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1.
J Clin Psychopharmacol ; 36(6): 669-674, 2016 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-27755217

RESUMEN

Although the precise drug mechanism of action of acamprosate remains unclear, its antidipsotropic effect is mediated in part through glutamatergic neurotransmission. We evaluated the effect of 4 weeks of acamprosate treatment in a cohort of 13 subjects with alcohol dependence (confirmed by a structured interview, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) on proton magnetic resonance spectroscopy glutamate levels in the midline anterior cingulate cortex (MACC). We compared levels of metabolites with a group of 16 healthy controls. The Pennsylvania Alcohol Craving Scale was used to assess craving intensity. At baseline, before treatment, the mean cerebrospinal fluid-corrected MACC glutamate (Glu) level was significantly elevated in subjects with alcohol dependence compared with controls (P = 0.004). Four weeks of acamprosate treatment reduced glutamate levels (P = 0.025), an effect that was not observed in subjects who did not take acamprosate. At baseline, there was a significant positive correlation between cravings, measured by the Pennsylvania Alcohol Craving Scale, and MACC (Glu) levels (P = 0.019). Overall, these data would suggest a normalizing effect of acamprosate on a hyperglutamatergic state observed in recently withdrawn patients with alcohol dependence and a positive association between MACC glutamate levels and craving intensity in early abstinence. Further research is needed to evaluate the use of these findings for clinical practice, including monitoring of craving intensity and individualized selection of treatment with antidipsotropic medications in subjects with alcohol dependence.


Asunto(s)
Disuasivos de Alcohol/farmacología , Alcoholismo/tratamiento farmacológico , Ácido Glutámico/metabolismo , Giro del Cíngulo/metabolismo , Taurina/análogos & derivados , Acamprosato , Adulto , Disuasivos de Alcohol/administración & dosificación , Alcoholismo/metabolismo , Femenino , Ácido Glutámico/efectos de los fármacos , Giro del Cíngulo/efectos de los fármacos , Humanos , Masculino , Persona de Mediana Edad , Espectroscopía de Protones por Resonancia Magnética , Taurina/administración & dosificación , Taurina/farmacología , Resultado del Tratamiento , Adulto Joven
2.
Alcohol Clin Exp Res ; 40(8): 1609-16, 2016 08.
Artículo en Inglés | MEDLINE | ID: mdl-27439218

RESUMEN

BACKGROUND: Quantifying craving longitudinally during the course of withdrawal, early abstinence, and relapse is essential for optimal management of alcohol use disorder (AUD). In an effort to identify biological correlates of craving, we used proton magnetic resonance spectroscopy (1H-MRS) to investigate the correlation between craving and glutamate levels in the left dorsolateral prefrontal cortex (LDLPFC) of patients with AUD. METHODS: Participants underwent 1H-MRS of the LDLPFC with 2-dimensional J-resolved (2DJ) averaged PRESS. MRS data were processed with LCModel and cerebrospinal fluid (CSF)-corrected to generate metabolite concentrations. The Penn Alcohol Craving Scale (PACS) and the 30-day time line follow-back (TLFB 30) were used to quantify craving for alcohol and drinking patterns, respectively. RESULTS: There was a statistically significant positive correlation between CSF-corrected glutamate ([Glu]) levels and PACS scores (n = 14; p = 0.005). When PACS scores were dichotomized (< or ≥median = 16), [Glu] levels were significantly higher in the high- versus low-craving group (p = 0.007). In addition, there was a significant negative correlation between CSF-corrected N-acetyl aspartic acid ([NAA]) levels and mean number of drinks per drinking day in the past month (n = 13; TLFB 30; p = 0.012). When mean TLFB 30 was dichotomized (< or ≥median = 7.86), [NAA] levels were significantly lower in subjects that consumed more alcoholic beverages. There was no significant correlation between [Glu] and [NAA] levels with other measures of drinking behavior and or depression symptom severity. CONCLUSIONS: While limited by small sample size, these data suggest that glutamate levels in LDLPFC are associated with alcohol craving intensity in patients with AUD. Further study with larger sample size is needed to replicate this finding and evaluate the merits of glutamate spectroscopy as a biological correlate of alcohol craving intensity and a guide to treatment interventions.


Asunto(s)
Consumo de Bebidas Alcohólicas/metabolismo , Trastornos Relacionados con Alcohol/metabolismo , Ansia/fisiología , Ácido Glutámico/metabolismo , Corteza Prefrontal/metabolismo , Adulto , Abstinencia de Alcohol/tendencias , Trastornos Relacionados con Alcohol/diagnóstico por imagen , Trastornos Relacionados con Alcohol/terapia , Femenino , Humanos , Estudios Longitudinales , Espectroscopía de Resonancia Magnética/métodos , Masculino , Persona de Mediana Edad , Corteza Prefrontal/diagnóstico por imagen , Centros de Tratamiento de Abuso de Sustancias/tendencias
3.
Vaccine ; 40(25): 3466-3469, 2022 05 31.
Artículo en Inglés | MEDLINE | ID: mdl-35534313

RESUMEN

BACKGROUND: More than 130 million individuals in the United States have now received at least one dose of a COVID-19 vaccine. Currently, all adults in the Unites States now have access to one of three COVID-19 vaccines. As part of the vaccination procedure, Emergency Use Authorization (EUA) fact sheets, which contain information regarding the vaccine, are provided. The purpose of this study was to analyze the ease of reading (i.e., readability) of the EUA-approved fact sheets for the vaccines currently available in the United States, the V-Safe adverse event survey script, and the Centers for Disease Control and Prevention (CDC) website information on COVID-19 vaccines designed for the general public in the United States. METHODS: We acquired the Pfizer, Moderna, and Janssen EUA fact sheets, as well as the V-Safe survey script and the CDC website information regarding COVID-19 vaccines. These documents were analyzed for their complexity regarding the following readability factors: average length of paragraphs, sentences, and words; font size and style; use of passive voice; the Gunning-Fog index; the Flesch Reading Ease index; and the Flesch-Kincaid Grade Level index. RESULTS: Only the V-Safe adverse-event survey script met readability standards for adequate comprehension. The mean readability scores of the EUA fact sheets and the CDC website were as follows: Flesch Reading Ease score (44.35 avg); Flesch-Kincaid Grade Level (10.48 avg); and Gunning-Fog index (11.8 avg).These scores indicate that at least a 10th-grade level education would be required to understand these reading materials. CONCLUSION: The average person in the United States would have difficulty understanding the information provided in the EUA fact sheets and CDC COVID-19 vaccine website documents; however, the V-Safe survey was written at an adequate reading level. To ensure that the general public fully understands information regarding COVID-19 vaccines, greater care and effort should be given to the development of simplified information material.


Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , Comprensión , Información de Salud al Consumidor , COVID-19/prevención & control , Humanos , Internet , Lenguaje , Encuestas y Cuestionarios , Estados Unidos
4.
Mayo Clin Proc ; 96(8): 2095-2101, 2021 08.
Artículo en Inglés | MEDLINE | ID: mdl-34226027

RESUMEN

OBJECTIVE: To assess the readability of the informed consent forms from the phase 3 COVID-19 vaccine trials conducted in the United States. PATIENTS AND METHODS: English consent forms were used for patients in phase 3 COVID-19 vaccine clinical trials. Consent forms were obtained in October 2020. Using Microsoft Word tools, we analyzed the readability (ie, the ease of reading) of written consent forms and informational documents from phase 3 COVID-19 vaccine clinical trials in the United States from the following manufacturers: AstraZeneca, Moderna, Pfizer, Johnson & Johnson, and Novavax. RESULTS: Owing to low readability and several format factors, this study determined that none of the consent forms or informational documents from the recent phase 3 COVID-19 vaccine clinical trials conducted in the United States met readability standards at the recommended 7th grade readability level for the average vaccine research volunteer in any readability category. The average English-speaking vaccine trial volunteer would have great difficulty comprehending the information provided in the consent forms and informational documents. To ensure that study subjects receive and fully comprehend information regarding a clinical study and can provide reliable consent, greater attention should be given to the development and use of simplified consent forms, multimedia formatting, personal discussion, and comprehension assessments.


Asunto(s)
Vacunas contra la COVID-19 , Comprensión , Información de Salud al Consumidor , Alfabetización en Salud , Consentimiento Informado , Ensayos Clínicos Fase III como Asunto , Humanos , Estados Unidos
5.
J Affect Disord ; 172: 355-60, 2015 Feb 01.
Artículo en Inglés | MEDLINE | ID: mdl-25451437

RESUMEN

BACKGROUND: There are no self-report scales that assess manic/hypomanic symptoms in patients with depression. The aim of this study was to explore the use of a modified screening instrument for bipolar disorder to assess current manic/hypomanic symptoms in patients with a depressive episode. METHODS: The study sample consisted of 188 patients with Structured Clinical Interview for DSM-IV-TR disorders (SCID) confirmed bipolar or major depressive disorder. We modified the Hypomania Checklist-32 (mHCL-32) to assess current instead of lifetime symptoms. An Exploratory Factor Analysis (EFA) was conducted to identify clusters of mHCL-32 items that were endorsed concurrently. A Latent Class Analysis (LCA) was carried out to identify groups of patients with similar mHCL-32 item endorsement patterns. RESULTS: The EFA identified 3 factors: factor #1 ("elation-disinhibition-increased goal directed activity"), factor #2 ("risk-taking-impulsivity-substance use") and factor #3 (distractibility-irritability). The LCA yielded 3 classes (2 showing manic/hypomanic features). While class #1 patients endorsed more items related to disinhibition and racing thoughts, class #2 patients recognized more items associated with irritability and substance use. LIMITATIONS: Lack of an adequate gold standard measure of mixed depression to compare to, the cross-sectional design and the lack of a validation sample. CONCLUSIONS: The mHCL-32 scale allowed a comprehensive and convergent delineation of hypomanic/manic symptoms in depression. Further validation of these findings is needed.


Asunto(s)
Trastorno Bipolar/diagnóstico , Trastorno Ciclotímico/diagnóstico , Depresión/diagnóstico , Trastorno Depresivo Mayor/diagnóstico , Entrevista Psicológica/normas , Adulto , Lista de Verificación/normas , Estudios Transversales , Diagnóstico Diferencial , Manual Diagnóstico y Estadístico de los Trastornos Mentales , Análisis Factorial , Femenino , Humanos , Masculino , Persona de Mediana Edad , Proyectos Piloto , Agitación Psicomotora/diagnóstico , Factores de Riesgo
6.
J Affect Disord ; 152-154: 478-82, 2014 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-24070907

RESUMEN

BACKGROUND: Mixed depression is a common, dimensional phenomenon that is increasingly recognized in unipolar and bipolar disorders. We piloted a modified version of the Hypomania Checklist (mHCL-32) to assess the prevalence and clinical correlates of concurrent manic (hypo) symptoms in depressed patients. METHODS: The mHCL-32, Young Mania Rating Scale (YMRS) and Hamilton Rating Scale for Depression (HAMD-24) were utilized in the assessment of unipolar (UP=61) and bipolar (BP=44) patients with an index major depressive episode confirmed by the Structured Clinical Interview for DSM-IV (SCID). Differential mHLC-32 item endorsement was compared between UP and BP. Correlation analyses assessed the association of symptom dimensions measured by mHCL-32, YMRS and HAMD-24. RESULTS: There was no significant difference between mood groups in the mean mHCL-32 and YMRS scores. Individual mHLC-32 items of increased libido, quarrels, and caffeine intake were endorsed more in BP vs. UP patients. The mHCL-32 active-elevated subscale score was positively correlated with the YMRS in BP patients and negatively correlated with HAMD-24 in UP patients. Conversely, the mHCL-32 irritable-risk taking subscale score was positively correlated with HAMD-24 in BP and with YMRS in UP patients. LIMITATIONS: Small sample size and cross-sectional design. CONCLUSION: Modifying the HCL to screen for (hypo) manic symptoms in major depression may have utility in identifying mixed symptoms in both bipolar vs. unipolar depression. Further research is encouraged to quantify mixed symptoms with standardized assessments.


Asunto(s)
Trastorno Bipolar/diagnóstico , Trastorno Depresivo Mayor/psicología , Adulto , Trastorno Bipolar/epidemiología , Trastorno Bipolar/psicología , Lista de Verificación/métodos , Lista de Verificación/normas , Estudios Transversales , Trastorno Depresivo/diagnóstico , Trastorno Depresivo/psicología , Trastorno Depresivo Mayor/diagnóstico , Femenino , Humanos , Cooperación Internacional , Entrevista Psicológica , Masculino , Proyectos Piloto , Prevalencia , Escalas de Valoración Psiquiátrica
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