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Ethnic differences in antidepressant response: a prospective multi-site clinical trial.

ABSTRACT: BACKGROUND:Although depression is a highly prevalent condition that occurs in all ethnic groups, the influence of ethnicity on treatment response still remains unclear. METHODS:A prospective 8-week, open-label clinical trial comparing the efficacy and side effects of citalopram (CIT) with dose escalation (20-60 mg/day) was performed in African-Americans and Caucasians with nonpsychotic major depression. The intent-to-treat sample consisted of 301 participants (169 African-Americans and 132 Caucasians). RESULTS:Although African-Americans were more socially disadvantaged and had a more severe depression, outcomes between the groups were similar. Remission rates were approximately 50% in both groups and about 2/3 of participants met response criteria. Retention was greater than 75% in both groups, with no differences in dropout rate. There were no differences in the number of completers, number of visits made, final dose of CIT, or in side effect profiles. CONCLUSIONS:These results confirm the growing body of evidence, including recent studies using measurement-based care, that patients from minority groups have outcomes that are similar to those of Caucasians. The provision of measurement-based care and encouragement of patient participation can reduce ethnic differences in response to treatment for depression.

SUBMITTER: Lesser IM

PROVIDER: S-EPMC3113513 | biostudies-literature | 2010

REPOSITORIES: biostudies-literature

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Ethnic differences in antidepressant response: a prospective multi-site clinical trial.

Lesser Ira M IM Myers Hector F HF Lin Keh-Ming KM Bingham Mira Consuelo C Joseph Nataria T NT Olmos Natasha T NT Schettino Jonathan J Poland Russell E RE

Depression and anxiety 20100101 1

<h4>Background</h4>Although depression is a highly prevalent condition that occurs in all ethnic groups, the influence of ethnicity on treatment response still remains unclear.<h4>Methods</h4>A prospective 8-week, open-label clinical trial comparing the efficacy and side effects of citalopram (CIT) with dose escalation (20-60 mg/day) was performed in African-Americans and Caucasians with nonpsychotic major depression. The intent-to-treat sample consisted of 301 participants (169 African-American ...[more]

PMID: 19960492

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Project description:BACKGROUND:The Antenatal Corticosteroid Trial (ACT) assessed the feasibility, effectiveness, and safety of a multifaceted intervention to increase the use of antenatal corticosteroids (ACS) in mothers at risk of preterm birth at all levels of care in low and middle-income countries. The intervention effectively increased the use of ACS but had no overall impact on neonatal mortality in the targeted <5(th) percentile birth weight infants. Being in the intervention clusters was also associated with an overall increase in neonatal deaths. We sought to explore plausible pathways through which this intervention increased neonatal mortality. METHODS:We conducted secondary analyses to assess site differences in outcome and potential explanations for the differences in outcomes if found. By site, and in the intervention and control clusters, we evaluated characteristics of the mothers and care systems, the proportion of the <5(th) percentile infants and the overall population that received ACS, the rates of possible severe bacterial infection (pSBI), determined from clinical signs, and neonatal mortality rates. RESULTS:There were substantial differences between the sites in both participant and health system characteristics, with Guatemala and Argentina generally having the highest levels of care. In some sites there were substantial differences in the health system characteristics between the intervention and control clusters. The increase in ACS in the intervention clusters was similar among the sites. While overall, there was no difference in neonatal mortality among <5(th) percentile births between the intervention and control clusters, Guatemala and Pakistan both had significant reductions in neonatal mortality in the <5(th) percentile infants in the intervention clusters. The improvement in neonatal mortality in the Guatemalan site in the <5(th) percentile infants was associated with a higher level of care at the site and an improvement in care in the intervention clusters. There was a significant increase overall in neonatal mortality in the intervention clusters compared to the control. Across sites, this increase in neonatal mortality was statistically significant and most apparent in the African sites. This increase in neonatal mortality was accompanied by a significant increase in pSBI in the African sites. CONCLUSIONS:The improvement in neonatal mortality in the Guatemalan site in the <5(th) percentile infants was associated with a higher level of care and an improvement in care in the intervention clusters. The increase in neonatal mortality in the intervention clusters across all sites was largely driven by the poorer outcomes in the African sites, which also had an increase in pSBI in the intervention clusters. We emphasize that these results come from secondary analyses. Additional prospective studies are needed to assess the effectiveness and safety of ACS on neonatal health in low resource settings. TRIAL REGISTRATION: TRIAL REGISTRATION:clinicaltrials.gov (NCT01084096).

Project description:ContextResearch on vascular depression has used 2 approaches to subtype late-life depression, based on executive dysfunction or white matter hyperintensity severity.ObjectiveTo evaluate the relationship of neuropsychological performance and white matter hyperintensity with clinical response in late-life depression.DesignTwo-site, prospective, nonrandomized controlled trial.SettingOutpatient clinics at Washington University and Duke University.ParticipantsA total of 217 subjects aged 60 years or older met DSM-IV criteria for major depression, scored 20 or more on the Montgomery-Asberg Depression Rating Scale (MADRS), and received vascular risk factor scores, neuropsychological testing, and magnetic resonance imaging; they were excluded for cognitive impairment or severe medical disorders. Fazekas rating was conducted to grade white matter hyperintensity lesions. Intervention Twelve weeks of sertraline treatment, titrated by clinical response. Main Outcome Measure Participants' MADRS scores over time.ResultsBaseline neuropsychological factor scores correlated negatively with baseline Fazekas scores. A mixed model examined effects of predictor variables on MADRS scores over time. Baseline episodic memory (P = .002), language (P = .007), working memory (P = .01), processing speed (P < .001), executive function factor scores (P = .002), and categorical Fazekas ratings (P = .05) predicted MADRS scores, controlling for age, education, age of onset, and race. Controlling for baseline MADRS scores, these factors remained significant predictors of decrease in MADRS scores, except for working memory and Fazekas ratings. Thirty-three percent of subjects achieved remission (MADRS < or =7). Remitters differed from nonremitters in baseline cognitive processing speed, executive function, language, episodic memory, and vascular risk factor scores.ConclusionsComprehensive neuropsychological function and white matter hyperintensity severity predicted MADRS scores prospectively over a 12-week treatment course with selective serotonin reuptake inhibitors in late-life depression. Baseline neuropsychological function differentiated remitters from nonremitters and predicted time to remission in a proportional hazards model. Predictor variables correlated highly with vascular risk factor severity. These data support the vascular depression hypothesis and highlight the importance of linking subtypes based on neuropsychological function and white matter integrity.Trial registrationclinicaltrials.gov Identifier: NCT00045773.

Project description:BackgroundDifferent 25-hydroxyvitamin D [25(OH)D] thresholds for treatment with vitamin D supplementation have been suggested and are derived almost exclusively from observational studies. Whether other characteristics, including race/ethnicity, BMI, and estimated glomerular filtration rate (eGFR), should also influence the threshold for treatment is unknown.ObjectivesThe aim was to identify clinical and biomarker characteristics that modify the response to vitamin D supplementation.MethodsA total of 666 older adults in the Multi-Ethnic Study of Atherosclerosis (MESA) were randomly assigned to 16 wk of oral vitamin D3 (2000 IU/d; n = 499) or placebo (n = 167). Primary outcomes were changes in serum parathyroid hormone (PTH) and 1,25-dihydroxyvitamin D [1,25(OH)2D] concentrations from baseline to 16 wk.ResultsAmong 666 participants randomly assigned (mean age: 72 y; 53% female; 66% racial/ethnic minority), 611 (92%) completed the study. The mean (SD) change in PTH was -3 (16) pg/mL with vitamin D3 compared with 2 (18) pg/mL with placebo (estimated mean difference: -5; 95% CI: -8, -2 pg/mL). Within the vitamin D3 group, lower baseline 25-hydroxyvitamin D [25(OH)D] was associated with a larger decline in PTH in a nonlinear fashion. With baseline 25(OH)D ≥30 ng/mL as the reference, 25(OH)D <20 ng/mL was associated with a larger decline in PTH with vitamin D3 supplementation (-10; 95% CI: -15, -6 pg/mL), whereas 25(OH)D of 20-30 ng/mL was not (-2; 95% CI: -6, 1 pg/mL). A segmented threshold model identified a baseline 25(OH)D concentration of 21 (95% CI: 13, 31) ng/mL as an inflection point for difference in change in PTH. Race/ethnicity, BMI, and eGFR did not modify vitamin D treatment response. There was no significant change in 1,25(OH)2D in either treatment group.ConclusionsOf characteristics most commonly associated with vitamin D metabolism, only baseline 25(OH)D <20 ng/mL modified the PTH response to vitamin D supplementation, providing support from a clinical trial to use this threshold to define insufficiency. This trial was registered at clinicaltrials.gov as NCT02925195.

Project description:INTRODUCTION: The prevalence of metabolic syndrome is increasing disproportionately among the different ethnicities in Asia compared to the rest of the world. This study aims to determine the differences in the prevalence of metabolic syndrome across ethnicities in Malaysia, a multi-ethnic country. METHODS: In 2004, we conducted a national cross-sectional population-based study using a stratified two-stage cluster sampling design (N?=?17,211). Metabolic syndrome was defined according to the International Diabetes Federation/National Heart, Lung and Blood Institute/American Heart Association (IDF/NHLBI/AHA-2009) criteria. Multivariate models were used to study the independent association between ethnicity and the prevalence of the metabolic syndrome. RESULTS: The overall mean age was 36.9 years, and 50.0% participants were female. The ethnic distribution was 57.0% Malay, 28.5% Chinese, 8.9% Indian and 5.0% Indigenous Sarawakians. The overall prevalence of the metabolic syndrome was 27.5%, with a prevalence of central obesity, raised triglycerides, low high density lipoprotein cholesterol, raised blood pressure and raised fasting glucose of 36.9%, 29.3%, 37.2%, 38.0% and 29.1%, respectively. Among those <40 years, the adjusted prevalence ratios for metabolic syndrome for ethnic Chinese, Indians, and Indigenous Sarawakians compared to ethnic Malay were 0.81 (95% CI 0.67 to 0.96), 1.42 (95% CI 1.19 to 1.69) and 1.37 (95% CI 1.08 to 1.73), respectively. Among those aged ?40 years, the corresponding prevalence ratios were 0.86 (95% CI 0.79 to 0.92), 1.25 (95% CI 1.15 to 1.36), and 0.94 (95% CI 0.80, 1.11). The P-value for the interaction of ethnicity by age was 0.001. CONCLUSIONS: The overall prevalence of metabolic syndrome in Malaysia was high, with marked differences across ethnicities. Ethnic Chinese had the lowest prevalence of metabolic syndrome, while ethnic Indians had the highest. Indigenous Sarawakians showed a marked increase in metabolic syndrome at young ages.

Project description:IntroductionImplant stability is influenced by bone density, implant design, and site preparation characteristics. Piezoelectric implant site preparation (PISP) has been demonstrated to improve secondary stability compared with conventional drilling techniques. Osseodensification drills (OD) have been recently introduced to enhance both bone density and implant secondary stability. The objective of the present multi-center prospective randomized controlled trial was to monitor implant stability changes over the first 90 days of healing after implant bed preparation with OD or PISP.MethodsEach patient received two identical, adjacent or contralateral implants in the posterior maxilla. Following randomization, test sites were prepared with OD and control sites with PISP. Resonance frequency analysis was performed immediately after implant placement and after 7, 14, 21, 28, 60, and 90 days. Implants were then restored with single screw-retained metal-ceramic crowns and followed for 12 months after loading.ResultsTwenty-seven patients (15 males and 12 females; mean age 63.0 ± 11.8 years) were included in final analysis. Each patient received two identical implants in the posterior maxilla (total = 54 implants). After 1 year of loading, 53 implants were satisfactorily in function (one failure in test group 28 days after placement). Mean peak insertion torque (40.7 ± 12.3 Ncm and 39.5 ± 10.2 Ncm in test and control group, respectively) and mean implant stability quotient (ISQ) value at baseline (71.3 ± 6.9 and 69.3 ± 7.6 in test and control group, respectively) showed no significant differences between the two groups. After an initial slight stability decrease, a shift to increasing ISQ values occurred after 14 days in control group and after 21 days in test group, but with no significant differences in ISQ values between the two groups during the first 90 days of healing.ConclusionNo significant differences in either primary or secondary stability or implant survival rate after 1 year of loading were demonstrated between implants inserted into sites prepared with OD and PISP.

Dataset Information

Ethnic differences in antidepressant response: a prospective multi-site clinical trial.

Publications

Ethnic differences in antidepressant response: a prospective multi-site clinical trial.

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