Atomoxetine for weight reduction in obese women: a preliminary randomised controlled trial
Abstract
Background and objective Atomoxetine is a potent central norepinephrine uptake inhibitor, currently marketed for treatment of attention-deficit/hyperactivity disorder (ADHD). With the understanding that noradrenergic agents could be useful in assisting obese individuals to lose weight, we conducted this preliminary study to evaluate short-term efficacy and safety of atomoxetine in obese adults.Design At 12-week randomised, double-blind, placebo-controlled trial, conducted at Duke University Medical Centre, USA, from May 2004 to December 2004.Participants A total of 30 obese women (mean (s.e.) body mass index of 36.1 (0.6) kg/m2).Interventions Participants were randomly assigned to receive atomoxetine (n=15) or placebo (n=15). All participants were advised to follow a balanced hypocaloric diet (500 kcal/day deficit). Atomoxetine therapy was started at 25 mg/day orally, with gradual increase to 100 mg/day over 1 week. Placebo dosing was identical.Measurements Body weight in kilograms was the primary outcome measure. Other measurements included waist circumference, blood pressure and heart rate, fasting plasma glucose and lipids, and depressive symptoms.Results Last-observation-carried-forward analysis of the available data for participants who had completed at least one post-randomisation assessment, demonstrated that the atomoxetine group (n=12) lost more body weight over the 12-week period than the placebo (n=14) group (mean (s.e.) -3.6 (1.0) kg (-3.7% loss) vs 0.1 (0.4) kg (0.2% gain); F (4,96)=11.9; P<0.0001). Three participants in the atomoxetine group and none in the placebo group lost >or=5% weight. Side effects were minimal.Conclusion Atomoxetine demonstrated modest short-term weight loss efficacy relative to placebo in this preliminary study of obese women.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
These two parts of the same study are probably not yet sufficient evidence for ruling out growth problems as an adverse effect of atomoxetine, and there is one study describing the medication as an effective adjunct to weight loss in obese women.
“These two parts of the same study are probably not yet sufficient evidence for ruling out growth problems as an adverse effect of atomoxetine, and indeed there is one study describing the medication as an effective adjunct to weight loss in obese women [45]”
From European guidelines on managing adverse effects of medication for ADHD (2011) · cites this paper as [45]
Cites
Hamilton, M. (1960) · Journal of Neurology, Neurosurgery & Psychiatry · doi:10.1136/jnnp.23.1.56 · Cited by 32,817 · see citing works
(1998) · PsycEXTRA Dataset · doi:10.1037/e565682010-001 · Cited by 9,452 · see citing works
Beneficial health effects of modest weight loss.
Goldstein, D. J. (1992) · PubMed · Cited by 915 · see citing works
Yanovski, S. Z., & Yanovski, J. A. (2002) · New England Journal of Medicine · doi:10.1056/nejmra012586 · Cited by 544 · see citing works
Model for the regulation of energy balance and adiposity by the central nervous system
Schwartz, M. W., Baskin, D. G., Kaiyala, K. J., & Woods, S. C. (1999) · American Journal of Clinical Nutrition · doi:10.1093/ajcn/69.4.584 · Cited by 323 · see citing works
Thase, M. E. (1996) · Archives of General Psychiatry · doi:10.1001/archpsyc.1996.01830090023004 · Cited by 201 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
European guidelines on managing adverse effects of medication for ADHD
(for the European Guidelines Group), Graham, J., Banaschewski, T., Buitelaar, J., Coghill, D., Danckaerts, M., Dittmann, R. W., Döpfner, M., Hamilton, R., Hollis, C., et al. (2011) · European Child & Adolescent Psychiatry · doi:10.1007/s00787-010-0140-6 · Cited by 374 · see citing works
“These two parts of the same study are probably not yet sufficient evidence for ruling out growth problems as an adverse effect of atomoxetine, and indeed there is one study describing the medication as an effective adjunct to weight loss in obese women [45] (with similar studies examining similar outcomes for stimulan…”
ResultMcElroy, S. L., Hudson, J. I., Capece, J. A., Beyers, K., Fisher, A. C., & Rosenthal, N. R. (2007) · Biological Psychiatry · doi:10.1016/j.biopsych.2006.08.008 · Cited by 279 · see citing works
Attention-Deficit/Hyperactivity Disorder (ADHD) and Obesity: A Systematic Review of the Literature
Cortese, S., Angriman, M., Maffeis, C., Isnard, P., Konofal, É., Lecendreux, M., Purper‐Ouakil, D., Vincenzi, B., Bernardina, B. D., & Mouren, M. (2008) · Critical Reviews in Food Science and Nutrition · doi:10.1080/10408390701540124 · Cited by 271 · see citing works
Pharmacological Treatment of the Overweight Patient
Bray, G. A., & Greenway, F. L. (2007) · Pharmacological Reviews · doi:10.1124/pr.59.2.2 · Cited by 167 · see citing works
Obesity and ADHD: Clinical and Neurobiological Implications
Cortese, S., & Vincenzi, B. (2011) · Current topics in behavioral neurosciences · doi:10.1007/7854_2011_154 · Cited by 167 · see citing works
“Interestingly, a trial reported the efficacy of atomoxetine in weight reduction in obese women (Gadde et al. 2006).”
BackgroundElobeid, M. A., Padilla, M. A., McVie, T., Thomas, O., Brock, D. W., Musser, B., Lu, K., Coffey, C. S., Desmond, R. A., St-Onge, M.-P., et al. (2009) · PLoS ONE · doi:10.1371/journal.pone.0006624 · Cited by 158 · see citing works
Self-citationKim, J., Mutyala, B., Agiovlasitis, S., & Fernhall, B. (2011) · Preventive Medicine · doi:10.1016/j.ypmed.2011.01.003 · Cited by 158 · see citing works
Attention-deficit/hyperactivity disorder (ADHD) and binge eating.
Cortese, S., Bernardina, B. D., & Mouren, M.-C. (2008) · Nutrition Reviews · doi:10.1111/j.1753-4887.2007.tb00318.x · Cited by 147 · see citing works
“Moreover, Gadde et al.(45) recently published a trial on the efficacy of atomoxetine, the second-line medication for ADHD, in weight reduction in obese women.”
Backgroundvan Iersel, L., Brokke, K. E., Adan, R. A. H., Bulthuis, L. C. M., van den Akker, E. L. T., & van Santen, H. M. (2019) · Endocrine Reviews · doi:10.1210/er.2018-00017 · Cited by 146 · see citing works
Anti-obesity drugs and neural circuits of feeding
Adan, R. A. H., Vanderschuren, L. J. M. J., & ELAFLEUR, S. (2008) · Trends in Pharmacological Sciences · doi:10.1016/j.tips.2008.01.008 · Cited by 110 · see citing works
Recent Advances in Obesity Pharmacotherapy
Mayer, M. A., Höcht, C., Puyó, A. M., & Taira, C. A. (2009) · Current Clinical Pharmacology · doi:10.2174/157488409787236128 · Cited by 108 · see citing works
“In this study, atomoxetine was well tolerated with minimal side events [58].”
BackgroundComorbidity between ADHD and Obesity: Exploring Shared Mechanisms and Clinical Implications
Cortese, S., & Morcillo, C. (2010) · Postgraduate Medicine · doi:10.3810/pgm.2010.09.2205 · Cited by 102 · see citing works
Bupropion for weight reduction
Gadde, K. M., & Xiong, G. L. (2006) · Expert Review of Neurotherapeutics · doi:10.1586/14737175.7.1.17 · Cited by 64 · see citing works
Self-citationAtomoxetine: a novel treatment for child and adult ADHD
Ledbetter, M. (2006) · Neuropsychiatric Disease and Treatment · doi:10.2147/nedt.2006.2.4.455 · Cited by 43 · see citing works
“The atomoxetine group lost significantly more bodyweight than the placebo group (p<0.0001) and side-effects were reported as minimal (Gadde et al 2006).”
InfluentialA pharmacological analysis of stimulant-induced increases in smoking
Vansickel, A. R., Stoops, W. W., Glaser, P. E. A., & Rush, C. R. (2007) · Psychopharmacology · doi:10.1007/s00213-007-0786-z · Cited by 42 · see citing works
“…are distinct from commonly prescribed stimulant medications (e.g., Bymaster et al. 2002; Heil et al. 2002; Lile et al. 2006; Wee and Woolverton 2004), although it is prescribed for similar purposes (e.g., Carpenter et al. 2005; Gadde et al. 2006; Mignot and Nishino 2005; Simpson and Plosker 2004).”
BackgroundInfluentialPsychological Co-morbidities of Physical Illness
Pagoto, S. (2011) · Springer eBooks · doi:10.1007/978-1-4419-0029-6 · Cited by 42 · see citing works
Age-Grouped Differences in Adverse Drug Events from Psychotropic Medication
Safer, D. J. (2011) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2010.0152 · Cited by 38 · see citing works
“Obese adults can lose weight on atomoxetine (Gadde et al. 2006), but this ADE has not been reported for adults with ADHD (Simpson and Plosker 2004).”
Easton, N., Marshall, F. H., Fone, K. C. F., & Marsden, C. A. (2006) · Neuropharmacology · doi:10.1016/j.neuropharm.2006.09.024 · Cited by 37 · see citing works
Mukherjee, J., Baranwal, A., & Schade, K. N. (2016) · Current Diabetes Reviews · doi:10.2174/1573399812666160517115450 · Cited by 35 · see citing works
“Small change in weight in obese women [73].”
BackgroundThe Heartwarming Effect of Brown Adipose Tissue
Pinckard, K. M., & Stanford, K. I. (2021) · Molecular Pharmacology · doi:10.1124/molpharm.121.000328 · Cited by 33 · see citing works
“In humans, atomoxetine treatment has been shown to contribute to modest weight loss in adolescents (Wernicke and Kratochvil 2002) and adult women with obesity (Gadde et al., 2006).”
BackgroundAnderson, J. W. (2007) · Expert Opinion on Pharmacotherapy · doi:10.1517/14656566.8.11.1733 · Cited by 31 · see citing works
“The following approved prescription agents have shown efficacy in small trials, and are frequently used in an off-label manner to treat obesity: bupropion [18-20], topiramate [21,22], zonisamide [23] and atomoxitine [24].”
BackgroundHuman brown adipose tissue — function and therapeutic potential in metabolic disease
Bhatt, P. S., Dhillo, W. S., & Salem, V. (2017) · Current Opinion in Pharmacology · doi:10.1016/j.coph.2017.07.004 · Cited by 30 · see citing works
Gabriel, A., & Violato, C. (2011) · ADHD Attention Deficit and Hyperactivity Disorders · doi:10.1007/s12402-011-0063-1 · Cited by 30 · see citing works
“0001) over the 12-week period than the placebo (n = 14) group (Gadde et al. 2006).”
BackgroundHeTDR: Drug repositioning based on heterogeneous networks and text mining
Jin, S., Niu, Z., Jiang, C., Huang, W., Xia, F., Jin, X., Liu, X., & Zeng, X. (2021) · Patterns · doi:10.1016/j.patter.2021.100307 · Cited by 30 · see citing works
Investigational drugs for the treatment of binge eating disorder (BED): an update
Appolinário, J. C., Nardi, A. E., & McElroy, S. L. (2019) · Expert Opinion on Investigational Drugs · doi:10.1080/13543784.2019.1692813 · Cited by 28 · see citing works
“[35], it was evaluated in the treatment of individuals with BED”
MethodTizzano, J. P., Stribling, D. S., Pérez–Tilve, D., Strack, A. M., Frassetto, A., Chen, R. Z., Fong, T. M., Shearman, L. P., Krieter, P. A., Tschöp, M. H., et al. (2007) · Journal of Pharmacology and Experimental Therapeutics · doi:10.1124/jpet.107.133132 · Cited by 24 · see citing works
“, 2007), they produce only moderate, transient weight loss in obese subjects (Li et al., 2005; Gadde et al., 2006; Hainer et al., 2006).”
BackgroundMirbolooki, M., Constantinescu, C. C., Pan, M., & Mukherjee, J. (2012) · Synapse · doi:10.1002/syn.21617 · Cited by 24 · see citing works
“A preliminary study to evaluate short-term anti-obesity efficacy of atomoxetine demonstrated modest short-term weight loss in obese women (Gadde et al., 2006).”
BackgroundChapter 2 Recent Developments in Monoamine Reuptake Inhibitors
Liu, S., & Molino, B. F. (2007) · Annual reports in medicinal chemistry · doi:10.1016/s0065-7743(07)42002-4 · Cited by 22 · see citing works
Pott, W., Albayrak, Ö., Hinney, A., Hebebrand, J., & Pauli‐Pott, U. (2013) · Obesity Facts · doi:10.1159/000348792 · Cited by 22 · see citing works
Psychological Co-morbidities of Obesity
Pagoto, S., Schneider, K. L., Appelhans, B. M., Curtin, C., & Hajduk, A. M. (2011) · Springer eBooks · doi:10.1007/978-1-4419-0029-6_1 · Cited by 21 · see citing works
The Black Book of Psychotropic Dosing and Monitoring
DeBattista, C., & Schatzberg, A. F. (2025) · Psychopharmacology Bulletin · doi:10.64719/pb.4493 · Cited by 22 · see citing works
New agents in development for the management of obesity
Vincent, R. P., & le Roux, C. W. (2007) · International Journal of Clinical Practice · doi:10.1111/j.1742-1241.2007.01558.x · Cited by 17 · see citing works
Kaur, K. K. (2018) · MOJ Drug Design Development & Therapy · doi:10.15406/mojddt.2018.02.00057 · Cited by 11 · see citing works
5‐HT1AActivation Counteracts Cardiovascular But Not Hypophagic Effects of Sibutramine in Rats
Thomas, G. H., Babbs, A. J., Chatfield, R., Krülle, T. M., Widdowson, P. S., Provost, D., & McCormack, J. G. (2009) · Obesity · doi:10.1038/oby.2008.550 · Cited by 11 · see citing works
“A small randomized controlled 12-week trial in obese women with atomoxetine also reported some modest weight loss (33).”
BackgroundOff-label use of atomoxetine in adults: is it safe?
Dadashova, R., & Silverstone, P. H. (2012) · Mental Illness · doi:10.4081/mi.2012.e19 · Cited by 10 · see citing works
Yang, M., Chen, H., Johnson, M. L., Essien, E. J., Peters, R. J., Wang, X., & Abughosh, S. (2016) · Substance Use & Misuse · doi:10.3109/10826084.2015.1126744 · Cited by 10 · see citing works
“, 2012), several trials have demonstrated a lesser postcessation weight gain when using bupropion compared to varenicline or placebo (Gadde et al., 2006; Parsons et al., 2009).”
BackgroundResultInfluentialSilverstone, P. H., & Dadashova, R. (2012) · Annals of General Psychiatry · doi:10.1186/1744-859x-11-6 · Cited by 9 · see citing works
Pharmacotherapy for weight management.
Palatty, P. L., & Saldanha, E. (2012) · PubMed · Cited by 9 · see citing works
Attention Deficit/Hyperactivity Disorder and the Clinical Management of Obesity
Pagoto, S., Curtin, C., Appelhans, B. M., & Alonso‐Alonso, M. (2012) · Current Obesity Reports · doi:10.1007/s13679-012-0012-0 · Cited by 8 · see citing works
Fu, D., Guo, H., Hu, Y., Fang, W., Liu, Q., Xu, J., Wu, D., & Chen, F. (2023) · European Journal of Clinical Pharmacology · doi:10.1007/s00228-022-03449-1 · Cited by 7 · see citing works
Baranwal, A., Mirbolooki, M., & Mukherjee, J. (2015) · Molecular Imaging · doi:10.2310/7290.2015.00028 · Cited by 7 · see citing works
“A recent study using atomoxetine in obese women had a small effect on shortterm weight loss.(19) The sensitivity to detect this enhanced BAT metabolic activity via the β3-adrenoceptor by Cl316,243 activation using the [(18)F]FDG PET/CT method may therefore be useful in the development and evaluation of novel treatment…”
MethodVollbrecht, P. J., Nesbitt, K. M., Mabrouk, O. S., Chadderdon, A. M., Jutkiewicz, E. M., Kennedy, R. T., & Ferrario, C. R. (2017) · Behavioural Brain Research · doi:10.1016/j.bbr.2017.11.009 · Cited by 4 · see citing works
“These data are consistent with human studies demonstrating effectiveness of the NET inhibitor atomoxetine in reducing body weight in individuals with obesity and binge eating behaviors [64,65] and with reductions in food intake and weight in response to a general monoamine reuptake inhibitor, tesofensine, or the NET i…”
ResultThe Treatment of Adult ADHD: Complexity at Hand
Pallanti, S., & Salerno, L. (2020) · Springer eBooks · doi:10.1007/978-3-030-39051-8_19 · Cited by 3 · see citing works
Pharmacological manipulation of impulsivity: A randomized controlled trial
Kulendran, M., Wingfield, L. R., Sugden, C., Darzi, A. W., & Vlaev, I. (2015) · Personality and Individual Differences · doi:10.1016/j.paid.2015.11.025 · Cited by 3 · see citing works
The Relationship Between Binge Eating and Attention Deficit Hyperactivity Disorder
Kaplan, A. S., Howlett, A., Yılmaz, Z., & Levitan, R. D. (2016) · Springer eBooks · doi:10.1007/978-3-319-32742-6_1 · Cited by 2 · see citing works
Bipolar disorders, obesity, and metabolic disturbances: Mechanisms and implications
Murru, A., Anmella, G., Giménez, A., & Vieta, E. (2020) · Elsevier eBooks · doi:10.1016/b978-0-12-819182-8.00022-3 · Cited by 2 · see citing works
Analyzing Black Market Sales of the Second-Line ADHD Medication Atomoxetine
Roe, S. A., DeSalve, D. S., & Piper, B. J. (2023) · Pharmacoepidemiology · doi:10.3390/pharma2040027 · Cited by 1 · see citing works
“Data included the generic drug name, drug dosage, purchase price, and date and location of submission in the United States from 2015 to 2019 for atomoxetine.”
BackgroundTaracena, M. T. D. L., & Rada, F. M. (2007) · Psiquiatría Biológica · doi:10.1016/s1134-5934(07)73255-4 · Cited by 1 · see citing works
Adult ADHD in Feeding and Eating Disorders
Pallanti, S., & Salerno, L. (2020) · Springer eBooks · doi:10.1007/978-3-030-39051-8_14 · Cited by 1 · see citing works
Treatment-Related Evidence that Food Addiction Is a Valid Construct
Wilcox, C. E., & Farrar, D. C. (2021) · Springer eBooks · doi:10.1007/978-3-030-83078-6_10 · Cited by 1 · see citing works
Pharmacological Management of the Obese Patient
Schumacher, D. (2013) · American Journal of Lifestyle Medicine · doi:10.1177/1559827613504733
“2% placebo weight gain.(73)) The most common side effect reported”
BackgroundEl TDAH y su relación con la obesidad a lo largo de la vida.
López, C. R. (2013) · RUC (Universidade Da Coruña)
Appetite and weight loss in children on atomoxetine therapy: an exploratory clinical study
Deshmukh, A., Deshmukh, V., Shah, M. J., Karira, A., Karia, S., Shah, N., Sonavane, S., & Sousa, A. D. (2016) · International Journal of Contemporary Pediatrics · doi:10.18203/2349-3291.ijcp20162388
Neuropsychopharmacology of appetite in healthy volunteers
Thomas, J. M. (2015) · University of Birmingham Institutional Research Archive (University of Birmingham)
Dadashova, R. (2011) · ERA: Education and Research Archive (University of Alberta) · doi:10.7939/r3xh8f
No stimulant? No Problem: Analyzing Black Market Sales of Atomoxetine on StreetRxPreprint
Roe, S. A., DeSalve, D. S., & Piper, B. J. (2022) · medRxiv · doi:10.1101/2022.12.19.22283638
“It is also possible that purchasers were using atomoxetine to combat the effects of alcohol, produce sexual effects, and limit body weight, given existing research documenting all of these uses (Gadde et al., 2006).”
Background
- Authors
- Gadde, K. M., Yonish, G. M., Wagner, H. R., Foust, M. S., & Allison, D. B.
- Affiliations
- Duke University (US)
- University of Alabama at Birmingham (US)
- Corresponding author
- Gadde, K M
- Venue
- International Journal of Obesity
- Published
- 2006-01-17
- Volume
- 30
- Issue
- 7
- Pages
- 1138-1142
- ISSN
- 0307-0565 (ISSN-L)
- 1476-5497
- OpenAlex
- W1985702287
- Cited by
- 56
- References
- 6
- Citations by year
- 2025: 1 · 2023: 2 · 2022: 1 · 2021: 3 · 2020: 3 · 2019: 1 · 2018: 2 · 2017: 2 · 2016: 4 · 2015: 3 · 2013: 3 · 2012: 5
- FWCI
- 3.55
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- www.springer.com/tdm (tdm)
- Locations
- International Journal of Obesity (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Eli Lilly and Company
- Topics
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Life Sciences › Neuroscience › Endocrine and Autonomic Systems › Regulation of Appetite and Obesity
- Social Sciences › Psychology › Clinical Psychology › Eating Disorders and Behaviors
- Keywords
- atomoxetine, obesity, weight loss, noradrenergic agents, norepinephrine reuptake inhibitors, women, hypocaloric diet, body weight, waist circumference, blood pressure, lipids, fasting blood glucose, depressive symptoms, drug safety
- MeSH terms
- Atomoxetine Hydrochloride, Adolescent, Adult, Double-Blind Method, Female, Humans, Middle Aged, Obesity, Propylamines, Weight Loss, Body Mass Index, Treatment Outcome, Adrenergic Uptake Inhibitors, Anti-Obesity Agents
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review