Abstract | BACKGROUND:
Metformin has been used for alleviating metabolic abnormalities in patients with schizophrenia. The lowest dose of metformin to treat metabolic abnormalities in clozapine-treated patients is 1000 mg/d. This study was designed to determine whether metformin at 500 mg/d and 1000 mg/d is effective in improving the metabolic profiles of clozapine-treated patients with pre-existing metabolic abnormalities, and whether its effectiveness depends on metformin dosage. METHODS: In this 12-week, randomized, double-blind, placebo-controlled trial, metformin at 500 mg/d or 1000 mg/d was prescribed to clozapine-treated patients with schizophrenia who had pre-existing metabolic abnormalities. The recruited patients underwent physical and laboratory evaluations at weeks 4, 8, and 12. The outcomes were any changes in metabolic traits. RESULTS: Among the 96 clozapine-treated patients with schizophrenia screened for the trial, 55 patients with pre-existing metabolic abnormalities were randomly assigned to placebo (n = 18), metformin dosage at 500 mg/d (n = 18), and metformin dosage at 1000 mg/d (n = 19) groups. The body weight (BW) of patients in the metformin 1000 mg/d group significantly decreased, by a mean of 0.97 kg over the 12 week trial period. Moreover, patients in the metformin at 500 mg/d and 1000 mg/d groups had a significant decrease in body mass index (BMI) after 12 weeks, with the mean decrease being 0.70 and 0.50 kg/m2, respectively. No significant changes were observed in the other metabolic parameters of patients in the three groups. CONCLUSIONS: Our results demonstrated that a low metformin dosage of either 500 mg/d or 1000 mg/d for 12 weeks slightly reduced the BW and BMI of clozapine-treated patients with pre-existing metabolic abnormalities. A longer period of treatment with a larger sample is warranted to determine the factors that influence the metformin treatment response. TRIAL REGISTRATION: ClinicalTrials.gov NCT02751307.
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Authors | Chih-Chiang Chiu, Mong-Liang Lu, Ming-Chyi Huang, Po-Yu Chen, Yen-Kuang Lin, Shih-Ku Lin, Chun-Hsin Chen |
Journal | PloS one
(PLoS One)
Vol. 11
Issue 12
Pg. e0168347
( 2016)
ISSN: 1932-6203 [Electronic] United States |
PMID | 27973619
(Publication Type: Journal Article, Randomized Controlled Trial)
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Chemical References |
- Antipsychotic Agents
- Hypoglycemic Agents
- Metformin
- Clozapine
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Topics |
- Adult
- Antipsychotic Agents
(administration & dosage)
- Body Mass Index
- Body Weight
(drug effects)
- Clozapine
(administration & dosage)
- Double-Blind Method
- Female
- Humans
- Hypoglycemic Agents
(administration & dosage)
- Insulin Resistance
(physiology)
- Male
- Metformin
(administration & dosage)
- Middle Aged
- Schizophrenia
(drug therapy, metabolism)
- Treatment Outcome
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