Background
Weight gain has been associated with many second generation antipsychotics (SGAs).
A variety of theories have been put forward as to the etiology of SGA-associated weight
gain. Modafinil possesses pharmacologic effects that could influence the weight gain
associated with SGAs. The objective of this trial was to determine the effect of modafinil
on olanzapine-associated weight gain.
Methods
This study was a 3-week, randomized, double-blind, placebo-controlled trial. All subjects
received olanzapine titrated to 10 mg/day. Concurrently, subjects were randomized
to receive modafinil titrated to 200 mg/day or placebo. Weight and feeding lab assessments
were conducted at baseline and endpoint.
Results
Fifty subjects were enrolled in the study with 20 subjects per group completing the
trial. The primary outcome variable was change in the body mass index (BMI) over the
3 weeks of the trial. Increases in BMI were observed in both groups. However, analysis
of covariance, controlled for baseline BMI, revealed that the olanzapine/placebo group
had a greater increase in BMI at end point compared with the olanzapine/modafinil
group (.89 ± .59 vs. .47 ± .50 kg/m2, p < .05). When controlled for gender, the comparison showed a significant difference
between groups at week 1 but not at weeks 2 or 3.
Conclusions
The results of this trial should not be extrapolated to clinical practice at this
time. These data do serve to support further evaluation in a patient population to
determine if the weight modifying effect of modafinil can be demonstrated over a longer
period of time.
Key words
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Article info
Publication history
Published online: December 22, 2008
Accepted:
October 24,
2008
Received in revised form:
October 24,
2008
Received:
May 20,
2008
Identification
Copyright
© 2009 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.
