Metformin for Treatment Antipsychotic-induced Metabolic Syndrome in Bipolar Disorder Patients

Sponsor

China Medical University, China (Other)

Overall Status

Completed

CT.gov ID

NCT02644577

Collaborator

(none)

110

Enrollment

Location

Arms

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to test the efficacy of metformin for treatment antipsychotic-induced metabolic syndrome in bipolar disorder patients.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder	Drug: Metformin Other: Starch	Phase 4

Detailed Description

Patients aged 18 to 45 years with bipolar disorder diagnosed in accordance with criteria set out in the Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV) were eligible for our study, and the Structured Clinical Interview of DSM-IV Axis I Disorders (SCID-1), Clinical Version, was used during the screening phase. To be qualified for this study, patients had to meet, 1) have experienced metabolic syndrome as defined below within the first year of treatment with one of four antipsychotics-clozapine, olanzapine, risperidone, or sulpiride; 2) had been either discharged from inpatient units or first visit in the outpatient clinic in the 12 months before enrollment, and their glucose and lipid levels, weight, blood pressure and antipsychotic treatment were documented; 3) had taken single antipsychotic medication, with no more than a 25% change in dosage, over the past 3 months. All participants had to be under the care of a parent or another adult caregiver who monitored and recorded the intake of medication daily during the trial to assure the adherence to medication. Patients were excluded from the study if there was evidence of liver or renal dysfunction, cardiovascular disease, or diabetes mellitus; or if they were pregnant or lactating; or had any psychiatric diagnosis other than schizophrenia.

The primary outcome was the level of LDL-C or the percentage of patients who had LDL-C greater or equal 3.37mmol/L (130mg/dl). The secondary outcomes were fasting triglyceride, total cholesterol, HDL-C, insulin and glucose levels, insulin resistance index, body weight and body mass index, as well as incidence of adverse events. Body mass index was calculated as weight in kilograms divided by height in meters squared. Insulin resistance index was calculated based on the homeostasis model assessment as: fasting insulin (mIU/L)×fasting glucose (mmol/L)/22.5. the assessment was conducted by members of a trained independent research team connected to the centre. Inclusion or exclusion was decided by the team. After a complete description of the study to the subjects, written informed consent was obtained in accordance with National Health and Medical Research Council guidelines.

Study Design

Study Type:

Interventional

Actual Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: metformin group Metformin 1000mg/day	Drug: Metformin
Placebo Comparator: placebo group starch	Other: Starch

Arm

Intervention/Treatment

Experimental: metformin group

Metformin 1000mg/day

Drug: Metformin

Placebo Comparator: placebo group

starch

Other: Starch

Outcome Measures

Primary Outcome Measures

the percentage of patients who had metabolic syndrome [week 24]

Secondary Outcome Measures

body mass index [week 24]
blood pressure [week 24]
fasting glucose [week 24]
lipid levels [week 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:
clinical diagnosis of bipolar disorder
have experienced metabolic syndrome as defined below within the first year of treatment with one of four antipsychotics-clozapine, olanzapine, risperidone, or sulpiride
had been either discharged from inpatient units or first visit in the outpatient clinic in the 12 months before enrollment, and their glucose and lipid levels, weight, blood pressure and antipsychotic treatment were documented
had taken single antipsychotic medication, with no more than a 25% change in dosage, over the past 3 months
must be under the care of a parent or another adult caregiver who monitored and recorded the intake of medication daily during the trial to assure the adherence to medication
Exclusion Criteria:
any psychiatric diagnosis other than schizophrenia
liver dysfunction
renal dysfunction
cardiovascular disease
diabetes mellitus
pregnancy
lactation period