A 24-week, randomized, controlled trial of adjunctive sibutramine versus topiramate in the treatment of weight gain in overweight or obese patients with bipolar disorders

Susan L. McElroy*, Mark A. Frye, Lori L. Altshuler, Trisha Suppes, Gerhard Hellemann, David Black, Jim Mintz, Ralph Kupka, Willem Nolen, Gabriele S. Leverich, Kirk D. Denicoff, Robert M. Post, Paul E. Keck

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

49 Citations (Scopus)

Abstract

Objectives: Patients with bipolar disorder (BD) have an increased risk of obesity as well as psychotropic-associated weight gain. The objective of this study was to compare sibutramine and topiramate as adjunctive treatments for psychotropic-associated weight gain in overweight or obese outpatients with BD.

Methods: In this 24-week, open-label, flexible-dose, comparison trial, 46 outpatients with bipolar disorders who had a body mass index (BMI) >= 30 kg/m(2), or >= 27 kg/m(2) with obesity-related comorbidities, and psychotropic-associated weight gain were randomly assigned to receive sibutramine (n = 18; 5-15 mg/day) or topiramate (n = 28; 25-600 mg/day). The primary outcome measure was weight loss. Secondary measures included changes in BMI, percent body weight loss, and mood symptoms.

Results: Patients randomized either to sibutramine or topiramate lost comparable amounts of weight (4.1 +/- 5.7 and 2.8 +/- 3.5 kg, respectively) and displayed similar rates of weight loss (0.85 and 0.82 kg/week, respectively). However, only four (22%) patients receiving sibutramine and six (21%) patients receiving topiramate completed the 24-week trial. In addition, the attrition patterns for the two drugs were different, with patients discontinuing topiramate doing so early in treatment and patients discontinuing sibutramine doing so throughout treatment. Also, higher ratings of manic and depressive symptoms significantly increased risk for early topiramate discontinuation compared to that for sibutramine.

Conclusons: Adjunctive sibutramine and topiramate may have comparable weight loss effects in overweight or obese bipolar patients with psychotropic-associated weight gain, but are each associated with similarly high discontinuation rates. In addition, they may have different attrition profiles. Compared to sibutramine, discontinuation of topiramate may be more likely to occur early in treatment and may be more dependent upon manic and depressive symptoms.

Original languageEnglish
Pages (from-to)426-434
Number of pages9
JournalBipolar Disorders
Volume9
Issue number4
Publication statusPublished - Jun-2007
Event6th International Conference on Bipolar Disorder - , Panama
Duration: 16-Jun-200518-Jun-2005

Keywords

  • bipolar disorder
  • obesity
  • sibutramine
  • topiramate
  • weight gain
  • BINGE-EATING DISORDER
  • PLACEBO-CONTROLLED TRIAL
  • 1-YEAR FOLLOW-UP
  • OPEN-LABEL
  • DOUBLE-BLIND
  • I-DISORDER
  • PHARMACOLOGICAL-TREATMENT
  • MANIC EPISODE
  • MOOD
  • EFFICACY

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