Fluoxetine: a randomized clinical trial in the maintenance of weight loss

Obes Res. 1993 Mar;1(2):92-8. doi: 10.1002/j.1550-8528.1993.tb00597.x.

Abstract

Because current weight-reduction treatments have considerable recidivism, a therapy that could help patients maintain weight loss would be of benefit. A six-center, randomized, double-blind trial compared the effects of the specific serotonin uptake inhibitor, fluoxetine hydrochloride, and placebo on maintenance of weight loss. Obese outpatients who had lost > or = 3.6 kg after 8 weeks of single-blind fluoxetine 60 mg/day in the qualification phase (N=317 [70.4% of patients entered]; mean +/- standard deviation [SD] weight loss, 6.8 +/- 2.8 kg) were randomly assigned to fluoxetine 20 mg/day (N=104), fluoxetine 60 mg/day (N=106), or placebo (N=107) for 40 weeks (maintenance phase). Patients received minimal nutrition/dietary counseling. Qualification phase clinic visits were biweekly; maintenance phase visits were monthly for 4 months, then bimonthly for 6 months. Patients treated with fluoxetine 60 mg/day continued to lose weight for 8 additional weeks (16 weeks total; maximum mean +/- SD weight loss, 7.2 +/- 4.6 kg); those treated with fluoxetine 20 mg/day or placebo began to regain weight. Mean weights remained below baseline values at week 48 (all groups); treatment differences were not statistically significant. Study completion rates were comparable (fluoxetine 20 mg/day, 67.3%; fluoxetine 60 mg/day, 56.6%; placebo, 67.3%; p = 0.175). Among commonly reported adverse events (> 10% incidence), only asthenia was reported statistically significantly (p < 0.050) more frequently with fluoxetine than with placebo. Few patients discontinued for any single adverse event. Fluoxetine 60 mg/day was effective for a longer period than fluoxetine 20 mg/day or placebo in maintaining weight loss. Overall, fluoxetine was safe and well tolerated.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Body Mass Index
  • Body Weight / drug effects*
  • Carbohydrates
  • Cholesterol / metabolism
  • Cholesterol, LDL / metabolism
  • Creatinine / metabolism
  • Double-Blind Method
  • Erythrocytes / metabolism
  • Female
  • Fluoxetine / adverse effects
  • Fluoxetine / therapeutic use*
  • Humans
  • Lymphocytes / metabolism
  • Male
  • Middle Aged
  • Models, Statistical
  • Obesity / drug therapy*
  • Placebos
  • Risk
  • Serotonin Uptake Inhibitors / therapeutic use*
  • Single-Blind Method
  • Time Factors
  • Treatment Outcome
  • Weight Gain
  • Weight Loss / drug effects*

Substances

  • Carbohydrates
  • Cholesterol, LDL
  • Placebos
  • Serotonin Uptake Inhibitors
  • Fluoxetine
  • Cholesterol
  • Creatinine