title: Placebo-controlled trial of lithium augmentation of fluoxetine and lofepramine.
abstract: BACKGROUND
  This study was designed to establish whether (as suggested in a number of open and relatively small controlled trials) lithium augmentation is more effective than continued antidepressant alone, where response to a standard course of antidepressant treatment has been absent or partial.
  
  
  METHODS
  Lithium or placebo was added on a double-blind basis for six weeks to the drug regime of 62 patients with major depressive illness (in both hospital and primary care settings) who had failed to respond to a controlled trial of fluoxetine or lofepramine. Response was defined as a final Hamilton Depression Rating Scale (HDRS) score of < 10.
  
  
  RESULTS
  Response was seen more frequently in patients taking lithium (15/29) than in those remaining on antidepressant alone (8/32; P < 0.05). Rapid response to lithium augmentation (LA) was not consistently observed in this cohort. Mean HDRS scores after six weeks were significantly lower (P < 0.01) in the lithium group after excluding those who had not achieved significant exposure to lithium (arbitrarily defined as two or more lithium levels > or = 0.4 mmol/l). No differences in the efficacy of LA were apparent between fluoxetine and lofepramine.
  
  
  CONCLUSIONS
  Our results confirm that LA is a useful strategy in the treatment of antidepressant-resistant depression. Partial response was, however, frequently observed with continued antidepressant treatment alone, and the superiority of LA appears to depend on achieving adequate serum lithium levels.
authors.affiliation: Department of Psychiatry, University College London Medical School.
authors.forename: C L
authors.initials: CL
authors.lastname: Katona
authors.forename: M T
authors.initials: MT
authors.lastname: Abou-Saleh
authors.forename: D A
authors.initials: DA
authors.lastname: Harrison
authors.forename: B A
authors.initials: BA
authors.lastname: Nairac
authors.forename: D R
authors.initials: DR
authors.lastname: Edwards
authors.forename: T
authors.initials: T
authors.lastname: Lock
authors.forename: R A
authors.initials: RA
authors.lastname: Burns
authors.forename: M M
authors.initials: MM
authors.lastname: Robertson
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003866:Depressive Disorder / Q000097:blood / Q000188:drug therapy* / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005473:Fluoxetine / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D006801:Humans; D016651:Lithium Carbonate / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D008127:Lofepramine / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D008297:Male; D008875:Middle Aged
chemical_list: D005473:Fluoxetine; D016651:Lithium Carbonate; D008127:Lofepramine