Effects of Adjunctive Metformin on Metabolic Profiles in Clozapine-treated Schizophrenic Patients
Recruitment status was Recruiting
Background: Several studies have suggested that clozapine has the greatest propensity of all available atypical antipsychotics to induce weight gain and metabolic dysregulation. So it is necessary to conduct some interventions to prevent or treat metabolic dysregulation induced by clozapine.
Metformin has been reported to achieve weight loss in several groups of patients characterized by insulin resistance. Several studies evaluated the effects of metformin on antipsychotics-induced weight gain and study period lasted from 8 to 16 weeks. Long-term metformin use had more robust effect on metabolic dysregulation and body weight in non-psychiatric field.
Goals: The study goals are two-fold. The first goal is to estimate the prevalence of metabolic dysregulation among clozapine-treated schizophrenic patients in Taiwan. The second goal is to assess the reversal effect of metformin on metabolic disturbance among clozapine-treated schizophrenic patients in a 24-week double-blind, placebo-control trial. The investigators will use metformin 1500 mg/d or placebo in the second phase trial.
Methods: This study will be divided into two phases. The first phase is to estimate the prevalence of metabolic disturbances among clozapine-treated patients. The second will be a randomized, double-blind, and placebo-controlled study of adjunctive metformin for non-DM clozapine-treated patients.
The clozapine dosage was maintained unchanged during the study period. The eligible patients will be randomly assigned to either metformin or identical placebo pills. Metformin will be titrated to 1500 mg/day in 4 weeks. Patients' blood pressure (BP), waist circumference, body weight, fasting plasma glucose (FPG), triglyceride (TG), high-density lipoprotein cholesterol (HDL), insulin, and leptin will be measured at 2, 4, 8, 16, and 24 weeks after the start of metformin.
In a 3-year period, the investigators estimate to recruit 150 clozapine-treated patients in the first phase and 75 fulfill the second phase criteria. The investigators estimate 60 patients complete the second phase intervention (staying in second phase at least 4 weeks).
From this study, the investigators would like to know the prevalence of metabolic dysregulation among clozapine-treated schizophrenic patients and to know the effect of metformin on metabolic profile among non-DM clozapine treated patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Prevalence of Metabolic Syndrome and Effects of Adjunctive Metformin on Metabolic Profiles in Clozapine-treated Schizophrenic Patients|
- body weight change [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]We measure body weight before and after intervention, at week 2, 4, 8, 16, 24
- metabolic features [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]Our secondary outcomes included waist circumference, blood pressure, triglyceride, HDL-C, fasting glucose and insulin.
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||July 2011|
|Estimated Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Active Comparator: metformin
metformin intervention group
metformin 500 mg/pill; target dose 1500 mg/day for 24 weeks
Other Name: Diaformin 500 mg/pill
Placebo Comparator: placebo
identical-appearing pill of placebo
Other Name: Diaformin 500 mg/pill identical-appearing placebo
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01300637
|Contact: Chun-Hsin Chen, MD||886-2-29307930 ext firstname.lastname@example.org|
|Contact: Mong-Liang Lu, MD||886-2-29307930 ext email@example.com|
|Taipei Medical University-WanFang Hospital||Recruiting|
|Taipei, Taiwan, 116|
|Contact: Chun-Hsin Chen, MD 886-2-29307930 ext 53961 firstname.lastname@example.org|
|Contact: Mong-Liang Lu, MD 886-2-29307930 ext 53961 email@example.com|
|Principal Investigator:||Chun-Hsin Chen, MD||Taipei Medical University-WanFang Hospital, Taipei, Taiwan|