1,659 research outputs found

    Sertraline for anxiety in adults with a diagnosis of autism (STRATA) : study protocol for a pragmatic, multicentre, double-blind, placebo-controlled randomised controlled trial

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    Background: Selective serotonin reuptake inhibitors (SSRIs) are commonly prescribed to manage anxiety in adults with an autism diagnosis. However, their effectiveness and adverse effect profile in the autistic population are not well known. This trial aims to determine the effectiveness and cost-effectiveness of the SSRI sertraline in reducing symptoms of anxiety and improving quality of life in adults with a diagnosis of autism compared with placebo and to quantify any adverse effects. Methods: STRATA is a two-parallel group, multi-centre, pragmatic, double-blind, randomised placebo-controlled trial with allocation at the level of the individual. It will be delivered through recruiting sites with autism services in 4 regional centres in the United Kingdom (UK) and 1 in Australia. Adults with an autism diagnosis and a Generalised Anxiety Disorder Assessment (GAD-7) score ≥ 10 at screening will be randomised 1:1 to either 25 mg sertraline or placebo, with subsequent flexible dose titration up to 200 mg. The primary outcome is GAD-7 scores at 16 weeks post-randomisation. Secondary outcomes include adverse effects, proportionate change in GAD-7 scores including 50% reduction, social anxiety, obsessive-compulsive symptoms, panic attacks, repetitive behaviours, meltdowns, depressive symptoms, composite depression and anxiety, functioning and disability and quality of life. Carer burden will be assessed in a linked carer sub-study. Outcome data will be collected using online/paper methods via video call, face-to-face or telephone according to participant preference at 16, 24 and 52 weeks post-randomisation, with brief safety checks and data collection at 1–2, 4, 8, 12 and 36 weeks. An economic evaluation to study the cost-effectiveness of sertraline vs placebo and a QuinteT Recruitment Intervention (QRI) to optimise recruitment and informed consent are embedded within the trial. Qualitative interviews at various times during the study will explore experiences of participating and taking the trial medication. Discussion: Results from this study should help autistic adults and their clinicians make evidence-based decisions on the use of sertraline for managing anxiety in this population. Trial registration: ISRCTN, ISRCTN15984604. Registered on 08 February 2021. EudraCT 2019-004312-66. ANZCTR ACTRN12621000801819. Registered on 07 April 2021

    Donepezil alone and combined with intensive language-action therapy on depression and apathy in chronic post-stroke aphasia: A feasibility study

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    This study explored the feasibility and effectiveness of a short-term (10-week) intervention trial using Donepezil administered alone and combined with intensive language action therapy (ILAT) for the treatment of apathy and depression in ten people with chronic post-stroke aphasia. Outcome measures were the Western Aphasia Battery and the Stroke Aphasia Depression Questionnaire-21. Structural magnetic resonance imaging and 18fluorodeoxyglucose positron emission tomography were acquired at baseline and after two endpoints (Donepezil alone and Donepezil-ILAT). The intervention was found to be feasible to implement. Large treatment effects were found. Donepezil alone and combined with ILAT reduced aphasia severity, while apathy and depression only improved with Donepezil-ILAT. Structural and functional neuroimaging data did not show conclusive results but provide hints for future research. Given these overall positive findings on feasibility, language and behavioral benefits, further studies in larger sample sizes and including a placebo-control group are indicated

    Temporal Trends in Mortality Associated with Comorbid Type 2 Diabetes and Schizophrenia: The Fremantle Diabetes Study

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    Background: In Phase I of the community-based Fremantle Diabetes Study (FDS1), there was evidence of a deleterious interactive effect of schizophrenia and type 2 diabetes on mortality. Our aim was to investigate whether the mortality gap had improved in FDS Phase II (FDS2) conducted 15 years later. Methods: Participants with type 2 diabetes from FDS1 (n = 1291 recruited 1993–1996) and FDS2 (n = 1509 recruited 2008–2011) were age-, sex- and postcode-matched 1:4 to people without diabetes. Schizophrenia at entry and incident deaths were ascertained from validated administrative data. Results: Schizophrenia affected 50/11,195 (0.45%) of participants without diabetes and 17/2800 (0.61%) of those with type 2 diabetes (p = 0.284). During 142,304 person-years of follow-up, the mortality rate (95% CI) was lowest for the FDS2 subgroup without diabetes/schizophrenia (18.2 (16.9, 19.6)/1000 person-years) and highest in FDS2 and FDS1 subgroups with type 2 diabetes/schizophrenia (53.3 (14.5, 136.6) and 98.0 (31.8, 228.8)/1000 person-years, respectively). Compared to the respective FDS subgroup without diabetes/schizophrenia, the mortality rate ratio was approximately 50% higher in the type 2 diabetes subgroup, and three times higher in those with type 2 diabetes/schizophrenia. In Cox regression, unadjusted hazard ratios were highest in those with type 2 diabetes/schizophrenia in FDS1 (HR (95% CI): 3.71 (1.54, 8.93) and FDS2 (2.96 (1.11, 7.91)), increasing to 5.61 (2.33, 13.5) and 26.9 (9.94, 72.6), respectively, after adjustment for age. Conclusions: Although limited by small numbers of schizophrenia cases, these data suggest that comorbid type 2 diabetes and schizophrenia remains associated with a substantial and possibly increasing mortality gap

    Donepezil alone and combined with intensive language-action therapy on depression and apathy in chronic post-stroke aphasia: A feasibility study

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    This study explored the feasibility and effectiveness of a short-term (10-week) intervention trial using Donepezil administered alone and combined with intensive language action therapy (ILAT) for the treatment of apathy and depression in ten people with chronic post-stroke aphasia. Outcome measures were the Western Aphasia Battery and the Stroke Aphasia Depression Questionnaire-21. Structural magnetic resonance imaging and 18fluorodeoxyglucose positron emission tomography were acquired at baseline and after two endpoints (Donepezil alone and Donepezil-ILAT). The intervention was found to be feasible to implement. Large treatment effects were found. Donepezil alone and combined with ILAT reduced aphasia severity, while apathy and depression only improved with Donepezil-ILAT. Structural and functional neuroimaging data did not show conclusive results but provide hints for future research. Given these overall positive findings on feasibility, language and behavioral benefits, further studies in larger sample sizes and including a placebo-control group are indicated.This work was supported as an independent research grant funded by Pfizer and Eisai. The funders were not involved in the study design, collection, analysis, or interpretation of the data. The work was also supported in part by the Ministerio de Economía, Industria y Competitividad, Instituto de Salud Carlos III, Spain (under Grant: PI16/01514; MLB and GD), and the Junta de Andalucía, Spain (under Grant: P20_00501; GD). MLB has been supported by funds from the European Social Fund (FEDER). LE and FJL-G have been funded by a PhD scholarship from the Spanish Ministry of Education, Culture, and Sport under the FPU program (FPU17/04136; FJL-G: FPU17/04470). DL-B was supported by I + D + i Project Andalusia and European Union Funds (FEDER) (UMA18-FEDERJA-221) and by Ramón y Cajal Program (RYC2020-029495-I) from the Spanish Ministry of Science and Innovation. MT-P has been funded by a postdoctoral fellowship under the program Plan Andaluz de Investigación, Desarrollo e Innovación (PAIDI 2020) (DOC_00421). FP and BM were supported by the Deutsche Forschungsgemeinschaft [Pu 97/15-1 and 15-2 to FP, Mo 697/5-2 to BM]. FP was also supported by the European Research Council [ERC-2019-ADG 883811] // Funding for open access charge: Universidad de Málaga / CBUA

    Measuring General Expectations of Advanced Stage Treatment Outcomes in Parkinson's Disease

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    Background: Recent research suggests that a significant number of those who receive advanced treatments for Parkinson's disease (PD) do not report improvements for some symptoms, which may relate to their pre-treatment expectations. It is important that expectations of treatment are measured and discussed prior to advanced treatment. Objective: The primary aim of this study was to develop a measure of treatment expectations of two advanced-stage treatments in PD, deep brain stimulation (DBS), and Levodopa/Carbidopa Intestinal Gel (LCIG). A secondary aim was to explore potential predictors of treatment expectations. Methods: The questionnaire-based measure was developed by researchers in conjunction with a highly experienced clinician, and evaluated treatment expectations in 189 people aged 46-91 years (M = 71.35, SD = 8.73; 61% male) with idiopathic PD. Results: The overall measure demonstrated excellent internal consistency (α= 0.96). Exploratory factor analysis suggested the scale was unidimensional for both DBS and LCIG. Participant expectations of the two treatments differed significantly, with expectations being higher for DBS. Perceived symptom severity was the strongest predictor of treatment expectations. Conclusion: This scale has potential to inform clinicians about client expectations prior to advanced stage therapy for PD, with a view to the management of these expectations. Further evaluation of the scale is required across different treatment contexts

    Behavioral psychological symptoms of dementia and functional connectivity changes: a network-based study

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    Behavioral and psychological symptoms of dementia (BPSD) are commonly observed since the early stage of Alzheimer's disease (AD) associated with structural brain changes. It is conceivable that they may also relate to functional brain changes. This resting-state functional MRI (RS-fMRI) study investigated the alterations within functional brain networks of a cohort of AD patients at different clinical stages who presented with BPSD. One hundred one AD patients and 56 patients with amnestic mild cognitive impairment underwent a neuropsychological evaluation including the Neuropsychiatry Inventory-12 (NPI-12). All patients and 35 healthy controls (HS) underwent 3T-MRI. Factor analysis was used to extract the principal factors from NPI-12, while RS-fMRI data were processed using graph theory to investigate functional connectivity. Five factors were extracted from NPI-12. Sixty-two percent of patients showed BPSD and functional brain connectivity changes in various networks compared to those without BPSD and HS. These changes contributed to account for patients' BPSD. This work opens new perspectives in terms of nonpharmacological interventions that might be designed to modulate brain connectivity and improve patients' BPSD
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