Connecting Public Health Students to Rural and Underserved Areas: Promoting Health Equity Through Field Placement Experiences.

There is an increasing demand for public health workers due to the unmet needs of the poor and underserved populations. However, through field placement experiences, students can actively engage in their own learning while also addressing critical needs of rural and medically underserved populations. In this mixed-methods evaluation, we explored experiences of emerging public health practitioners who participated in the Region IV Public Health Training Center's Pathways to Practice Scholars program between 2014 and 2018. Based on student confidence level ratings and descriptions of field placement experiences, scholars participated in meaningful and enriching field placement experiences in rural areas or on behalf of medically underserved populations. Across all eight Council on Linkages Core Competency Domains, students recorded increased pre- to post-confidence scores, and for many, the field placement experience appeared to affirm their interest in addressing the needs of these communities in the future.

Insights into the Effects of Crack Abuse on the Human Metabolome Using a NMR Approach.

Approximately 255 million people consume illicit drugs every year, among which 18 million use cocaine. A portion of this drug is represented by crack, but it is difficult to estimate the number of users since most are marginalized. However, there are no recognized efficacious pharmacotherapies for crack-cocaine dependence. Inflammation and infection in cocaine users may be due to behavior adopted in conjunction with drug-related changes in the brain. To understand the metabolic changes associated with the drug abuse disorder and identify biomarkers, we performed a 1H NMR-based metabonomic analysis of 44 crack users' and 44 healthy volunteers' blood serum. The LDA model achieved 98% of accuracy. From the water suppressed 1H NMR spectra analyses, it was observed that the relative concentration of lactate was higher in the crack group, while long chain fatty acid acylated carnitines were decreased, which was associated with their nutritional behavior. Analyses of the aromatic region of CPMG 1H NMR spectra demonstrated histidine and tyrosine levels increased in the blood serum of crack users. The reduction of carnitine and acylcarnitines and the accumulation of histidine in the serum of the crack users suggest that histamine biosynthesis is compromised. The tyrosine level points to altered dopamine concentration.

Traditional Colonial-type cheese from the south of Brazil: A case to support the new Brazilian laws for artisanal cheese production from raw milk.

Artisanal Colonial-type cheese is made from raw milk and is the main cheese produced by rural families of the southern region of Brazil. The aim of this study was to investigate, identify problems, and propose solutions for the current situation of small family farms producing and informally selling artisanal Colonial-type cheese located in the western part of Santa Catarina State in Southern Brazil. A semistructured questionnaire was employed in 12 rural properties to analyze the mode of production. Physical-chemical and microbiological analyses of water, raw milk, and cheese were performed, and it was found that 92, 50, and 100% of the samples, respectively, were outside of the current Brazilian regulatory parameters. None of the cheesemakers involved in this study met the requirements, as established by law, for artisanal cheese production from raw milk. This study concluded that technical support and changes in public policy are needed to ensure the preservation of this artisanal cheese, considering the historical importance and cultural traditions of these local communities and the socioeconomic importance of cheesemaking to family farming. Furthermore, more research on the safety of the cheese produced from raw milk is needed as well as the development of specific microbiological standards for artisanal Brazilian cheeses. Public policies aimed at guaranteeing food safety that formalize the commercialization of these cheeses will increase food security in those communities that currently produce artisanal cheese informally.

Potential of pepper plant accessions for ornamental purposes using diallel analysis.

The genus Capsicum is cultivated in various parts of the world, with C. annuum showing high diversity and potential for ornamental purposes and genetic improvement. The aim of this work was to evaluate the combining ability and heterosis of seedling and plant traits in accessions of ornamental pepper and their hybrids. Seven accessions of C. annuum were handcrossed and twelve quantitative plant traits were evaluated. The data were subjected to analysis of variance, the Scott-Knott test and diallel analysis using Griffing's method I (fixed model). Heterosis and its components were also determined. Non-additive effects were found for seedling height, cotyledonous leaf length and width; stem diameter and chlorophyll b content. All other traits showed predominance of additive effects. Heterosis effects were found for some hybrids and UFPB134 x UFPB137, UFPB134 x UFPB390, UFPB134 x UFPB004 and UFPB099 x UFPB004 showed seedlings that are more vigorous.

Larvicidal activity of Ottonia anisum metabolites against Aedes aegypti: A potential natural alternative source for mosquito vector control in Brazil.

BACKGROUND & OBJECTIVES: Aedes aegypti mosquito is the principal vector of the viruses responsible for urban yellow fever, dengue, dengue haemorrhagic fever, as well as Zika and chikungunya in Brazil. The present study was aimed to investigate the insecticidal potential of the extract and fractions of Ottonia anisum, along with special metabolites isolated from it, as natural alternatives against larvae (L3) of Ae. aegypti, vector of potentially deadly tropical infections in Brazil. METHODS: The plant species O. anisum was collected in March 2015, at Xerιm area, in Rio de Janeiro City, Brazil. Crude extracts and the isolated pure compounds were screened for toxicity against Ae. aegypti larvae (L3). Bioassays were performed on 20 larvae (L3) of Ae. aegypti in triplicate. The samples were dissolved in a mixture of acetone and DMSO at final concentrations of 1-200 µg/ml. The toxicity of the solutions was evaluated towards the growth and development of Ae. aegypti larvae till emergence of adults. RESULTS: The crude hexane extract showed 100% larval mortality 24 h after treatment at a concentration of 200 µg/ml. The bioassays using 1-butyl-3,4-methylenedioxybenzene revealed 100% mortality among L3 larvae, 24 h afterthe treatment at a concentration of 30 µg/ml, the LC recorded was 1.6 µg/ml. At concentration of 10 µg/ml, the L3 larval mortality recorded was 92%. INTERPRETATION & CONCLUSION: The metabolite 1-butyl-3,4-methylenedioxybenzene showed potent toxicity against Ae. aegypti larvae. This arylbutanoid agent could be used as a natural alternative adjuvant pesticide, in new compositions that would be environmentally safer.

Promoting Policy and Environmental Change in Faith-Based Organizations: Outcome Evaluation of a Mini-Grants Program.

High rates of heart disease, cancer, and stroke exist in rural South Georgia where the Emory Prevention Research Center's Cancer Prevention and Control Research Network provided mini-grant funding to six churches to implement policy and environmental change to promote healthy eating and physical activity. This study sought to determine whether perceptions of the health promotion environment changed over time and whether perceived environmental change was associated with healthy behavior at church and in general. This study used a single-group pre-post design with 1-year follow-up. Parishioners (N = 258) completed self-administered questionnaires assessing perceptions of the church health promotion environment relative to healthy eating and physical activity, eating behavior and intention to use physical activity facilities at church, and eating and physical activity behaviors generally. Results indicate that perceived improvements in church nutrition environments were most strongly associated with decreases in unhealthy food consumed and stronger intentions to use physical activity resources at church (ps ≤ .05). Perceived changes in the physical activity environment were unrelated to church or general behavior. Findings suggest that church environments may play an important role in supporting healthy eating and physical activity at church; however, whether the influence of the church environment extends to other settings is unknown.

Use of Mini-Grant to Disseminate Evidence-Based Interventions for Cancer Prevention and Control.

Mini-grants are an increasingly common tool for engaging communities in evidence-based interventions for promoting public health. This article describes efforts by 4 Centers for Disease Control and Prevention/National Cancer Institute-funded Cancer Prevention and Control Research Network centers to design and implement mini-grant programs to disseminate evidence-based interventions for cancer prevention and control. This article also describes source of evidence-based interventions, funding levels, selection criteria, time frame, number and size of grants, types of organizations funded, selected accomplishments, training and technical assistance, and evaluation topics/methods. Grant size ranged from $1000 to $10 000 (median = $6250). This mini-grant opportunity was characterized by its emphasis on training and technical assistance for evidence-based programming and dissemination of interventions from National Cancer Institute's Research-Tested Intervention Programs and Centers for Disease Control and Prevention's Guide to Community Preventive Services. All projects had an evaluation component, although they varied in scope. Mini-grant processes described can serve as a model for organizations such as state health departments working to bridge the gap between research and practice.

Staphylococcus aureus Isolated From Traditional Artisanal Raw Milk Cheese from Southern Brazil: Diversity, Virulence, and Antimicrobial Resistance Profile.

Staphylococcus aureus is one of the primary pathogenic agents found in cheeses produced with raw milk. Some strains of S. aureus are enterotoxigenic, possessing the ability to produce toxins responsible for staphylococcal food poisoning when present in contaminated foods. This study aimed to genotypically characterize, assess the antimicrobial resistance profile, and examine the enterotoxigenic potential of strains of S. aureus isolated from artisanal colonial cheese. Additionally, a bacterial diversity assessment in the cheeses was conducted by sequencing the 16S rRNA gene. The metataxomic profile revealed the presence of 68 distinct species in the cheese samples. Fifty-seven isolates of S. aureus were identified, with highlighted resistance to penicillin in 33% of the isolates, followed by clindamycin (28%), erythromycin (26%), and tetracycline (23%). The evaluated strains also exhibited inducible resistance to clindamycin, with nine isolates considered multidrug-resistant (MDR). The agr type I was the most prevalent (62%) among the isolates, followed by agr type II (24%). Additionally, ten spa types were identified. Although no enterotoxins and their associated genes were detected in the samples and isolates, respectively, the Panton-Valentine leukocidin gene (lukS-lukF) was found in 39% of the isolates. The presence of MDR pathogens in the artisanal raw milk cheese production chain underscores the need for quality management to prevent the contamination and dissemination of S. aureus strains.

Third-hand smoke as a potential intervention message for promoting smoke-free homes in low-income communities.

Third-hand smoke (THS) is the residual tobacco smoke contaminant that remains after a cigarette is extinguished. It can react with the indoor air pollutant nitrous acid to produce a carcinogen. Understanding perceptions of THS is critical, as it may inform the development of messages for promoting smoke-free homes. Six focus groups, of smokers and non-smokers, with 39 participants were conducted. Participants were asked whether they knew about THS and its harmful effects and whether it would motivate people to make their homes smoke free. They also answered questions about THS beliefs. Participants were mostly African-American, female and high-school graduate or General Educational Development (GED) recipients. Most of the participants had not heard about it and did not know what THS was. When asked about the dangers of THS, some participants made references to children indicating that they can easily inhale or ingest the residue leading to harmful effects. Almost all of the participants stated that they thought being educated about THS would motivate people to make their homes smoke free. There is a need for more scientific understanding of the potential dangers of THS and subsequent education about its exposure and harm to children and possibly adults.

Balancing fidelity and adaptation: implementing evidence-based chronic disease prevention programs.

OBJECTIVES: To describe adaptations that community-based organizations (CBOs) made to evidence-based chronic disease prevention intervention programs and to discuss reasons for those adaptations. DESIGN: The process evaluation used project report forms, interviews, and focus groups to obtain information from organizational staff. SETTING: Programs were conducted in community-based organizations (n = 12) in rural southwest Georgia including churches, worksites, community coalitions, a senior center, and a clinical patient setting. PARTICIPANTS: Site coordinators (n = 15), organizational leaders (n = 7), and project committee members (n = 25) involved in program implementation at 12 funded organizations. INTERVENTION: The Emory Cancer Prevention and Control Research Network awarded mini grants to rural CBOs to implement one of 5 evidence-based nutrition or physical activity programs. These sites received funding and technical assistance from Emory and agreed to conduct all required elements of the selected evidence-based program. MAIN OUTCOME MEASURES: Program implementation and context were explored, including completion of core elements, program adaptation, and reasons for adaptation that occurred at sites implementing evidence-based chronic disease prevention programs. RESULTS: Five major types of adaptations were observed: changing educational materials, intended audience, and program delivery; adding new activities; and deleting core elements. Sites had intentional or unintentional reasons for making program adaptations including enhancing engagement in the program, reaching specific audiences, increasing program fit, and reinforcing program messages. Reasons for not completing core elements (program deletions) included various types of "turbulence" or competing demands (eg, leadership/staff transitions and time constraints). CONCLUSIONS: The types of adaptations and reasons described in this evaluation support the idea that adaptation is a natural element of implementing evidence-based interventions. Building this understanding into dissemination strategies may help researchers and funders better reach communities with evidence-based interventions that are a relevant fit, while striving for fidelity.

Brazilian artisanal Colonial cheese: characterization, microbiological safety, and survival of Salmonella enterica serovar Enteritidis during ripening.

The artisanal Colonial cheese is typical of the southern region of Brazil and dates back to the colonization by Italian and German immigrants. Produced with raw milk, it is the main cheese produced by more than 15,200 small rural proprieties. The consumer increasingly appraises food with territorial valorization, demanding specific sanitary norms for this type of cheese. This work aimed to know the physical-chemical characteristics of the cheeses produced in the west of Santa Catarina State, to study the ripening time to reach microbiological safety, and to experimentally observe the survival of Salmonella enterica serovar Enteritidis ATCC 13076 during the ripening. The physical-chemical characterization was performed with 129 samples of cheeses. Five dairies were selected for evaluation of the ripening process. Salmonella survival using a challenge test was performed on three batches prepared in a pilot plant. The cheeses were classified as high (15.4%), medium (74.6%), and low moisture (9.2%), and concerning fat content as semi-fat (37.5%) and fat (62.5%). Salmonella challenge test demonstrated their survival for up to 28 days, depending on the initial contamination. The ripening monitoring showed that thermotolerant coliforms could be a good indicator of the process because they are the most persistent microorganisms.

Brain-derived neurotrophic factor serum levels following ketamine and esketamine intervention for treatment-resistant depression: secondary analysis from a randomized trial.

OBJECTIVES: Evidence suggests that ketamine's influence on brain-derived neurotrophic factor (BDNF) might be involved in its mechanism of rapid antidepressant action. We aimed to evaluate the differential impact of ketamine and esketamine on serum BDNF levels and its association with response patterns in treatment-resistant depression (TRD). METHODS: Participants (n = 53) are from a randomized, double-blind clinical trial comparing the efficacy of single-dose ketamine (0.5mg/kg, n = 27) and esketamine (0.25mg/kg, n = 26) in TRD. Depression severity was assessed before and 24 hours, 72 hours, and 7 days after the intervention, using the Montgomery-Åsberg Depression Rating Scale (MADRS). Blood samples were collected before infusion, 24 hours, and 7 days afterwards. RESULTS: There were no significant changes in BDNF levels at post-infusion evaluation points, and no difference in BDNF levels comparing ketamine and esketamine. Both drugs exhibited similar therapeutic effect. There was no association between BDNF levels and response to treatment or severity of depressive symptoms. CONCLUSION: There was no significant treatment impact on BDNF serum levels - neither with ketamine nor esketamine - despite therapeutic response. These results suggest that ketamine or esketamine intervention for TRD has no impact on BDNF levels measured at 24 hours and 7 days after the infusion.

Evaluation of the prevention programs that work curriculum to teach use of public health evidence to community practitioners.

Training on use of evidence may increase the adoption of evidence-based strategies in communities. The purpose of this study was to evaluate the Prevention Programs That Work training. This article summarizes the training modules and evaluation results from three trainings conducted in Spring 2009. The training teaches practitioners from community-based organizations to locate, choose, adopt or adapt, and evaluate an evidence-based program. Participants completed a pretest and posttest that covered competencies related to use of evidence, demographics, and feedback on training. A total of 47 participants attended three trainings. They represented coordinators, directors, nurses, and outreach workers. Participants showed the greatest increases in the following competencies: locate evidence-based resources, narrow search results of potential programs or strategies to reflect programmatic specifics, define steps in the adaptation process, and discuss factors during each phase of implementation. According to participants, the most useful aspects of the training content were the areas that covered program implementation, adaptation, and evaluation. A workshop can increase competencies to use evidence-based strategies among community practitioners. Building competencies is a critical initial step in promoting the dissemination of evidence-based strategies and helping practitioners use a systematic process to select an evidence-based intervention and implement the programs with fidelity.

Research to reality: a process evaluation of a mini-grants program to disseminate evidence-based nutrition programs to rural churches and worksites.

OBJECTIVES: To describe a project that used mini-grants plus technical assistance to disseminate evidence-based programs, to understand how the project worked in different settings, and to generate recommendations for future programming and evaluation. DESIGN: Process evaluation using program records, activity forms completed by grantees, interviews, and focus groups. SETTING: Churches and worksites in rural, southwest Georgia. PARTICIPANTS: Site coordinators (n = 10), organizational leaders (n = 7), and project committee members (n = 25) involved in program implementation at 7 funded organizations. INTERVENTION: The Emory Cancer Prevention and Control Research Network solicited applications from churches and worksites to implement one of 2 evidence-based nutrition programs: Body & Soul for churches and Treatwell 5-a-Day for worksites. Successful applicants (n = 7) received funding and technical assistance from Emory and agreed to conduct all required elements of the evidence-based program. MAIN OUTCOME MEASURES: We assessed adoption, reach, implementation, and maintenance of specific programs and their core elements, as well as contextual influences and the resources required to implement the mini-grants program. RESULTS: Four of the 7 funded organizations conducted all programmatic core elements; all 7 sites conducted at least 6 of 8 core elements, including at least 1 food-related policy or environmental change as a result of the program. Program reach varied widely across sites and core elements. All site coordinators stated that they intend to continue at least some of the activities conducted under the project. Sites reported that contextual factors such as the program's fit with the organization's mission, leadership support, and leadership or staffing transitions influenced program implementation. Over 18 months, Emory staff spent 47.7 hours providing technical assistance to grantees. CONCLUSIONS: A mini-grants and technical assistance model has the potential to be an effective mechanism for disseminating evidence-based programs to community organizations, and further study of this method is warranted.

Oligopeptidases activity in bipolar disorder: Ndel1 and angiotensin I converting enzyme.

BACKGROUND: Abnormal activity of two enzymes relevant to neurodevelopment, namely nuclear-distribution element-like 1 (Ndel1) and angiotensin I-converting enzyme (ACE), was reported in individuals with schizophrenia; to our knowledge, these oligopeptidases were never measured in bipolar disorder (BD). AIMS: Evaluate the enzyme activity of Ndel1 and ACE in euthymic individuals with BD type 1 which was compare to healthy control (HC) group. METHODS: Ndel1 and ACE activities were assessed in the serum of individuals with BD type 1 according to DSM-IV criteria (n = 70) and a HC group (n = 34). The possible differences between BD type 1 and HC groups were evaluated using Analysis of Covariance (ANCOVA), and the results were adjusted for age, gender and body mass index. RESULTS: We observed a positive correlation between Ndel1 activity and the total YMRS score in BD group (p = 0.030) and a positive correlation between ACE activity and Ham-D score (p = 0.047). ANCOVA analysis showed lower Ndel1 activity in BDs compared to HCs. Interestingly, we did not observe between-groups differences in ACE activity, despite the recognized correlation of ACE activity levels with cognitive functions, also described to be worsened in psychiatric patients. CONCLUSION: Oligopeptidases, especially Ndel1, which has been strongly correlated with neurodevelopment and brain formation, are potentially a good new target in the study of the neurobiology of BD. LIMITATIONS: The relatively small sample size did not permit to examine the cause-effect relationship of clinical dimensions of BD and the enzymatic activity.

[Monitoring of infant growth by health services in Pernambuco State, Brazil]. / Acompanhamento do crescimento em crianças menores de um ano: situação nos serviços de saúde em Pernambuco, Brasil.

A situational diagnosis was performed on infant growth monitoring in Greater Metropolitan Recife and in the interior of the State of Pernambuco, Brazil, using the database from the Survey on Maternal and Child Health in the State of Pernambuco, 1998, which included 816 infants (< 1 year of age) and 120 health units. Epi Info version 6.04 was used for the analysis. In the health services infrastructure, 15.8% of the health units lacked infant scales and the Child's Health Card, and 75.4% lacked the guidelines for monitoring growth and development. Of these variables, the first two showed a difference between the two study areas. As for process evaluation, 81.2% of the mothers had the Child's Health Card, 53.1% of the children had been weighed, and only 21% had been measured. Mothers had received insufficient orientation. These variables also showed differences between the two study areas. Care for children with nutritional risk received little attention in the two areas, although there was a difference between the interior and Metropolitan Recife. In conclusion, monitoring of infant growth has not been effectively consolidated in the State of Pernambuco.

FIRST POSTPARTUM HOME VISIT: A PROTECTIVE STRATEGY FOR EXCLUSIVE BREASTFEEDING. / PRIMEIRA VISITA DOMICILIAR PUERPERAL: UMA ESTRATÉGIA PROTETORA DO ALEITAMENTO MATERNO EXCLUSIVO.

OBJECTIVE: To investigate the influence of the first postpartum visit, family income, pacifier habit, number of siblings and birth weight on the maintenance of exclusive breastfeeding in infants aged one week up to six months. METHODS: In this cross-sectional study, data were collected through a survey, which included social and demographic characteristics of the families and the breastfeeding practice in children aged one week to six months, who received care at family health units in the municipality of Vitória de Santo Antão, Pernambuco, Northeast Brazil, between December 2014 and February 2015. Prevalence ratio was used to indicate how many times the outcome prevalence was increased by the influence of the studied variables, as well as a binary logistic regression model for the analysis and reliability of the results. RESULTS: The prevalence of exclusive breastfeeding was 41.7%. Family income, pacifier habit, number of siblings and birth weight did not show statistical association with the maintenance of exclusive breastfeeding. However, the absence of postpartum home visits adversely influenced the outcome (p=0.009). The children who received home visits had a higher chance of being exclusively breastfed for six months or more (PR 2.28, 95%CI 1.17-4.42). In the logistic regression, only the visit showed significance to estimate the probability of exclusive breastfeeding. CONCLUSIONS: The absence of postpartum home visits negatively influenced the duration of exclusive breastfeeding. This finding fills a gap in the knowledge of determinants of exclusive breastfeeding and may guide the planning of local strategies and actions to promote, protect and support exclusive breastfeeding.

OBJETIVO: Averiguar a influência da primeira visita puerperal, da renda familiar, do hábito de chupeta, do número de irmãos e do peso ao nascer na manutenção do aleitamento materno exclusivo (AME) em lactentes com uma semana de vida até seis meses de idade no município de Vitória de Santo Antão, Pernambuco. MÉTODOS: Neste estudo transversal, coletaram-se dados por inquérito que abrangiam características sociais e demográficas das famílias e prática de amamentação em crianças com uma semana até seis meses de vida, que compareceram às unidades de saúde da família de Vitória de Santo Antão nos dias de puericultura, entre dezembro de 2014 e fevereiro de 2015. Para indicar quantas vezes a prevalência do desfecho foi aumentada por influência dos fatores analisados, utilizou-se a Razão de Prevalência, bem como um modelo de regressão logística binária para análise e confiabilidade dos resultados. RESULTADOS: A prevalência de amamentação exclusiva foi de 41,7%. A renda familiar, o hábito de chupeta, o número de irmãos e o peso ao nascer não demonstraram significância estatística sobre a manutenção do AME. Em contrapartida, a ausência da visita puerperal (p=0,009) influenciou negativamente a sua permanência. As crianças que receberam visita mostraram maior possibilidade de estarem em AME (RP 2,28, IC95% 1,17-4,42). Na regressão logística apenas a visita apontou significância para estimar a probabilidade de ocorrer AME. CONCLUSÕES: A ausência da visita puerperal influenciou negativamente a manutenção do AME. Esse achado preenche a lacuna referente ao conhecimento dos fatores determinantes sobre essa prática e norteia o planejamento de ações e estratégias locais para promoção, proteção e apoio à amamentação exclusiva.

Social Environmental Correlates of Health Behaviors in a Faith-Based Policy and Environmental Change Intervention.

Diet and physical activity are behavioral risk factors for many chronic diseases, which are among the most common health conditions in the United States. Yet most Americans fall short of meeting established dietary and physical activity guidelines. Faith-based organizations as settings for health promotion interventions can affect members at multiple levels of the social ecological model. The present study investigated whether change in the church social environment was associated with healthier behavior at church and in general at 1-year follow-up. Six churches received mini-grants and technical assistance for 1 year to support policy and environmental changes for healthy eating (HE) and physical activity (PA). Socioenvironmental (social support and social norms) and behavioral (HE and PA at church and in general) outcomes were derived from baseline and 1-year follow-up church member surveys ( n = 258). Three of six churches demonstrated significant improvements in all three socioenvironmental aspects of HE. Two of five churches exhibited significant socioenvironmental improvements for PA at follow-up. Church social environmental changes were related to health behaviors at church and in general ( p < .05). Change in social support for HE, social support for PA, and social norms for PA were each associated with three church-based and general behavioral outcomes. Social norms for healthy eating were related to two general behavior outcomes and social norms for unhealthy eating to one general behavioral outcome. Study findings demonstrate that socioenvironmental characteristics are essential to multilevel interventions and merit consideration in designing policy and environmental change interventions.

Brain-derived neurotrophic factor serum levels following ketamine and esketamine intervention for treatment-resistant depression: secondary analysis from a randomized trial

Abstract Objectives Evidence suggests that ketamine's influence on brain-derived neurotrophic factor (BDNF) might be involved in its mechanism of rapid antidepressant action. We aimed to evaluate the differential impact of ketamine and esketamine on serum BDNF levels and its association with response patterns in treatment-resistant depression (TRD). Methods Participants (n = 53) are from a randomized, double-blind clinical trial comparing the efficacy of single-dose ketamine (0.5mg/kg, n = 27) and esketamine (0.25mg/kg, n = 26) in TRD. Depression severity was assessed before and 24 hours, 72 hours, and 7 days after the intervention, using the Montgomery-Åsberg Depression Rating Scale (MADRS). Blood samples were collected before infusion, 24 hours, and 7 days afterwards. Results There were no significant changes in BDNF levels at post-infusion evaluation points, and no difference in BDNF levels comparing ketamine and esketamine. Both drugs exhibited similar therapeutic effect. There was no association between BDNF levels and response to treatment or severity of depressive symptoms. Conclusion There was no significant treatment impact on BDNF serum levels - neither with ketamine nor esketamine - despite therapeutic response. These results suggest that ketamine or esketamine intervention for TRD has no impact on BDNF levels measured at 24 hours and 7 days after the infusion. This clinical trial is registered on the Japan Primary Registries Network: UMIN000032355.

Comparative study of esketamine and racemic ketamine in treatment-resistant depression: Protocol for a non-inferiority clinical trial.

INTRODUCTION: The use of ketamine as an option in the treatment of depressive disorder is growing rapidly, supported by numerous clinical trials attesting its efficacy and safety. Esketamine, the S (+) enantiomer of ketamine, is the most widely used form in the anesthetic environment in some countries, and new studies have shown that it may also be effective in depression and with better tolerability. However, no study so far has directly compared esketamine with racemic ketamine. Here we propose a protocol of a clinical trial to evaluate esketamine as a noninferior medication when compared to ketamine in the treatment of patients with treatment-resistant depression. METHODS/DESIGN: This study protocol is for a randomized, controlled, double-blind noninferiority clinical trial. Subjects will be 18 years or older, with major depression characterized as treatment-resistant. Participants will receive a single infusion of either esketamine (0.25 mg/kg) or ketamine (0.5 mg/kg) over 40 minutes. The primary outcome will be the difference in remission rates between the 2 treatment arms at 24 and 72 hours after drug infusion. Secondary outcomes will include other timepoints, measurements of cognition, dissociation, and blood biomarkers. DISCUSSION: A head-to-head study is the best way to evaluate whether the esketamine is in fact comparable to the racemic ketamine in terms of both efficacy and safety, and, if positive, it would be an initial step to increase the access to that type of treatment worldwide. ETHICS AND DISSEMINATION: The study was approved by the local Institutional Review Board (University Hospital Professor Edgard Santos-Federal University of Bahia-Number: 46657415.0.0000.0049). Subjects will only participate after voluntarily agreeing and signing the Informed Consent Form. The study findings will be published in peer-reviewed journals and presented at national and international conferences. TRIAL REGISTRATION: This trial has been registered in the Japan Primary Registries Network (JPRN): UMIN000032355, which is affiliated with the World Health Organization.