A Randomized, Double-Blind, Placebo-Controlled Trial of Metformin Treatment of Weight Gain Associated With Initiation of Atypical Antipsychotic Therapy in Children and Adolescents
Objective: Second-generation, or atypical, antipsychotics effectively treat psychiatric illness in children and adolescents. However, weight gain and abnormalities in insulin sensitivity, including diabetes, complicate this therapy. Method: A 16-week double-blind, placebo-controlled trial was conduc...
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| Published in | The American journal of psychiatry Vol. 163; no. 12; pp. 2072 - 2079 |
|---|---|
| Main Authors | , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Washington, DC
American Psychiatric Association
01.12.2006
|
| Subjects | |
| Online Access | Get full text |
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| Abstract | Objective:
Second-generation, or atypical, antipsychotics effectively treat psychiatric illness in children and adolescents. However, weight gain and abnormalities in insulin sensitivity, including diabetes, complicate this therapy.
Method:
A 16-week double-blind, placebo-controlled trial was conducted to evaluate the effectiveness of metformin in managing weight gain in 39 subjects, ages 10-17, whose weight had increased by more than 10% during less than 1 year of olanzapine, risperidone, or quetiapine therapy. Body weight, body mass index (kilograms per square meter of height), and waist circumference were measured regularly, as were fasting insulin and glucose levels.
Results:
Weight was stabilized in subjects receiving metformin, while those receiving placebo continued to gain weight (0.31 kg week). Because the study was conducted with growing children, metformin treatment resulted in reduction in z scores for both weight and body mass index. The homeostasis model assessment, a surrogate indicator of insulin sensitivity, decreased in treated subjects. Overt diabetes was diagnosed in two subjects before treatment (elevated baseline fasting glucose and insulin values) and in two placebo-treated subjects (one at week 12 and the other after study completion). One subject taking placebo developed impaired fasting glucose. Placebo treatment was associated with the need to perform oral glucose tolerance testing upon study completion, by which three additional subjects were identified with impaired glucose tolerance. No serious adverse events resulted from metformin treatment.
Conclusions:
Metformin therapy is safe and effective in abrogating weight gain, decreased insulin sensitivity, and abnormal glucose metabolism resulting from treatment of children and adolescents with atypicals. |
|---|---|
| AbstractList | Second-generation, or atypical, antipsychotics effectively treat psychiatric illness in children and adolescents. However, weight gain and abnormalities in insulin sensitivity, including diabetes, complicate this therapy.OBJECTIVESecond-generation, or atypical, antipsychotics effectively treat psychiatric illness in children and adolescents. However, weight gain and abnormalities in insulin sensitivity, including diabetes, complicate this therapy.A 16-week double-blind, placebo-controlled trial was conducted to evaluate the effectiveness of metformin in managing weight gain in 39 subjects, ages 10-17, whose weight had increased by more than 10% during less than 1 year of olanzapine, risperidone, or quetiapine therapy. Body weight, body mass index (kilograms per square meter of height), and waist circumference were measured regularly, as were fasting insulin and glucose levels.METHODA 16-week double-blind, placebo-controlled trial was conducted to evaluate the effectiveness of metformin in managing weight gain in 39 subjects, ages 10-17, whose weight had increased by more than 10% during less than 1 year of olanzapine, risperidone, or quetiapine therapy. Body weight, body mass index (kilograms per square meter of height), and waist circumference were measured regularly, as were fasting insulin and glucose levels.Weight was stabilized in subjects receiving metformin, while those receiving placebo continued to gain weight (0.31 kg/week). Because the study was conducted with growing children, metformin treatment resulted in reduction in z scores for both weight and body mass index. The homeostasis model assessment, a surrogate indicator of insulin sensitivity, decreased in treated subjects. Overt diabetes was diagnosed in two subjects before treatment (elevated baseline fasting glucose and insulin values) and in two placebo-treated subjects (one at week 12 and the other after study completion). One subject taking placebo developed impaired fasting glucose. Placebo treatment was associated with the need to perform oral glucose tolerance testing upon study completion, by which three additional subjects were identified with impaired glucose tolerance. No serious adverse events resulted from metformin treatment.RESULTSWeight was stabilized in subjects receiving metformin, while those receiving placebo continued to gain weight (0.31 kg/week). Because the study was conducted with growing children, metformin treatment resulted in reduction in z scores for both weight and body mass index. The homeostasis model assessment, a surrogate indicator of insulin sensitivity, decreased in treated subjects. Overt diabetes was diagnosed in two subjects before treatment (elevated baseline fasting glucose and insulin values) and in two placebo-treated subjects (one at week 12 and the other after study completion). One subject taking placebo developed impaired fasting glucose. Placebo treatment was associated with the need to perform oral glucose tolerance testing upon study completion, by which three additional subjects were identified with impaired glucose tolerance. No serious adverse events resulted from metformin treatment.Metformin therapy is safe and effective in abrogating weight gain, decreased insulin sensitivity, and abnormal glucose metabolism resulting from treatment of children and adolescents with atypicals.CONCLUSIONSMetformin therapy is safe and effective in abrogating weight gain, decreased insulin sensitivity, and abnormal glucose metabolism resulting from treatment of children and adolescents with atypicals. Second-generation, or atypical, antipsychotics effectively treat psychiatric illness in children and adolescents. However, weight gain and abnormalities in insulin sensitivity, including diabetes, complicate this therapy. A 16-week double-blind, placebo-controlled trial was conducted to evaluate the effectiveness of metformin in managing weight gain in 39 subjects, ages 10-17, whose weight had increased by more than 10% during less than 1 year of olanzapine, risperidone. or quetiapine therapy. Body weight, body mass index (kilograms per square meter of height), and waist circumference were measured regularly, as were fasting insulin and glucose levels. Weight was stabilized in subjects receiving metformin, while those receiving placebo continued to gain weight (0.31 kg/week). Because the study was conducted with growing children, metformin treatment resulted in reduction in z scores for both weight and body mass index. The homeostasis model assessment, a surrogate indicator of insulin sensitivity, decreased in treated subjects. Overt diabetes was diagnosed in two subjects before treatment (elevated baseline fasting glucose and insulin values) and in two placebo-treated subjects (one at week 12 and the other after study completion). One subject taking placebo developed impaired fasting glucose. Placebo treatment was associated with the need to perform oral glucose tolerance testing upon study completion, by which three additional subjects were identified with impaired glucose tolerance. No serious adverse events resulted from metformin treatment. Metformin therapy is safe and effective in abrogating weight gain, decreased insulin sensitivity, and abnormal glucose metabolism resulting from treatment of children and adolescents with atypicals. Second-generation, or atypical, antipsychotics effectively treat psychiatric illness in children and adolescents. However, weight gain and abnormalities in insulin sensitivity, including diabetes, complicate this therapy. A 16-week double-blind, placebo-controlled trial was conducted to evaluate the effectiveness of metformin in managing weight gain in 39 subjects, ages 10-17, whose weight had increased by more than 10% during less than 1 year of olanzapine, risperidone, or quetiapine therapy. Body weight, body mass index (kilograms per square meter of height), and waist circumference were measured regularly, as were fasting insulin and glucose levels. Weight was stabilized in subjects receiving metformin, while those receiving placebo continued to gain weight (0.31 kg/week). Because the study was conducted with growing children, metformin treatment resulted in reduction in z scores for both weight and body mass index. The homeostasis model assessment, a surrogate indicator of insulin sensitivity, decreased in treated subjects. Overt diabetes was diagnosed in two subjects before treatment (elevated baseline fasting glucose and insulin values) and in two placebo-treated subjects (one at week 12 and the other after study completion). One subject taking placebo developed impaired fasting glucose. Placebo treatment was associated with the need to perform oral glucose tolerance testing upon study completion, by which three additional subjects were identified with impaired glucose tolerance. No serious adverse events resulted from metformin treatment. Metformin therapy is safe and effective in abrogating weight gain, decreased insulin sensitivity, and abnormal glucose metabolism resulting from treatment of children and adolescents with atypicals. OBJECTIVE: Second-generation, or atypical, antipsychotics effectively treat psychiatric illness in children and adolescents. However, weight gain and abnormalities in insulin sensitivity, including diabetes, complicate this therapy. METHOD: A 16-week double-blind, placebo-controlled trial was conducted to evaluate the effectiveness of metformin in managing weight gain in 39 subjects, ages 10-17, whose weight had increased by more than 10% during less than 1 year of olanzapine, risperidone, or quetiapine therapy. Body weight, body mass index (kilograms per square meter of height), and waist circumference were measured regularly, as were fasting insulin and glucose levels. RESULTS: Weight was stabilized in subjects receiving metformin, while those receiving placebo continued to gain weight (0.31 kg/week). Because the study was conducted with growing children, metformin treatment resulted in reduction in z scores for both weight and body mass index. The homeostasis model assessment, a surrogate indicator of insulin sensitivity, decreased in treated subjects. Overt diabetes was diagnosed in two subjects before treatment (elevated baseline fasting glucose and insulin values) and in two placebo-treated subjects (one at week 12 and the other after study completion). One subject taking placebo developed impaired fasting glucose. Placebo treatment was associated with the need to perform oral glucose tolerance testing upon study completion, by which three additional subjects were identified with impaired glucose tolerance. No serious adverse events resulted from metformin treatment. CONCLUSIONS: Metformin therapy is safe and effective in abrogating weight gain, decreased insulin sensitivity, and abnormal glucose metabolism resulting from treatment of children and adolescents with atypicals. Objective: Second-generation, or atypical, antipsychotics effectively treat psychiatric illness in children and adolescents. However, weight gain and abnormalities in insulin sensitivity, including diabetes, complicate this therapy. Method: A 16-week double-blind, placebo-controlled trial was conducted to evaluate the effectiveness of metformin in managing weight gain in 39 subjects, ages 10-17, whose weight had increased by more than 10% during less than 1 year of olanzapine, risperidone, or quetiapine therapy. Body weight, body mass index (kilograms per square meter of height), and waist circumference were measured regularly, as were fasting insulin and glucose levels. Results: Weight was stabilized in subjects receiving metformin, while those receiving placebo continued to gain weight (0.31 kg week). Because the study was conducted with growing children, metformin treatment resulted in reduction in z scores for both weight and body mass index. The homeostasis model assessment, a surrogate indicator of insulin sensitivity, decreased in treated subjects. Overt diabetes was diagnosed in two subjects before treatment (elevated baseline fasting glucose and insulin values) and in two placebo-treated subjects (one at week 12 and the other after study completion). One subject taking placebo developed impaired fasting glucose. Placebo treatment was associated with the need to perform oral glucose tolerance testing upon study completion, by which three additional subjects were identified with impaired glucose tolerance. No serious adverse events resulted from metformin treatment. Conclusions: Metformin therapy is safe and effective in abrogating weight gain, decreased insulin sensitivity, and abnormal glucose metabolism resulting from treatment of children and adolescents with atypicals. |
| Author | Klein, David J. Cottingham, Elizabeth M. Barton, Bruce A. Sorter, Michael Morrison, John A. |
| Author_xml | – sequence: 1 givenname: David J. surname: Klein fullname: Klein, David J. – sequence: 2 givenname: Elizabeth M. surname: Cottingham fullname: Cottingham, Elizabeth M. – sequence: 3 givenname: Michael surname: Sorter fullname: Sorter, Michael – sequence: 4 givenname: Bruce A. surname: Barton fullname: Barton, Bruce A. – sequence: 5 givenname: John A. surname: Morrison fullname: Morrison, John A. |
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| References_xml | – ident: p_16 doi: 10.1056/NEJMoa050156 – ident: p_12 doi: 10.1345/aph.1D423a – ident: p_18 doi: 10.1542/peds.107.4.e55 – ident: p_22 doi: 10.1007/BF00280883 – ident: p_27 doi: 10.1016/j.braindev.2004.06.006 – ident: p_4 doi: 10.2165/00023210-200418140-00006 – ident: p_6 doi: 10.1007/s00125-004-1641-y – ident: p_1 doi: 10.1001/archpedi.159.4.362 – ident: p_21 doi: 10.2337/diacare.27.2.378 – volume: 28 start-page: S1 year: 2006 ident: p_23 publication-title: Diabetes Care – ident: p_20 doi: 10.1016/S0022-3476(05)83176-2 – ident: p_2 doi: 10.1097/01.chi.0000157543.74509.c8 – ident: p_14 doi: 10.1038/oby.2002.77 – ident: p_10 doi: 10.1056/NEJMoa051688 – ident: p_19 doi: 10.1176/appi.ajp.159.4.655 – ident: p_26 doi: 10.1176/appi.ajp.162.9.1744 – ident: p_11 doi: 10.1210/jcem.87.6.8599 – ident: p_9 doi: 10.1089/cap.1998.8.151 – ident: p_13 doi: 10.1056/NEJMoa012512 – ident: p_8 doi: 10.2337/diabetes.54.3.862 – ident: p_5 doi: 10.1001/archpsyc.60.6.553 – volume-title: Johnson CL: 2000 CDC Growth Charts for the United States: methods and development. Vital Health Stat 11 2002 ident: p_24 – volume: 66 start-page: 29 year: 2005 ident: p_3 publication-title: J Clin Psychiatry – ident: p_7 doi: 10.1001/archpsyc.62.1.19 – ident: p_25 doi: 10.1176/appi.ajp.162.5.954 – ident: p_15 doi: 10.1001/archinte.161.2.218 – ident: p_17 doi: 10.1097/00004850-200207000-00001 – reference: 28469583 - Front Psychiatry. 2017 Apr 19;8:59 – reference: 17151148 - Am J Psychiatry. 2006 Dec;163(12):2034-6 |
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Second-generation, or atypical, antipsychotics effectively treat psychiatric illness in children and adolescents. However, weight gain and... Second-generation, or atypical, antipsychotics effectively treat psychiatric illness in children and adolescents. However, weight gain and abnormalities in... OBJECTIVE: Second-generation, or atypical, antipsychotics effectively treat psychiatric illness in children and adolescents. However, weight gain and... |
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| SubjectTerms | Adolescent Age Factors Antipsychotic Agents - adverse effects Antipsychotic Agents - therapeutic use Biological and medical sciences Blood Glucose - analysis Body Mass Index Changes Child Children & youth Clinical outcomes Diabetes Mellitus, Type 2 - chemically induced Diabetes Mellitus, Type 2 - drug therapy Diabetes Mellitus, Type 2 - prevention & control Double-Blind Method Drug therapy Glucose Tolerance Test Humans Hypoglycemic Agents - therapeutic use Insulin - blood Insulin Resistance Intellectual disabilities Medical sciences Mental Disorders - drug therapy Mental Disorders - metabolism Metformin - therapeutic use Obesity - chemically induced Obesity - drug therapy Patients Placebos Psychology. Psychoanalysis. Psychiatry Psychopathology. Psychiatry Psychotropic drugs Risk factors Side effects Studies Weight Weight Gain - drug effects |
| Title | A Randomized, Double-Blind, Placebo-Controlled Trial of Metformin Treatment of Weight Gain Associated With Initiation of Atypical Antipsychotic Therapy in Children and Adolescents |
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