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The objective of this study was to evaluate the efficacy and safety of ziprasidone adjunctive to a mood stabilizer for the maintenance treatment of bipolar mania.
Male and female subjects with bipolar I disorder with MRS 3 14 were enrolled. Subjects achieving ≥ 8 consecutive weeks of stability with open-label ziprasidone (80-160 mg/d) and lithium or divalproex were randomized into the 6-month double-blind maintenance period, to ziprasidone + mood stabilizer or placebo + mood stabilizer. The primary and key secondary end points were the time to intervention for a mood episode, and time to discontinuation for any reason, respectively. Inferential analysis was performed using a Kaplan-Meier product-limit estimator (Log-rank test).
127 and 112 subjects were randomized to and treated in the ziprasidone and placebo groups, respectively. The time to intervention for a mood episode was significantly different, favoring ziprasidone (p = 0.0104). 19.7% and 32.4% of ziprasidone and placebo subjects, respectively, required intervention for a mood episode. Time to discontinuation for any reason was significantly different (p = 0.0047), favoring ziprasidone. Among treatment-emergent adverse events occurring in the double-blind period, the only event occurring more frequently in the ziprasidone group than in the placebo group (≥ 5%) was tremor (6.3% vs 3.6%, respectively).
These results demonstrate that ziprasidone is an effective, safe, and well-tolerated adjunctive treatment with a mood stabilizer for long-term maintenance treatment of bipolar mania.
The work was developed with the people hospitalized in the period of 1 year in a psychiatric clinic in Rio de Janeiro city, Brazil. 175 patients who presented dual diagnosis were evaluated.
The research aims to know the distribution of the most frequent psychiatric diagnosis associated with the disorders for the use of psychoactive substances. The work also has as objective to assess the treatment of patients carrying these disorders so that there is a better efficiency of the individual treatment plan.
The work consisted of the evaluation of all patients who were admitted to the clinic in the period of 1 year, using the ICD-10 for the diagnosis of dual pathologies. All the patients were assessed by the multiprofessional team, composed by general practicioner, psychiatrist, psychologist, pharmaceutic, therapist in chemical dependence, family therapist and physiotherapist. The patients were treated with the use of psychopharms, cognitive behavioral psychotherapy, 12-step program, art therapy and moderate physical activity. Family members of all patients were also interviewed.
In the evaluation conducted by the team, it was found the following distribution of the most frequent diagnosis associated to disorder for the use of psychoactive substances: depression (26.3%), personality disorder (22.9%), bipolar disorder (22.3%), non-schizophrenic psychosis (12.6%), schizophrenia (9.1%), and other diagnosis (6.8%).
The formulation of the dual diagnosis provided a better approach of the patients on the part of the team, promoting the strengthening of the therapeutic bond and causing positive impact on the evolution of these disorders.
Disclosure of interest
The authors have not supplied their declaration of competing interest.
We aimed to investigate the heterogeneity of seasonal suicide patterns among multiple geographically, demographically and socioeconomically diverse populations.
Weekly time-series data of suicide counts for 354 communities in 12 countries during 1986–2016 were analysed. Two-stage analysis was performed. In the first stage, a generalised linear model, including cyclic splines, was used to estimate seasonal patterns of suicide for each community. In the second stage, the community-specific seasonal patterns were combined for each country using meta-regression. In addition, the community-specific seasonal patterns were regressed onto community-level socioeconomic, demographic and environmental indicators using meta-regression.
We observed seasonal patterns in suicide, with the counts peaking in spring and declining to a trough in winter in most of the countries. However, the shape of seasonal patterns varied among countries from bimodal to unimodal seasonality. The amplitude of seasonal patterns (i.e. the peak/trough relative risk) also varied from 1.47 (95% confidence interval [CI]: 1.33–1.62) to 1.05 (95% CI: 1.01–1.1) among 12 countries. The subgroup difference in the seasonal pattern also varied over countries. In some countries, larger amplitude was shown for females and for the elderly population (≥65 years of age) than for males and for younger people, respectively. The subperiod difference also varied; some countries showed increasing seasonality while others showed a decrease or little change. Finally, the amplitude was larger for communities with colder climates, higher proportions of elderly people and lower unemployment rates (p-values < 0.05).
Despite the common features of a spring peak and a winter trough, seasonal suicide patterns were largely heterogeneous in shape, amplitude, subgroup differences and temporal changes among different populations, as influenced by climate, demographic and socioeconomic conditions. Our findings may help elucidate the underlying mechanisms of seasonal suicide patterns and aid in improving the design of population-specific suicide prevention programmes based on these patterns.
We present the first images of a coordinated campaign to follow active region NOAA 12709 on 2018 May 13 as part of a joint effort between three observatories (China-Europe). The active region was close to disk center and enclosed a small pore, a tight polarity inversion line and a filament in the chromosphere. The active region was observed with the 1.5-meter GREGOR solar telescope on Tenerife (Spain) with spectropolarimetry using GRIS in the He i 10830 Å spectral range and with HiFI using two broad-band filter channels. In addition, the Lomnicky Stit Observatory (LSO, Slovakia) recorded the same active region with the new Solar Chromospheric Detector (SCD) in spectroscopic mode at Hα 6562 Å. The third ground-based telescope was located at the Fuxian Solar Observatory (China), where the active region was observed with the 1-meter New Vacuum Solar Telescope (NVST), using the Multi-Channel High Resolution Imaging System at Hα 6562 Å. Overlapping images of the active region from all three telescopes will be shown as well as preliminary Doppler line-of-sight (LOS) velocities. The potential of such observations are discussed.
The aim of this study was to compare the effect of Hurricane Maria on internalizing and posttraumatic stress disorders (PTSD) among Puerto Ricans who moved to Florida after the storm versus those who stayed on the island.
In March through April 2018 (6 months after Hurricane Maria), an online survey was used to assess the effects of the storm on mental health. A sample of 213 displaced Puerto Ricans living in urban and rural/suburban areas in Florida, as well as urban and rural areas of Puerto Rico, participated in the study.
Rates of PTSD were high in both sites (Florida, 65.7%; Puerto Rico, 43.6%); however, participants in Florida were far more likely than those in Puerto Rico to meet diagnostic criteria for PTSD (OR, 2.94; 95% CI, 1.67-5.26). Among participants in both Florida and Puerto Rico, those living in urban areas were more likely than those in rural/suburban areas to meet criteria for PTSD and generalized anxiety disorder.
Results suggest that post-Hurricane Maria adjustment and adaptation may have been more psychologically taxing for Puerto Ricans who moved to Florida than it was for those who remained on the island, and more difficult for those in urban areas than it was for those in suburban or rural areas. (Disaster Med Public Health Preparedness. 2019;13:24–27)
This pilot study aimed to assess the community needs and population health status for the low-income town of Punta Santiago, situated on the southeastern coast of Puerto Rico at the point where Hurricane Maria made landfall on September 20, 2017.
A cross-sectional, interviewer-administered survey was conducted 6 months after the storm with a representative random sample of 74 households. The survey characterized population demographics and resident needs in relation to storm damage and disruption. The survey also assessed prevalence and symptom severity of major depression, generalized anxiety, and posttraumatic stress disorder.
Most of Punta Santiago was without electrical power and more than half of households sustained severe damage. Residents reported loss of jobs, decreased productivity, school closures, dependency on aid for basic necessities, increased risk for vector-borne diseases, unrelenting exposure to heat and humidity, and diminished health status. Two-thirds (66.2%) of the respondents had clinically significant symptom elevations for at least 1 of the 3 common mental disorders assessed: major depression, generalized anxiety, or posttraumatic stress disorder.
Pilot survey results, along with other studies conducted in Punta Santiago, can be used to provide guidance for interventions with this community as well as with other low-income, storm-affected areas. (Disaster Med Public Health Preparedness. 2019;13:18–23)
A great deal of research has focused on acculturation and enculturation, which represent the processes of adapting to a new culture. Despite this growing literature, results have produced inconsistent findings that may be attributable to differences in terms of the instruments used to assess acculturation and enculturation. Utilizing a 3-year longitudinal data set (with 1-year lags between assessments), the present study explored the psychometric properties of the Bicultural Involvement Questionnaire—Short Version (BIQ-S) and the Acculturation Rating Scale for Mexican Americans II (ARSMA-II) and examined the overlap between changes in these measures as they relate to internalizing and externalizing problem behavior. The present sample consisted of 216 immigrant Latino youth (43% boys; mean age 13.6 years at baseline; SD = 1.44 years, range 10 to 17). Exploratory structural equation modeling identified factor structures for the BIQ-S and ARSMA-II that diverged from their hypothesized structure. Growth curve models also indicate divergence between the BIQ-S and ARSMA-II in terms of change in acculturation and enculturation processes. Finally, the present findings emphasized that measures of acculturation and enculturation are not equivalent in terms of their effects on internalizing and externalizing problems.
The Indian residential school (IRS) system in Canada ran for over a century until the last school closed in 1996. Conditions in the IRSs resulted in generations of Indigenous children being exposed to chronic childhood adversity. The current investigation used data from the 2008–2010 First Nations Regional Health Survey to explore whether parental IRS attendance was associated with suicidal thoughts and attempts in childhood, adolescence and in adulthood among a representative sample of First Nations peoples living on-reserve across Canada. Analyses of the adult sample in Study 1 (unweighted n=7716; weighted n=186,830) revealed that having a parent who attended IRS was linked with increased risk for suicidal thoughts and attempts in adolescence and adulthood. Although females were negatively affected by having a parent who attended IRS, the link with suicidal ideation in adulthood was greater for males. Analyses of the youth sample in Study 2 (unweighted n=2883; weighted n=30,190) confirmed that parental IRS attendance was associated with an increased risk for suicidal ideation and attempts. In contrast to the adult sample, parental IRS attendance had a significantly greater relation with suicidal ideation among female youth. A significant interaction also emerged between parental IRS attendance and age in the youth sample, with the influence of parental attendance being particularly strong among youth ages 12–14, compared with those 15–17 years. These results underscore the need for culturally relevant early interventions for the large proportions of Indigenous children and youth intergenerationally affected by IRSs and other collective traumas.
Current standard-of-care for glioblastoma (GBM) includes surgery, radiation and temozolomide. Most tumors recur within a year from diagnosis and median survival for recurrent GBM (rGBM) is 3-9 months. Unmethylated promoter status for O6-methylguanine-DNA-methyltransferase (MGMT) is a validated biomarker for temozolomide-resistance, exhibited by most GBM patients. VAL-083 is a DNA-targeting agent with a mechanism-of-action that is independent of MGMT. VAL-083 overcomes temozolomide-resistance in GBM cell-lines, cancer stem cells, and in vivo models. VAL-083 readily crosses the blood-brain barrier and accumulates in brain-tumor tissue. We recently completed a VAL-083 dose-escalation trial in temozolomide- and bevacizumab-refractory rGBM and determined that 40mg/m2/day given intravenously on days 1,2,3 of a 21-day cycle is generally well-tolerated. This dosing regimen was selected for subsequent GBM trials, including an ongoing single-arm, biomarker-driven Phase 2 trial (N=48) in temolozomide-refractory, bevacizumab-naïve rGBM , MGMT-unmethylated (Clinicaltrials.gov:NCT02717962). The primary objective of this study is to determine if VAL-083 improves OS compared to a historical control of 7.15 months for MGMT-unmethylated rGBM patients treated with lomustine (EORTC26101). In addition, another single-arm, biomarker-driven, Phase 2 study (N=25) of VAL-083 in combination with radiotherapy in newly diagnosed GBM, MGMT-unmethylated is ongoing (Clinicaltrials.gov:NCT03050736). This trial aims to determine a dose for further study of VAL-083 in combination with radiotherapy and explore if VAL-083 improves PFS and OS compared to historical results in newly diagnosed GBM. Enrollment and safety data updates will be provided at the meeting. The results of these studies, if successful, may support VAL-083 as part of a new chemotherapeutic treatment paradigm for GBM.
Since 2006, Israel has been confronting an outbreak of carbapenem-resistant Enterobacteriaceae (CRE), and in 2007 Israel implemented a national strategy to contain spread. The intervention was initially directed toward acute-care hospitals and later expanded to include an established reservoir of carriage in long-term-care hospitals. It included regular reporting of CRE cases to a central registry and daily oversight of management of the outbreak at the institutional level. Microbiological methodologies were standardized in clinical laboratories nationwide. Uniform requirements for carrier screening and isolation were established, and a protocol for discontinuation of carrier status was formulated. In response to the evolving epidemiology of CRE in Israel and the continued need for uniform guidelines for carrier detection and isolation, the Ministry of Health in 2016 issued a regulatory circular updating the requirements for CRE screening, laboratory diagnosis, molecular characterization, and carrier isolation, as well as reporting and discontinuation of isolation in healthcare institutions nationwide. The principal elements of the circular are contained herein.
OBJECTIVES/SPECIFIC AIMS: Inflammatory bowel disease (IBD) patients are at an increased risk of Clostridium difficile infection (CDI) but the impact of CDI on disease severity is unclear. The aim of this study was to determine the effect of CDI on long-term disease outcome in a cohort of IBD patients. METHODS/STUDY POPULATION: We analyzed patients enrolled in a prospective IBD natural history registry. Patients who tested positive at least once formed the CDI positive group. We generated a 2:1 propensity matched control cohort based on risk factors of CDI in the year before infection. Healthcare utilization data (emergency department use, subsequent hospitalizations, telephone encounters), medications, labs, disease activity, and quality of life metrics were temporally organized. RESULTS/ANTICIPATED RESULTS: A total of 198 patients (66 CDI, 132 matched controls) were included [56.6% female; 60.1% Crohn’s disease (CD), 39.9% ulcerative colitis (UC)]. Groups were not significantly different in the year before infection in all metrics but in the year of infection, having CDI was significantly associated with more steroid and antibiotic exposure, elevated C-reactive protein or erythrocyte sedimentation rate, and low vitamin D (all p<0.01). Infection was associated with increased disease activity metrics (UC: p=0.036, CD: p=0.003), worse disease-related quality of life (p=0.003), and increased healthcare utilization (p<0.001). In the next year after infection those with prior CDI continued to have increased exposure to vancomycin or fidaxomicin (p<0.001) and all other antibiotics (p=0.01). They also continued to have more clinic visits (p=0.006), telephone encounters (p=0.001), and worse disease-related quality of life (p=0.03), but disease activity and biomarkers of severity were not significantly different between groups. DISCUSSION/SIGNIFICANCE OF IMPACT: CDI infection in IBD is significantly associated with various surrogate markers of disease severity, increased healthcare utilization and poor quality of life during the year of infection. CDI patients continue to experience poor quality of life after infection with increased clinic visits and antibiotic exposure while disease activity is no longer significantly increased. These findings suggest that CDI infection may have a lasting effect on healthcare utilization beyond the acute treatment period.
Thorium dioxide (thoria, ThO2) is used in refractory applications and as nuclear fuel. Its melting temperature, the highest of any binary oxide, makes it a difficult system to process. Here we report on the effects of flash sintering on the densification of thoria. We found 95% of theoretical density is obtained at ~950 °C (~30% of the melting temperature) with an electric field of 800 V/cm. Variation in power density had a minimal effect on the densification. Scanning electron microscopy images show the effects of flash sintering on grain size as a function of electric field.