What is known and objective The underlying pathophysiology of autism spectrum disorder (ASD) has been linked to immune dysregulation, oxidative stress and excitation‐inhibition imbalance. Among associated symptoms of ASD, management of irritability has gained considerable attention as it complicates adjustment of ASD patients and thus necessitates its pharmacological treatment. Resveratrol is a plant phytoalexin, which has been demonstrated to have neuroprotective effects through its anti‐inflammatory and antioxidant properties. This double‐blind, placebo‐controlled randomized trial was designed to assess the potential therapeutic effects of resveratrol plus risperidone on irritability of ASD patients. Methods Sixty‐two patients were assigned randomly into two groups of resveratrol and placebo. Both groups were treated with risperidone twice daily starting at a dose of 0.5 mg with a dose increase of 0.5 mg per week (for the first 3 weeks). Resveratrol dosage was 250 mg twice per day from the beginning of the study. Using the Aberrant Behavior Checklist‐Community (ABC‐C), patients were assessed for ASD‐related behavioural symptoms at baseline, week 5 and week 10. The frequency of adverse events was recorded using a checklist containing 25 possible side effects, including general, gastrointestinal, neurological and cardiovascular complications. Results and discussion Improvements in primary outcome measure (irritability) and three secondary outcome measures (lethargy/social withdrawal, stereotypic behaviour and inappropriate speech subscales) in the resveratrol group were statistically similar to those in the placebo group. The repeated measures analysis showed no time × treatment interaction on these subscale scores. In contrast, patients in the resveratrol group showed greater decline in hyperactivity/non‐compliance score as a secondary outcome measure (mean difference [CI = 95%] = 4.51 [0.10‐8.92], t = 2.04; P = .04), and repeated measures analysis showed significant effect for time × treatment effect on this subscale score (F = 3.81; df = 1.30; P = .043). There was no significant difference in number and severity of adverse events between the two groups. What is new and conclusion This clinical trial demonstrated no significant effect for adjunctive treatment with resveratrol on irritability of patients with ASD. However, it provided preliminary evidence indicating that resveratrol could improve hyperactivity/non‐compliance of ASD patients.
Background: Studies showed that the adherence to practice guidelines is associated with a higher quality of care and better patient’s outcomes. In psychiatric practice, there is a quality gap between Practice guidelines (PGs) and routine clinical practice for the patients with schizophrenia which potentially hinders their recovery. One of the important reasons for this persistent gap is the lack of systematic methods to evaluate prescribers’ adherence to practice guidelines. Objectives: This study aimed to develop and validate a medication assessment tool (MAT) to evaluate prescribers’ adherence to pharmacotherapy recommendations in PGs during the acute phase of schizophrenia (APSCZ) in Iran (MATAPSCZ). Methods: This methodological cross-sectional study was conducted from August 2021 to April 2022. According to the literature review and discussions in the research group, an item pool of 91 items was developed. Then face and content validity of the scale were evaluated. Then, exploratory factor analysis (EFA) was used to specify the factor structure. At last, the reliability and responsiveness of the scale were assessed. The study sample consisted of 200 Iranian psychiatrists and final-year psychiatry residents. Results: Eleven items were merged in qualitative content validity. Then, sixteen and six items were excluded from the scale in terms of having low content validity ratios and corrected item-total correlation, respectively. In exploratory factor analysis, the remaining 48 items were classified into six factors, which included 50.1% of the total variance. Based on the results, Cronbach’s alpha, and McDonald’s omega of all factors were higher than 0.7, AIC was 0.2 to 0.4 for all factors, and the intraclass correlation coefficient for MATAPSCZ was 0.914. The standard error of measurement was ± 4.5, and the percentage of minimum detectable change for the tool was calculated to be 6.15%, which indicates its excellent responsiveness. Conclusions: The MATAPSCZ has acceptable psychometric properties and could be a useful tool to evaluate prescribers’ adherence to practice guidelines pharmacotherapy recommendations during the APSCZ.
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