title: Inclusion/exclusion criteria in late life depression antidepressant efficacy trials.
abstract: The generalizability of antidepressant efficacy trials (AETs) has been questioned. No studies have examined the inclusion/exclusion criteria used in placebo-controlled studies of late life depression and compared them to the criteria used in non-late life AETs.
  
  
  
  We conducted a comprehensive literature review of placebo-controlled AETs published from January, 1995 through December, 2014. We compared the inclusion/exclusion criteria used in the 18 studies of late life depression to those used in non-late life depression.
  
  
  
  There were nine inclusion/exclusion criteria that were used in more than half of the late life depression AETs: minimum severity on a symptom severity scale (100.0%), significant suicidal ideation (77.8%), psychotic features during the current episode of depression or history of a psychotic disorder (94.4%), history of bipolar disorder (77.8%), diagnosis of alcohol or drug abuse or dependence (83.3%), presence of a comorbid nondepressive, nonsubstance use Axis I disorder (55.6%), episode duration too short (66.7%), and an insufficient score on a cognitive screen (88.3%) or the presence of a cognitive disorder (55.6%). There were some differences between the late life and non-late life depression studies-use of a screening measure of cognitive functioning, presence of a cognitive disorder such as dementia, and the minimum depression severity cutoff score required at baseline.
  
  
  
  The inclusion/exclusion criteria in AETs of late life depression were generally similar to the criteria used in non-late life depression AETs. Copyright © 2016 John Wiley & Sons, Ltd.
authors.affiliation: Department of Psychiatry and Human Behavior, Brown Medical School, Department of Psychiatry, Rhode Island Hospital, Providence, RI, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Zimmerman
authors.affiliation: Department of Psychiatry and Human Behavior, Brown Medical School, Department of Psychiatry, Rhode Island Hospital, Providence, RI, USA.
authors.forename: Matthew D
authors.initials: MD
authors.lastname: Multach
authors.affiliation: Department of Psychiatry and Human Behavior, Brown Medical School, Department of Psychiatry, Rhode Island Hospital, Providence, RI, USA.
authors.forename: Heather L
authors.initials: HL
authors.lastname: Clark
authors.affiliation: Department of Psychiatry and Human Behavior, Brown Medical School, Department of Psychiatry, Rhode Island Hospital, Providence, RI, USA.
authors.forename: Emily
authors.initials: E
authors.lastname: Walsh
authors.affiliation: Department of Psychiatry and Human Behavior, Brown Medical School, Department of Psychiatry, Rhode Island Hospital, Providence, RI, USA.
authors.forename: Lia K
authors.initials: LK
authors.lastname: Rosenstein
authors.affiliation: Department of Psychiatry and Human Behavior, Brown Medical School, Department of Psychiatry, Rhode Island Hospital, Providence, RI, USA.
authors.forename: Douglas
authors.initials: D
authors.lastname: Gazarian
mesh_terms: D000928:Antidepressive Agents / Q000627:therapeutic use*; D003866:Depressive Disorder / Q000188:drug therapy*; D005260:Female; D006801:Humans; D018579:Patient Selection; D011569:Psychiatric Status Rating Scales; D016032:Randomized Controlled Trials as Topic / Q000379:methods*
chemical_list: D000928:Antidepressive Agents
keywords: antidepressant efficacy trials; antidepressants; exclusion criteria; external validity; generalizability; late life depression