TY - JOUR
T1 - A Randomized, Placebo-Controlled Trial of Metformin for the Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorder
T2 - Open-Label Extension
AU - Handen, Benjamin L.
AU - Anagnostou, Evdokia
AU - Aman, Michael G.
AU - Sanders, Kevin B.
AU - Chan, James
AU - Hollway, Jill A.
AU - Brian, Jessica
AU - Arnold, L. Eugene
AU - Capano, Lucia
AU - Williams, Craig
AU - Hellings, Jessica A.
AU - Butter, Eric
AU - Mankad, Deepali
AU - Tumuluru, Rameshwari
AU - Kettel, Jessica
AU - Newsom, Cassandra R.
AU - Peleg, Naomi
AU - Odrobina, Dina
AU - McAuliffe-Bellin, Sarah
AU - Marler, Sarah
AU - Wong, Taylor
AU - Wagner, Alexis
AU - Hadjiyannakis, Stasia
AU - Macklin, Eric A.
AU - Veenstra-VanderWeele, Jeremy
N1 - Publisher Copyright:
© 2017 American Academy of Child and Adolescent Psychiatry
PY - 2017/10
Y1 - 2017/10
N2 - Objective A previous study reported on a 16-week placebo-controlled, randomized clinical trial (RCT) of metformin for weight stabilization in 61 children and adolescents 6 to 17 years old with autism spectrum disorder who were prescribed atypical antipsychotics. The present study describes the results of a 16-week open-label extension. Method Fifty-two participants from the acute trial (85%) entered the extension; 22 had been on metformin during the initial RCT and 30 had been on placebo. Participants were re-titrated to 500 mg twice a day (6- to 9-year-olds) or 850 mg twice a day (10- to 17-year-olds) during the open-label extension. Primary outcome measure was change in body mass index (BMI) z-score after 16 weeks; secondary outcomes were change in additional body composition and metabolic parameters. Results After 16 weeks of open-label treatment, participants initially taking placebo during the RCT had lower BMI z-scores (mean 16-week change −0.10, p =.004). Statistically significant improvements also were noted in secondary body composition measures (weight z-score and BMI and weight percentile) but not in metabolic variables. Participants who initially had been taking metformin during the 16-week RCT maintained prior decreases in BMI z-scores but did not have additional weight loss. Three participants discontinued treatment because of an adverse event. No significant changes were noted on metabolic measures, although the decrease in hemoglobin A1c was large (∼1 mmol) and consistent across the acute and open-label phases. Conclusion Metformin can be effective for decreasing weight gain associated with atypical antipsychotic use and maintaining prior improvement in children and adolescents with autism spectrum disorder. Clinical trial registration information—Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD); http://clinicaltrials.gov/; NCT01825798.
AB - Objective A previous study reported on a 16-week placebo-controlled, randomized clinical trial (RCT) of metformin for weight stabilization in 61 children and adolescents 6 to 17 years old with autism spectrum disorder who were prescribed atypical antipsychotics. The present study describes the results of a 16-week open-label extension. Method Fifty-two participants from the acute trial (85%) entered the extension; 22 had been on metformin during the initial RCT and 30 had been on placebo. Participants were re-titrated to 500 mg twice a day (6- to 9-year-olds) or 850 mg twice a day (10- to 17-year-olds) during the open-label extension. Primary outcome measure was change in body mass index (BMI) z-score after 16 weeks; secondary outcomes were change in additional body composition and metabolic parameters. Results After 16 weeks of open-label treatment, participants initially taking placebo during the RCT had lower BMI z-scores (mean 16-week change −0.10, p =.004). Statistically significant improvements also were noted in secondary body composition measures (weight z-score and BMI and weight percentile) but not in metabolic variables. Participants who initially had been taking metformin during the 16-week RCT maintained prior decreases in BMI z-scores but did not have additional weight loss. Three participants discontinued treatment because of an adverse event. No significant changes were noted on metabolic measures, although the decrease in hemoglobin A1c was large (∼1 mmol) and consistent across the acute and open-label phases. Conclusion Metformin can be effective for decreasing weight gain associated with atypical antipsychotic use and maintaining prior improvement in children and adolescents with autism spectrum disorder. Clinical trial registration information—Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD); http://clinicaltrials.gov/; NCT01825798.
KW - antipsychotic medication
KW - autism spectrum disorder
KW - metformin
KW - weight gain
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U2 - 10.1016/j.jaac.2017.07.790
DO - 10.1016/j.jaac.2017.07.790
M3 - Article
C2 - 28942807
AN - SCOPUS:85030317816
SN - 0890-8567
VL - 56
SP - 849-856.e6
JO - Journal of the American Academy of Child and Adolescent Psychiatry
JF - Journal of the American Academy of Child and Adolescent Psychiatry
IS - 10
ER -