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An exploration of the effect of modafinil on olanzapine associated weight gain in normal human subjects.
Biol Psychiatry. 2009 Apr 01; 65(7):607-13.BP

Abstract

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/m(2), 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.

Authors+Show Affiliations

University of North Dakota School of Medicine and Health Sciences, 120 South 8th Street, Fargo, ND 58107-1415, USA. jroerig@nrifargo.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19103435

Citation

Roerig, James L., et al. "An Exploration of the Effect of Modafinil On Olanzapine Associated Weight Gain in Normal Human Subjects." Biological Psychiatry, vol. 65, no. 7, 2009, pp. 607-13.
Roerig JL, Steffen KJ, Mitchell JE, et al. An exploration of the effect of modafinil on olanzapine associated weight gain in normal human subjects. Biol Psychiatry. 2009;65(7):607-13.
Roerig, J. L., Steffen, K. J., Mitchell, J. E., Crosby, R. D., & Gosnell, B. A. (2009). An exploration of the effect of modafinil on olanzapine associated weight gain in normal human subjects. Biological Psychiatry, 65(7), 607-13. https://doi.org/10.1016/j.biopsych.2008.10.037
Roerig JL, et al. An Exploration of the Effect of Modafinil On Olanzapine Associated Weight Gain in Normal Human Subjects. Biol Psychiatry. 2009 Apr 1;65(7):607-13. PubMed PMID: 19103435.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An exploration of the effect of modafinil on olanzapine associated weight gain in normal human subjects. AU - Roerig,James L, AU - Steffen,Kristine J, AU - Mitchell,James E, AU - Crosby,Ross D, AU - Gosnell,Blake A, Y1 - 2008/12/21/ PY - 2008/05/20/received PY - 2008/10/24/revised PY - 2008/10/24/accepted PY - 2008/12/24/entrez PY - 2008/12/24/pubmed PY - 2009/5/20/medline SP - 607 EP - 13 JF - Biological psychiatry JO - Biol. Psychiatry VL - 65 IS - 7 N2 - 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/m(2), 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. SN - 1873-2402 UR - https://www.unboundmedicine.com/medline/citation/19103435/An_exploration_of_the_effect_of_modafinil_on_olanzapine_associated_weight_gain_in_normal_human_subjects_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0006-3223(08)01383-8 DB - PRIME DP - Unbound Medicine ER -