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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02644577
Enrollment
110
Registered
2016-01-01
Start date
2012-06-30
Completion date
2015-09-30
Last updated
2016-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Keywords

Metformin, antipsychotic-induced metabolic syndrome, bipolar disorder

Brief summary

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

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.

Interventions

DRUGMetformin
OTHERStarch

Sponsors

China Medical University, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
the percentage of patients who had metabolic syndromeweek 24

Secondary

MeasureTime frame
body mass indexweek 24
blood pressureweek 24
fasting glucoseweek 24
lipid levelsweek 24

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026