Impact of alprazolam in allostatic load and neurocognition of patients with anxiety disorders and chronic stress (GEMA): observational study protocol

SORIA CA, REMEDI C ; NÚÑEZ DA; D' ALESSIO L; ROLDÁN EJA

BMJ open

BMJ group

Lugar: London; Año: 2015 vol. 5

2044-6055

Introduction: The allostatic load model explains theadditive effects of multiple biological processes thataccelerate pathophysiology related to stress,particularly in the central nervous system. Stressrelatedmental conditions such as anxiety disordersand neuroticism (a well-known stress vulnerabilityfactor), have been linked to disturbances ofhypothalamo?pituitary?adrenal with cognitiveimplications. Nevertheless, there are controversialresults in the literature and there is a need todetermine the impact of the psychopharmacologicaltreatment on allostatic load parameters and in cognitivefunctions. Gador study of Estres Modulation byAlprazolam, aims to determine the impact ofmedication on neurobiochemical variables related tochronic stress, metabolic syndrome, neurocognitionand quality of life in patients with anxiety, allostaticload and neuroticism.Methods/analysis: In this observational prospectivephase IV study, highly sympthomatic patients withanxiety disorders (six or more points in the Hamilton-Ascale), neuroticism (more than 18 points in the Neofive personality factor inventory (NEO-FFI) scale), anallostatic load (three positive clinical or biochemicalitems at Crimmins and Seeman criteria) will beincluded. Clinical variables of anxiety, neuroticism,allostatic load, neurobiochemical studies,neurocognition and quality of life will be determinedprior and periodically (1, 2, 4, 8, and 12 weeks) aftertreatment (on demand of alprazolam from 0.75 mg/dayto 3.0 mg/day). A sample of n=55/182 patients will beconsidered enough to detect variables higher than 25%(pretreatment vs post-treatment or significantcorrelations) with a 1-ß power of 0?80. t Test and/ornon-parametric test, and Pearson?s test for correlationanalysis will be determined.Ethics and dissemination: This study protocol wasapproved by an Independent Ethics Committee ofFEFyM (Foundation for Pharmacological Studies andDrugs, Buenos Aires) and by regulatory authorities ofArgentina (ANMAT, Dossier # 61 409?8 of 20 April2009), following the law of Habeas Data andpsychotherapeutic drug control.