title: Duloxetine for major depressive disorder and daytime and nighttime hot flashes associated with the menopausal transition.
abstract: BACKGROUND
  We sought to obtain preliminary data regarding the efficacy of duloxetine for major depressive disorder (MDD) during the menopausal transition. The secondary outcomes were vasomotor symptoms (VMS, or hot flashes), specifically assessed as daytime or nighttime, and anxiety.
  
  
  METHODS
  After a single-blind placebo lead-in, peri- and postmenopausal women with MDD (n=19) received eight weeks of open-label treatment with duloxetine (60 mg/day). The Hamilton Rating Scale for Depression (17-item) (HAM-D) was the primary outcome measure. Hot flashes were monitored prospectively using daily diaries, the Greene Climacteric Scale (GCS), and the Hot Flash-Related Daily Interference Scale (HFRDIS). Anxiety was measured with the Generalized Anxiety Disorder scale (GAD-7).
  
  
  RESULTS
  Of 19 participants treated with duloxetine, 16 (84.2%) were evaluable (returned for ≥ 1 follow up), and 13 (68.4%) completed the study. Three discontinued due to side effects. The pre-treatment and final median HAM-D scores were 15 (interquartile range [IQR] 14-18), and 6.5 (IQR 4-11.5), respectively, reflecting a significant decrease (p=.0006). The response and remission rates were 56.3% (all responders were also remitters, having ≥ 50% decrease in HAM-D scores and final scores ≤ 7). Anxiety improved with treatment (p=.012). GCS and HFRDIS scores decreased significantly. Among those who reported hot flashes at baseline, number and severity of hot flashes improved significantly overall (p=.009 and p=.008, respectively). Daytime but not nighttime hot flashes improved significantly.
  
  
  CONCLUSIONS
  These data support further study of duloxetine for the treatment of a spectrum of symptoms associated with the menopausal transition.
authors.affiliation: Massachusetts General Hospital, Harvard Medical School, USA. mfreeman@partners.org
authors.forename: Marlene P
authors.initials: MP
authors.lastname: Freeman
authors.forename: April M
authors.initials: AM
authors.lastname: Hirschberg
authors.forename: Betty
authors.initials: B
authors.lastname: Wang
authors.forename: Laura F
authors.initials: LF
authors.lastname: Petrillo
authors.forename: Stephanie
authors.initials: S
authors.lastname: Connors
authors.forename: Susan
authors.initials: S
authors.lastname: Regan
authors.forename: Hadine
authors.initials: H
authors.lastname: Joffe
authors.forename: Lee S
authors.initials: LS
authors.lastname: Cohen
mesh_terms: D000928:Antidepressive Agents / Q000627:therapeutic use*; D001007:Anxiety / Q000188:drug therapy*; D001008:Anxiety Disorders / Q000188:drug therapy*; D003865:Major Depressive Disorder / Q000188:drug therapy*; D000068736:Duloxetine Hydrochloride; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D008593:Menopause; D008875:Middle Aged; D018579:Patient Selection; D012720:Severity of Illness Index; D013876:Thiophenes / Q000627:therapeutic use*
chemical_list: D000928:Antidepressive Agents; D013876:Thiophenes; D000068736:Duloxetine Hydrochloride