title: Residual sleep disturbance and risk of relapse during the continuation/maintenance phase treatment of major depressive disorder with the selective serotonin reuptake inhibitor fluoxetine.
abstract: BACKGROUND
  Relapse of major depressive disorder (MDD) is a common clinical problem. This study was designed to determine whether residual sleep disturbance (insomnia and hypersomnia) predict risk of relapse during the continuation and maintenance treatment of MDD.
  
  
  METHODS
  A total of 570 patients with MDD were treated with open-label, flexible dose fluoxetine (range 20 to 60 mg; mean dose = 45.8 mg/day; SD = 15.1) for 12 weeks. Under double blind conditions, 262 patients who achieved clinical response were randomly assigned to continue fluoxetine or to switch to placebo for 52 weeks or until relapse. Residual sleep disturbance during the baseline visit of the double-blind phase was assessed using items 4, 5, 6 (insomnia) and 22, 23, 24 (hypersomnia) of the Hamilton Depression Rating Scale (HDRS). Survival analysis was utilized to determine the effect of residual sleep disturbance on risk of relapse.
  
  
  RESULTS
  The severities of early (P > 0.05), middle (P > 0.05), late (P > 0.05), or total (P > 0.05) residual insomnia were not found to significantly predict risk of relapse during continuation and maintenance-phase treatment. Similarly, the severities of early bedtime (P > 0.05), oversleeping (P > 0.05), napping (P > 0.05), or total (P > 0.05) residual hypersomnia were not found to significantly predict risk of relapse during continuation and maintenance-phase treatment.
  
  
  CONCLUSIONS
  The present study did not identify the severity of residual sleep disturbance among fluoxetine responders to predict risk of MDD relapse. The size of our sample may have precluded us from identifying more modest effects of residual sleep disturbance on the risk of relapse in MDD patients. Future studies are needed to further explore the relationship between residual sleep disturbance and relapse in MDD.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT00427128.
authors.affiliation: Depression Clinical and Research Program, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. huaiyuy@stanford.edu
authors.forename: Huaiyu
authors.initials: H
authors.lastname: Yang
authors.forename: Lara
authors.initials: L
authors.lastname: Sinicropi-Yao
authors.forename: Sarah
authors.initials: S
authors.lastname: Chuzi
authors.forename: Soo Jeong
authors.initials: SJ
authors.lastname: Youn
authors.forename: Alisabet
authors.initials: A
authors.lastname: Clain
authors.forename: Lee
authors.initials: L
authors.lastname: Baer
authors.forename: Ying
authors.initials: Y
authors.lastname: Chen
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: McGrath
authors.forename: Maurizio
authors.initials: M
authors.lastname: Fava
authors.forename: George I
authors.initials: GI
authors.lastname: Papakostas