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To describe changes in home food availability during early childhood, including modified, developmentally sensitive obesogenic scores, and to determine whether home food availability is associated with food and nutrient intakes of children concurrently, over time.
Design:
Data were drawn from the STRONG Kids 2 longitudinal, birth cohort to achieve the study objectives. Home food availability was assessed with the Home Food Inventory (HFI) and included fifteen food groups (e.g. fruit and vegetables) and three obesogenic scores (one original and two modified). Food and nutrient intakes were measured using the Block FFQ and included twenty-seven food groups and eighteen nutrients (e.g. vitamins A and C, protein). HFI and FFQ were completed by trained researchers or mothers, respectively, at 24, 36 and 48 months. Repeated-measures ANOVA and Spearman’s correlations were used to achieve the study objectives.
Setting:
Central Illinois, USA.
Participants:
Participants were 468 children at 24, 36 and 48 months of age.
Results:
Availability of less nutritious foods and obesogenic foods and beverages increased as children aged, and availability of both nutritious and less nutritious foods were associated with child food and nutrient intake. The three obesogenic scores demonstrated similar, positive associations with the intake of energy, saturated fat, added sugars and kilocalories from sweets.
Conclusion:
These findings offer novel insight into changes in home food availability and associations with food and nutrient intake during early childhood. Additional attention is needed examining antecedents (e.g. built environments, purchasing behaviours) and consequences (e.g. child diet quality and weight) of home food availability.
Sensory differences and anxiety disorders are highly prevalent in autistic individuals with and without ADHD. Studies have shown that sensory differences and anxiety are associated and that intolerance of uncertainty (IU) plays an important role in this relationship. However, it is unclear as to how different levels of the sensory processing pathway (i.e., perceptual, affective, or behavioral) contribute. Here, we used psychophysics to assess how alterations in tactile perception contribute to questionnaire measures of sensory reactivity, IU, and anxiety. Thirty-eight autistic children (aged 8-12 years; 27 with co-occurring ADHD) were included. Consistent with previous findings, mediation analyses showed that child-reported IU fully mediated an association between parent-reported sensory reactivity and parent-reported anxiety and that anxiety partially mediated an association between sensory reactivity and IU. Of the vibrotactile thresholds, only simultaneous frequency discrimination (SFD) thresholds correlated with sensory reactivity. Interestingly, we found that sensory reactivity fully mediated an association between SFD threshold and anxiety, and between SFD threshold and IU. Taken together, those findings suggest a mechanistic pathway whereby tactile perceptual alterations contribute to sensory reactivity at the affective level, leading in turn to increased IU and anxiety. This stepwise association can inform potential interventions for IU and anxiety in autism.
Russian thistle (Salsola tragus L.) is among the most troublesome weeds in cropland and ruderal semiarid areas of the Pacific Northwest (PNW). Predicting S. tragus emergence timing plays a critical role in scheduling weed management measures. The objective of this research was to develop and validate a predictive model of the seedling emergence pattern of S. tragus under field conditions in the PNW to increase the efficacy of control measures targeting this species. The relationship between cumulative seedling emergence and cumulative hydrothermal time under field conditions was modeled using the Weibull function. This model is the first to use hydrothermal time units (HTT) to predict S. tragus emergence and showed a very good fit to the experimental data. According to this model, seedling emergence starts at 5 HTT, and 50% and 90% emergence is completed at 56 HTT and 177 HTT, respectively. For model validation, independent field experiments were carried out. Cumulative seedling emergence was accurately predicted by the model, supporting the idea that this model is robust enough to be used as a predictive tool for S. tragus seedling emergence. Our model can serve as the basis for the development of decision support systems, helping farmers make the best decisions to control S. tragus populations in no-till fallow and spring wheat systems.
Racially and ethnically minoritized populations have been historically excluded and underrepresented in research. This paper will describe best practices in multicultural and multilingual awareness-raising strategies used by the Recruitment Innovation Center to increase minoritized enrollment into clinical trials. The Passive Immunity Trial for Our Nation will be used as a primary example to highlight real-world application of these methods to raise awareness, engage community partners, and recruit diverse study participants.
The Rapid ASKAP Continuum Survey (RACS) is the first large sky survey using the Australian Square Kilometre Array Pathfinder (ASKAP), covering the sky south of $+41^\circ$ declination. With ASKAP’s large, instantaneous field of view, ${\sim}31\,\mathrm{deg}^2$, RACS observed the entire sky at a central frequency of 887.5 MHz using 903 individual pointings with 15 minute observations. This has resulted in the deepest radio survey of the full Southern sky to date at these frequencies. In this paper, we present the first Stokes I catalogue derived from the RACS survey. This catalogue was assembled from 799 tiles that could be convolved to a common resolution of $25^{\prime\prime}$, covering a large contiguous region in the declination range $\delta=-80^{\circ}$ to $+30^\circ$. The catalogue provides an important tool for both the preparation of future ASKAP surveys and for scientific research. It consists of $\sim$2.1 million sources and excludes the $|b|<5^{\circ}$ region around the Galactic plane. This provides a first extragalactic catalogue with ASKAP covering the majority of the sky ($\delta<+30^{\circ}$). We describe the methods to obtain this catalogue from the initial RACS observations and discuss the verification of the data, to highlight its quality. Using simulations, we find this catalogue detects 95% of point sources at an integrated flux density of $\sim$5 mJy. Assuming a typical sky source distribution model, this suggests an overall 95% point source completeness at an integrated flux density $\sim$3 mJy. The catalogue will be available through the CSIRO ASKAP Science Data Archive (CASDA).
Severe mental illness (SMI) is associated with increased stroke risk, but little is known about how SMI relates to stroke prognosis and receipt of acute care.
Aims
To determine the association between SMI and stroke outcomes and receipt of process-of-care quality indicators (such as timely admission to stroke unit).
Method
We conducted a cohort study using routinely collected linked data-sets, including adults with a first hospital admission for stroke in Scotland during 1991–2014, with process-of-care quality indicator data available from 2010. We identified pre-existing schizophrenia, bipolar disorder and major depression from hospital records. We used logistic regression to evaluate 30-day, 1-year and 5-year mortality and receipt of process-of-care quality indicators by pre-existing SMI, adjusting for sociodemographic and clinical factors. We used Cox regression to evaluate further stroke and vascular events (stroke and myocardial infarction).
Results
Among 228 699 patients who had had a stroke, 1186 (0.5%), 859 (0.4%), 7308 (3.2%) had schizophrenia, bipolar disorder and major depression, respectively. Overall, median follow-up was 2.6 years. Compared with adults without a record of mental illness, 30-day mortality was higher for schizophrenia (adjusted odds ratio (aOR) = 1.33, 95% CI 1.16–1.52), bipolar disorder (aOR = 1.37, 95% CI 1.18–1.60) and major depression (aOR = 1.11, 95% CI 1.05–1.18). Each disorder was also associated with marked increased risk of 1-year and 5-year mortality and further stroke and vascular events. There were no clear differences in receipt of process-of-care quality indicators.
Conclusions
Pre-existing SMI was associated with higher risks of mortality and further vascular events. Urgent action is needed to better understand and address the reasons for these disparities.
Cyberchondria involves excessive and uncontrollable online searching of information about a perceived illness. This behavior can cause or maintain distress.
Objectives
Little is known about cyberchondria during the COVID-19 pandemic or how cyberchondria in one individual may cause distress in their significant other if they are self-isolating together; our study sought to fill these gaps.
Methods
We conducted a Qualtrics Panel survey with 760 cohabitating Canadian couples; in June 2020, participants retrospectively reported on their cyberchondria behavior, general anxiety, and COVID-19 fears during the month of April 2020, while adhering to stay-at-home advisories. Two separate actor-partner interdependence models (APIMs) used cyberchondria excessiveness and compulsion to predict generalized anxiety and COVID-19 danger/contamination fears in the actor and partner.
Results
Both cyberchondria excessiveness and compulsion were associated with higher general anxiety and higher COVID-19 danger/contamination fears in the individual (actor effects). Partner cyberchondria compulsion was associated with higher general anxiety in the individual whereas partner cyberchondria excessiveness was associated with higher COVID-19 danger/contamination fears in the individual (partner effects).
Conclusions
Findings suggest that excessive and uncontrollable searching of information about COVID-19 on the internet during lockdown may contribute to distress in both the individual engaging in the cyberchondria behavior, and in their romantic partner. Moreover, different aspects of cyberchondria in the partner (compulsion vs. excessiveness) appears to contribute to general vs. COVID-19-specific anxiety/fears in the partner, respectively. Future research should examine mechanisms underlying the observed partner effects (e.g., co-rumination, social contagion) and reasons for the differential partner effects of cyberchondria components.
Recognizing the need for organizational change in a transition setting, we specify a research model entailing the effects of two important workplace variables on the relationship between dispositional resistance to change and organizational commitment. Organizational commitment is important because of its relationship with a host of considerations relevant to successful organizational change and development. We test the model with samples from four Ukrainian firms undergoing comparable substantive change, including in their human resource systems. The results indicate that the negative relationship between resistance to change and organization commitment is moderated by trust in management. Specifically, it is the lack of trust that exacerbates the negative influence of resistance to change on commitment. Also, high procedural justice strengthens the negative relationship, thereby reducing organizational commitment, an interesting divergence from the Western literature. These indigenous findings in a markedly different context from the West hold potential for theory that is richer and more comprehensive in its explanatory reach. The findings also provide useful insights for managers in Ukraine in their efforts to change organizational practices.
Previous research has suggested an association between depression and subsequent acute stroke incidence, but few studies have examined any effect modification by sociodemographic factors. In addition, no studies have investigated this association among primary care recipients with hypertension.
Methods
We examined the anonymized records of all public general outpatient visits by patients aged 45+ during January 2007–December 2010 in Hong Kong to extract primary care patients with hypertension for analysis. We took the last consultation date as the baseline and followed them up for 4 years (until 2011–2014) to observe any subsequent acute hospitalization due to stroke. Mixed-effects Cox models (random intercept across 74 included clinics) were implemented to examine the association between depression (ICPC diagnosis or anti-depressant prescription) at baseline and the hazard of acute stroke (ICD-9: 430–437.9). Effect modification by age, sex, and recipient status of social security assistance was examined in extended models with respective interaction terms specified.
Results
In total, 396 858 eligible patients were included, with 9099 (2.3%) having depression, and 10 851 (2.7%) eventually hospitalized for stroke. From the adjusted analysis, baseline depression was associated with a 17% increased hazard of acute stroke hospitalization [95% confidence interval (CI) 1.03–1.32]. This association was suggested to be even stronger among men than among women (hazard ratio = 1.29, 95% CI 1.00–1.67).
Conclusion
Depression is more strongly associated with acute stroke incidence among male than female primary care patients with hypertension. More integrated services are warranted to address their needs.
Public health monitoring is commonly undertaken in social media but has never been combined with data analysis from electronic health records. This study aimed to investigate the relationship between the emergence of novel psychoactive substances (NPS) in social media and their appearance in a large mental health database.
Methods
Insufficient numbers of mentions of other NPS in case records meant that the study focused on mephedrone. Data were extracted on the number of mephedrone (i) references in the clinical record at the South London and Maudsley NHS Trust, London, UK, (ii) mentions in Twitter, (iii) related searches in Google and (iv) visits in Wikipedia. The characteristics of current mephedrone users in the clinical record were also established.
Results
Increased activity related to mephedrone searches in Google and visits in Wikipedia preceded a peak in mephedrone-related references in the clinical record followed by a spike in the other 3 data sources in early 2010, when mephedrone was assigned a ‘class B’ status. Features of current mephedrone users widely matched those from community studies.
Conclusions
Combined analysis of information from social media and data from mental health records may assist public health and clinical surveillance for certain substance-related events of interest. There exists potential for early warning systems for health-care practitioners.
To update current estimates of non–device-associated pneumonia (ND pneumonia) rates and their frequency relative to ventilator associated pneumonia (VAP), and identify risk factors for ND pneumonia.
Design:
Cohort study.
Setting:
Academic teaching hospital.
Patients:
All adult hospitalizations between 2013 and 2017 were included. Pneumonia (device associated and non–device associated) were captured through comprehensive, hospital-wide active surveillance using CDC definitions and methodology.
Results:
From 2013 to 2017, there were 163,386 hospitalizations (97,485 unique patients) and 771 pneumonia cases (520 ND pneumonia and 191 VAP). The rate of ND pneumonia remained stable, with 4.15 and 4.54 ND pneumonia cases per 10,000 hospitalization days in 2013 and 2017 respectively (P = .65). In 2017, 74% of pneumonia cases were ND pneumonia. Male sex and increasing age we both associated with increased risk of ND pneumonia. Additionally, patients with chronic bronchitis or emphysema (hazard ratio [HR], 2.07; 95% confidence interval [CI], 1.40–3.06), congestive heart failure (HR, 1.48; 95% CI, 1.07–2.05), or paralysis (HR, 1.72; 95% CI, 1.09–2.73) were also at increased risk, as were those who were immunosuppressed (HR, 1.54; 95% CI, 1.18–2.00) or in the ICU (HR, 1.49; 95% CI, 1.06–2.09). We did not detect a change in ND pneumonia risk with use of chlorhexidine mouthwash, total parenteral nutrition, all medications of interest, and prior ventilation.
Conclusion:
The incidence rate of ND pneumonia did not change from 2013 to 2017, and 3 of 4 nosocomial pneumonia cases were non–device associated. Hospital infection prevention programs should consider expanding the scope of surveillance to include non-ventilated patients. Future research should continue to look for modifiable risk factors and should assess potential prevention strategies.
Viral pneumonia is an important cause of death and morbidity among infants worldwide. Transmission of non-influenza respiratory viruses in households can inform preventative interventions and has not been well-characterised in South Asia. From April 2011 to April 2012, household members of pregnant women enrolled in a randomised trial of influenza vaccine in rural Nepal were surveyed weekly for respiratory illness until 180 days after birth. Nasal swabs were tested by polymerase chain reaction for respiratory viruses in symptomatic individuals. A transmission event was defined as a secondary case of the same virus within 14 days of initial infection within a household. From 555 households, 825 initial viral illness episodes occurred, resulting in 79 transmission events. The overall incidence of transmission was 1.14 events per 100 person-weeks. Risk of transmission incidence was associated with an index case age 1–4 years (incidence rate ratio (IRR) 2.35; 95% confidence interval (CI) 1.40–3.96), coinfection as initial infection (IRR 1.94; 95% CI 1.05–3.61) and no electricity in household (IRR 2.70; 95% CI 1.41–5.00). Preventive interventions targeting preschool-age children in households in resource-limited settings may decrease the risk of transmission to vulnerable household members, such as young infants.
To update current estimates of non–device-associated urinary tract infection (ND-UTI) rates and their frequency relative to catheter-associated UTIs (CA-UTIs) and to identify risk factors for ND-UTIs.
Design:
Cohort study.
Setting:
Academic teaching hospital.
Patients:
All adult hospitalizations between 2013 and 2017 were included. UTIs (device and non-device associated) were captured through comprehensive, hospital-wide active surveillance using Centers for Disease Control and Prevention case definitions and methodology.
Results:
From 2013 to 2017 there were 163,386 hospitalizations (97,485 unique patients) and 1,273 UTIs (715 ND-UTIs and 558 CA-UTIs). The rate of ND-UTIs remained stable, decreasing slightly from 6.14 to 5.57 ND-UTIs per 10,000 hospitalization days during the study period (P = .15). However, the proportion of UTIs that were non–device related increased from 52% to 72% (P < .0001). Female sex (hazard ratio [HR], 1.94; 95% confidence interval [CI], 1.50–2.50) and increasing age were associated with increased ND-UTI risk. Additionally, the following conditions were associated with increased risk: peptic ulcer disease (HR, 2.25; 95% CI, 1.04–4.86), immunosuppression (HR, 1.48; 95% CI, 1.15–1.91), trauma admissions (HR, 1.36; 95% CI, 1.02–1.81), total parenteral nutrition (HR, 1.99; 95% CI, 1.35–2.94) and opioid use (HR, 1.62; 95% CI, 1.10–2.32). Urinary retention (HR, 1.41; 95% CI, 0.96–2.07), suprapubic catheterization (HR, 2.28; 95% CI, 0.88–5.91), and nephrostomy tubes (HR, 2.02; 95% CI, 0.83–4.93) may also increase risk, but estimates were imprecise.
Conclusion:
Greater than 70% of UTIs are now non–device associated. Current targeted surveillance practices should be reconsidered in light of this changing landscape. We identified several modifiable risk factors for ND-UTIs, and future research should explore the impact of prevention strategies that target these factors.
To evaluate long-term efficacy of deutetrabenazine in patients with tardive dyskinesia (TD) by examining response rates from baseline in Abnormal Involuntary Movement Scale (AIMS) scores. Preliminary results of the responder analysis are reported in this analysis.
Background
In the 12-week ARM-TD and AIM-TD studies, the odds of response to deutetrabenazine treatment were higher than the odds of response to placebo at all response levels, and there were low rates of overall adverse events and discontinuations associated with deutetrabenazine.
Method
Patients with TD who completed ARM-TD or AIM-TD were included in this open-label, single-arm extension study, in which all patients restarted/started deutetrabenazine 12mg/day, titrating up to a maximum total daily dose of 48mg/day based on dyskinesia control and tolerability. The study comprised a 6-week titration and a long-term maintenance phase. The cumulative proportion of AIMS responders from baseline was assessed. Response was defined as a percent improvement from baseline for each patient from 10% to 90% in 10% increments. AlMS score was assessed by local site ratings for this analysis.
Results
343 patients enrolled in the extension study (111 patients received placebo in the parent study and 232 patients received deutetrabenazine). At Week 54 (n=145; total daily dose [mean±standard error]: 38.1±0.9mg), 63% of patients receiving deutetrabenazine achieved ≥30% response, 48% of patients achieved ≥50% response, and 26% achieved ≥70% response. At Week 80 (n=66; total daily dose: 38.6±1.1mg), 76% of patients achieved ≥30% response, 59% of patients achieved ≥50% response, and 36% achieved ≥70% response. Treatment was generally well tolerated.
Conclusions
Patients who received long-term treatment with deutetrabenazine achieved response rates higher than those observed in positive short-term studies, indicating clinically meaningful long-term treatment benefit.
Presented at: American Academy of Neurology Annual Meeting; April 21–27, 2018, Los Angeles, California, USA.
Funding Acknowledgements: This study was supported by Teva Pharmaceuticals, Petach Tikva, Israel.
To evaluate the long-term safety and tolerability of deutetrabenazine in patients with tardive dyskinesia (TD) at 2years.
Background
In the 12-week ARM-TD and AIM-TD studies, deutetrabenazine showed clinically significant improvements in Abnormal Involuntary Movement Scale scores compared with placebo, and there were low rates of overall adverse events (AEs) and discontinuations associated with deutetrabenazine.
Method
Patients who completed ARM-TD or AIM-TD were included in this open-label, single-arm extension study, in which all patients restarted/started deutetrabenazine 12mg/day, titrating up to a maximum total daily dose of 48mg/day based on dyskinesia control and tolerability. The study comprised a 6-week titration period and a long-term maintenance phase. Safety measures included incidence of AEs, serious AEs (SAEs), and AEs leading to withdrawal, dose reduction, or dose suspension. Exposure-adjusted incidence rates (EAIRs; incidence/patient-years) were used to compare AE frequencies for long-term treatment with those for short-term treatment (ARM-TD and AIM-TD). This analysis reports results up to 2 years (Week106).
Results
343 patients were enrolled (111 patients received placebo in the parent study and 232 received deutetrabenazine). There were 331.4 patient-years of exposure in this analysis. Through Week 106, EAIRs of AEs were comparable to or lower than those observed with short-term deutetrabenazine and placebo, including AEs of interest (akathisia/restlessness [long-term EAIR: 0.02; short-term EAIR range: 0–0.25], anxiety [0.09; 0.13–0.21], depression [0.09; 0.04–0.13], diarrhea [0.06; 0.06–0.34], parkinsonism [0.01; 0–0.08], somnolence/sedation [0.09; 0.06–0.81], and suicidality [0.02; 0–0.13]). The frequency of SAEs (EAIR 0.15) was similar to those observed with short-term placebo (0.33) and deutetrabenazine (range 0.06–0.33) treatment. AEs leading to withdrawal (0.08), dose reduction (0.17), and dose suspension (0.06) were uncommon.
Conclusions
These results confirm the safety outcomes seen in the ARM-TD and AIM-TD parent studies, demonstrating that deutetrabenazine is well tolerated for long-term use in TD patients.
Presented at: American Academy of Neurology Annual Meeting; April 21–27, 2018, Los Angeles, California,USA
Funding Acknowledgements: Funding: This study was supported by Teva Pharmaceuticals, Petach Tikva, Israel
One-dimensional swelling tests and hydraulic conductivity tests have been performed at vertical effective stresses up to 450 kPa on Na-bentonite powder and compacted sand/Na-bentonite mixtures (5, 10 and 20% bentonite by weight) to investigate the use of bentonite-improved soils for waste containment. It was found that bentonite powder swells to reach a final state described by a single straight line on a plot of void ratio against the logarithm of vertical effective stress, regardless of preparation technique. Swelling of sand/bentonite mixtures expressed in terms of the clay void ratio show a deviation from bentonite behaviour above a stress which depends on the bentonite content. Hydraulic conductivity data for bentonite and sand/bentonite mixtures indicate an approximately linear relationship between logarithm of hydraulic conductivity and logarithm of void ratio. A design model based on the clay void ratio, and the sand porosity and tortuosity is presented enabling the hydraulic conductivity of a mixture to be estimated.
Aeroacoustic measurements and analysis have been made for an unshrouded rotor partially immersed in a planar equilibrium turbulent boundary layer at low Mach number. This configuration provides an idealized model of inflow distortion effects seen when a rotor is mounted adjacent to the hull or fuselage of a vehicle. At low and moderate thrust conditions, the rotor produces broadband noise organized into haystacks produced by large eddies of the ingested turbulence being cut multiple times by successive rotor blades. At high thrust, however, the acoustic signature changes and becomes louder and more tonal. This change is accompanied by separation of the boundary layer from the wall in the vicinity of the rotor blade disk. The separation region is highly unsteady and populated by intense vortex structures. Acoustic analysis suggests that blade–vortex interactions with these structures are the source of the additional tonal noise at high thrust.
In the 12-week ARM-TD and AIM-TD studies, deutetrabenazine showed clinically significant improvements in Abnormal Involuntary Movement Scale (AIMS) scores at Week 12 compared with placebo, and was generally well tolerated.
Objective
To evaluate the long-term safety/tolerability and efficacy of deutetrabenazine in patients with TD. Week 54 open-labelresults are reported in this interim analysis.
Methods
Patients with TD who completed ARM-TD or AIM-TD were included in this open-label, single-arm extension study, in which all patients restarted/started deutetrabenazine 12 mg/day, titrating up to a maximum total daily dose of 48 mg/day based on dyskinesia control and tolerability. The study comprised a 6-week titration period and a long-term maintenance phase. Safetymeasures included incidence of adverse events (AEs), serious AEs (SAEs), drug-related AEs, and AEs leading to withdrawal, dose reduction, or dose suspension. This analysis reports results up to Week 54.
Results
304 patients enrolled in the extension study. There were 215 patient-years of exposure in this analysis, and exposure-adjusted incidence rates (EAIRs) of AEs (incidence/patient-years) were comparable to or lower than those observed with short-term deutetrabenazine treatment and placebo. The frequency of SAEs (EAIR 0.14) was similar to rates observed with short-termplacebo (EAIR 0.33) and deutetrabenazine (EAIR range 0.06–0.33) treatment. AEs leading to study discontinuation (EAIR 0.08), dose reduction (EAIR 0.17), and dose suspension (EAIR 0.09) were uncommon.
Conclusions
Long-term treatment with deutetrabenazine was generally safe and well tolerated in patients with TD, and did not result in cumulative toxicity.
Presented at: The American Psychiatric Association 2017 Annual Meeting; May 20–24, 2017; San Diego, California, USA.
Funding Acknowledgements
This study was funded by Teva Pharmaceutical Industries, Petach Tikva, Israel.
Tardive dyskinesia (TD) is an involuntary movement disorder resulting from exposure to dopamine-receptor antagonists. In the 12-week ARM-TD and AIM-TD studies, deutetrabenazine demonstrated significant improvements in Abnormal Involuntary Movement Scale (AIMS) scores at Week 12 compared with placebo, and was generally well tolerated.
Objective
To evaluate the efficacy and safety of long-term deutetrabenazine therapy in patients with TD.
Methods
Patients with TD who completed the ARM-TD or AIM-TD studies were eligible to enter this open-label, single-arm, long-term safety study after they completed the 1-week washout period and final evaluation in the blinded portion of the trial. Efficacy endpoints included the change in AIMS score from baseline, and treatment success (defined as “much improved” or “very much improved”) on the Clinical Global Impression of Change (CGIC) and Patient Global Impression of Change (PGIC). This analysis reports results up to Week 54.
Results
304 patients enrolled in the extension study. At Week 54, the mean (standard error) change in AIMS score was –5.1 (0.52). After 6 weeks of deutetrabenazine treatment, the proportion of patients who achieved treatment success was 58% per the CGIC and 53% per the PGIC, and by Week 54 was 72% per the CGIC and 59% per the PGIC, thus demonstrating maintenance or enhancement of benefit over time. Deutetrabenazine was well tolerated for up to 54 weeks, and compared with the ARM-TD and AIM-TD studies, no new safety signals were detected.
Conclusions
54 weeks of deutetrabenazine treatment was generally efficacious, safe, and well tolerated in patients with TD.
Presented at: The American Psychiatric Association 2017 Annual Meeting; May 20–24, 2017; San Diego, California, USA.
Funding Acknowledgements
This study was funded by Teva Pharmaceutical Industries, Petach Tikva, Israel.