title: Impact of self-reported juvenile abuse on treatment outcome in patients with major depressive disorder.
abstract: BACKGROUND
  We assessed the impact of juvenile abuse (emotional, physical, or sexual) on response to treatment in adults with major depressive disorder (MDD) suboptimally responsive to antidepressant therapy.
  
  
  METHODS
  A post hoc analysis explored the relationship between self-reported history of juvenile abuse and response to risperidone or placebo augmentation during a 6-week double-blind study period in patients with MDD suboptimally responsive to a previous adequate trial of antidepressant monotherapy.
  
  
  RESULTS
  Overall, only one clinical measure showed a small, but statistically significant difference in outcome between patients with abuse versus without abuse (HRSD-17). In patients reporting abuse (n=141), improvement with risperidone versus placebo augmentation was greater on several measures: HRSD-17 total and 2 subscale scores, responder rates, Q-LES-Q, and PaRTS-D. In patients without abuse (n=127), only two measures showed significant improvement: HRSD-17 subscale and PaRTS-D. Responder rates (HRSD-17) were: 40.9% (risperidone) versus 23.1% (placebo; p=0.01; odds ratio=2.7) in those with abuse, and 41.0% versus 34.4% (p=0.39; odds ratio=1.4) in those without. Adverse events rates were: 37.0% (risperidone) and 54.4% (placebo) in patients with abuse, and 56.3% and 55.6% in those without.
  
  
  CONCLUSIONS
  Analysis not preplanned. Validated questionnaire not used to determine abuse status.
  
  
  CONCLUSIONS
  Self-reported juvenile abuse history may impact response to risperidone augmentation therapy in adults with MDD suboptimally responsive to antidepressants. Abuse status may reduce placebo response and reporting of adverse events.
authors.affiliation: Janssen Research & Development, LLC, Raritan, NJ 08560, USA. gpandina@its.jnj.com
authors.forename: Gahan
authors.initials: G
authors.lastname: Pandina
authors.forename: Ibrahim
authors.initials: I
authors.lastname: Turkoz
authors.forename: Cynthia
authors.initials: C
authors.lastname: Bossie
mesh_terms: D000293:Adolescent; D000328:Adult; D054523:Adult Survivors of Child Abuse / Q000523:psychology*; D000368:Aged; D000928:Antidepressive Agents / Q000627:therapeutic use; D003865:Major Depressive Disorder / Q000150:complications / Q000188:drug therapy / Q000523:psychology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D012189:Retrospective Studies; D018967:Risperidone / Q000627:therapeutic use; D057566:Self Report; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000928:Antidepressive Agents; D018967:Risperidone
keywords: Depression; Juvenile abuse; Placebo; Risperidone