title: Impact of alprazolam in allostatic load and neurocognition of patients with anxiety disorders and chronic stress (GEMA): observational study protocol.
abstract: BACKGROUND
  The allostatic load model explains the additive effects of multiple biological processes that accelerate pathophysiology related to stress, particularly in the central nervous system. Stress-related mental conditions such as anxiety disorders and neuroticism (a well-known stress vulnerability factor), have been linked to disturbances of hypothalamo-pituitary-adrenal with cognitive implications. Nevertheless, there are controversial results in the literature and there is a need to determine the impact of the psychopharmacological treatment on allostatic load parameters and in cognitive functions. Gador study of Estres Modulation by Alprazolam, aims to determine the impact of medication on neurobiochemical variables related to chronic stress, metabolic syndrome, neurocognition and quality of life in patients with anxiety, allostatic load and neuroticism.
  
  
  METHODS
  In this observational prospective phase IV study, highly sympthomatic patients with anxiety disorders (six or more points in the Hamilton-A scale), neuroticism (more than 18 points in the Neo five personality factor inventory (NEO-FFI) scale), an allostatic load (three positive clinical or biochemical items at Crimmins and Seeman criteria) will be included. Clinical variables of anxiety, neuroticism, allostatic load, neurobiochemical studies, neurocognition and quality of life will be determined prior and periodically (1, 2, 4, 8, and 12 weeks) after treatment (on demand of alprazolam from 0.75 mg/day to 3.0 mg/day). A sample of n=55/182 patients will be considered enough to detect variables higher than 25% (pretreatment vs post-treatment or significant correlations) with a 1-ß power of 0-80. t Test and/or non-parametric test, and Pearson's test for correlation analysis will be determined.
  
  
  BACKGROUND
  This study protocol was approved by an Independent Ethics Committee of FEFyM (Foundation for Pharmacological Studies and Drugs, Buenos Aires) and by regulatory authorities of Argentina (ANMAT, Dossier # 61 409-8 of 20 April 2009), following the law of Habeas Data and psychotherapeutic drug control.
  
  
  BACKGROUND
  GEMA 20811.
authors.affiliation: Department of Córdoba, Institute of Biosciences Henri Laborit, Buenos Aires, Argentina.
authors.forename: Carlos A
authors.initials: CA
authors.lastname: Soria
authors.affiliation: Department of Córdoba, Institute of Biosciences Henri Laborit, Buenos Aires, Argentina.
authors.forename: Carolina
authors.initials: C
authors.lastname: Remedi
authors.affiliation: Department of Scientific Direction, Gador SA, Buenos Aires, Argentina.
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Núñez
authors.affiliation: Department of Córdoba, Institute of Biosciences Henri Laborit, Buenos Aires, Argentina.
authors.forename: Luciana
authors.initials: L
authors.lastname: D'Alessio
authors.affiliation: Department of Scientific Direction, Gador SA, Buenos Aires, Argentina.
authors.forename: Emilio J A
authors.initials: EJ
authors.lastname: Roldán
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D055815:Young Adult; D052636:Allostasis; D000525:Alprazolam / Q000008:administration & dosage / Q000009:adverse effects; D014151:Anti-Anxiety Agents / Q000008:administration & dosage; D001008:Anxiety Disorders / Q000188:drug therapy; D001118:Argentina; D000075384:Neuroticism; D011446:Prospective Studies; D011788:Quality of Life; D013315:Stress, Psychological / Q000188:drug therapy; D064887:Observational Studies as Topic; D017327:Clinical Trials, Phase IV as Topic
chemical_list: D000525:Alprazolam; D014151:Anti-Anxiety Agents
keywords: CLINICAL PHARMACOLOGY