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The Capital Region of Denmark - a part of Copenhagen University Hospital

Translation of randomised controlled trial findings into clinical practice: comparison of olanzapine and valproate in the EMBLEM study

Research output: Contribution to journalJournal articleResearchpeer-review


  • D Novick
  • A Gonzalez-Pinto
  • J M Haro
  • J Bertsch
  • C Reed
  • E Perrin
  • M Tohen
  • jens knud larsen
  • Jens Knud Larsen
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OBJECTIVES: The aim of this study was to compare the outcomes of olanzapine- and valproate-treated patients in an observational study of acute mania with the results of a randomised controlled trial (RCT) assessing the same treatments. METHODS: EMBLEM (European Mania in Bipolar Evaluation of Medication) was a 2-year, prospective, observational study of health outcomes associated with the treatment of mania. Severity of mania and depression were assessed at baseline and 6 weeks using the YMRS and the 5-item version of the HAMD, respectively. RESULTS: 621 patients were analysed (n=107 valproate, n=514 olanzapine). Both groups improved from baseline to 6 weeks in mean YMRS and HAMD-5 total scores, with greater mean improvements in the olanzapine compared with the valproate group. Olanzapine was associated with more weight gain and less gastrointestinal difficulties than valproate. DISCUSSION: The EMBLEM results support those of the RCT, which suggest that olanzapine monotherapy seems to be more effective than valproate monotherapy in the treatment of acute mania.
Original languageEnglish
Issue number4
Pages (from-to)145-52
Number of pages7
Publication statusPublished - 2009

Bibliographical note

Keywords: Adult; Antidepressive Agents; Antimanic Agents; Benzodiazepines; Bipolar Disorder; Female; Gastrointestinal Diseases; Humans; Male; Prospective Studies; Psychiatric Status Rating Scales; Randomized Controlled Trials as Topic; Treatment Outcome; Valproic Acid; Weight Gain

ID: 172970