Fluoxetine: A Randomized Clinical Trial in the Maintenance of Weight Loss
Article first published online: 6 SEP 2012
1993 North American Association for the Study of Obesity (NAASO)
Volume 1, Issue 2, pages 92–98, March 1993
How to Cite
Goldstein, D. J., Rampey, A. H., Dornseif, B. E., Levine, L. R., Potvin, J. H. and Fludzinski, L. A. (1993), Fluoxetine: A Randomized Clinical Trial in the Maintenance of Weight Loss. Obesity Research, 1: 92–98. doi: 10.1002/j.1550-8528.1993.tb00597.x
- Issue published online: 6 SEP 2012
- Article first published online: 6 SEP 2012
- Accepted for publication in final form Oct. 22,1992.
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 ≤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.