlled study to examine the differential outcomes between juvenile-onset FM participants with and without a history of trauma. Group comparisons between juvenile-onset FM participants and healthy controls were consistent with previous research. Further, our findings indicate that juvenile-onset FM participants with a history of trauma experience greater psychological, but not physical, impairment than juvenile-onset FM participants without a history of trauma.

Redevelopment of tertiary psychiatric services in British Columbia: a prospective study of clinical, social, and residential outcomes of former long-stay inpatients.

OBJECTIVE: The objective of this study is to assess the clinical and social outcomes for a cohort of patients who were part of the redevelopment of psychiatric services in British Columbia. METHOD: This study used a naturalistic, quasi-experimental design, to examine the outcomes of a cohort of 189 long-stay patients at Riverview Hospital (RVH), some of whom moved into Tertiary Psychiatric Residential Facilities (TPRFs), some into the community in less structured facilities, and some remained at RVH. Data was collected from clinical files at RVH and at each participating site, semi-structured interviews and self-report measures were completed with patients. In addition, semi-structured interviews were also conducted with staff members. RESULTS: There was very minimal evidence of transinstitutionalization to prisons or homelessness; one participant resided in a correctional facility, one resided in a forensic facility, and one participant spent some time homeless. In addition, the majority of participants remained in residences that provided 24h care. Eighty percent of our population was diagnosed with a schizophrenia spectrum disorder. Psychiatric symptoms remained fairly stable; some embarrassing social behaviors increased; however, aggressive behaviors showed no increase; neuropsychological deficits did not deteriorate, there were even some improvements. Participants demonstrated increases in several independent living skills including: money management, food preparation and storage, job skills, and transportation skills. In addition, participants experienced a significant increase in their perceived quality of life. CONCLUSIONS: This study builds on existing research demonstrating that well-planned and appropriately resourced hospital closures can lead to positive psycho-social outcomes for participants and can successfully avoid negative outcomes such as transinstitutionalization to the judiciary system and homelessness.

Regionalised tertiary psychiatric residential facilities.

AIMS: Psychiatric hospitals remain the main venue for long-term mental health care and, despite widespread closures and downsizing, no country that built asylums in the last century has done away with them entirely--with the recent exception of Italy. Differentiated community-based residential alternatives have been developed over the past decades, with staffing levels that range from full-time professional, to daytime only, to part-time/on-call. METHODS: This paper reviews the characteristics of community-based psychiatric residential care facilities as an alternative to long-term care in psychiatric hospitals. It describes five factors decision makers should consider: 1. number of residential places needed; 2. staffing levels; 3. physical setting; 4. programming; and 5. governance and financing. RESULTS: In Italy, facilities with full-time professional staff have been developed since the mid-1990s to accommodate the last cohorts of patients discharged from psychiatric hospitals. In the United Kingdom, experiments with hostel wards since the 1980s have shown that home-like, small-scale facilities with intensive treatment and rehabilitation programming can be effective for the most difficult-to-place patients. More recently in Australia, Community Care Units (CCUs) have been applying this concept. In the Canadian province of British Columbia (BC), Tertiary Psychiatric Residential Facilities (TPRFs) have been developed as part of an effort to regionalise health and social services and downsize and ultimately close its only psychiatric hospital. CONCLUSIONS: This type of service must be further developed in addition to the need for forensic, acute-care and intermediate-level beds, as well as for community-based care such as assertive community treatment and intensive case management. All these types of services, together with long-term community-based residential care, constitute the elements of a balanced mental health care system. As part of a region's balanced mental health care plan, these Tertiary Psychiatric Care Facilities have the potential to act as hubs of expertise not only for treatment, rehabilitation, community integration and service co-ordination for the severely mentally ill, but also for research and training.