ORIGINAL ARTICLESA 12-week, open, randomized trial comparing sodium valproate to lithium in patients with bipolar I disorder suffering from a manic episodeBowden, Charlesa; Göğüş, Ahmetb *; Grunze, Heinzc; Häggström, Larsd; Rybakowski, Janusze; Vieta, EduardfAuthor Information aDepartment of Psychiatry, University of Texas Health Science Center, San Antonio, Texas, USA bDepartment of Psychiatry, Hacettepe University, Ankara, Turkey cDepartment of Psychiatry, Ludwig-Maximilians University, Munich, Germany dDepartment of Psychiatry, Central Hospital, Halmstad, Sweden eDepartment of Adult Psychiatry, Poznañ University of Medical Sciences, Poznañ, Poland fBipolar Disorders Program, Hospital Clinic, University of Barcelona, IDIBAPS, Barcelona, Spain Correspondence to Dr Charles L. Bowden, MD, University of Texas Health Science Center, 7703 Floyd Curl Drive, Mail Code 7792, San Antonio, TX 78229-3900, USA Tel: +1 210 567 5405; fax: +1 210 567 3759; e-mail: [email protected] *Ahmet Göğüş: deceased. Received 12 October 2007 Accepted 18 February 2008 International Clinical Psychopharmacology: September 2008 - Volume 23 - Issue 5 - p 254-262 doi: 10.1097/YIC.0b013e3282fd827c Buy Metrics Abstract On the basis of 3-week studies, lithium and valproate are both recommended for first-line treatment of acute mania. It is, however, also important to demonstrate that antimanic efficacy can be maintained. This study has been designed to compare the efficacy and tolerability of valproate and lithium over 12 weeks in the treatment of acute mania in patients with type I bipolar disorder. Three hundred patients with bipolar I disorder presenting with acute mania were randomized to open treatment with lithium (starting dose: 400 mg/day) or valproate (starting dose: 20 mg/kg/day) for 12 weeks. The primary efficacy criterion was remission (YMRS score ≤12 at study end and a reduction of ≥2 on the CGI-BP severity scale). Remission rates were 65.5% (lithium group) and 72.3% (valproate group). Noninferiority of valproate with respect to lithium was demonstrated [between-group difference: 6.78% (95% confidence intervals: −3.80 to 17.36%)]. Remission rates assessed by the secondary mixed model repeated measures analysis were significantly greater with valproate than with lithium. Adverse events were reported in 44% of patients in both groups. Valproate and lithium showed comparable efficacy and tolerability in the treatment of acute mania over 12 weeks. © 2008 Lippincott Williams & Wilkins, Inc.