Metformin for Treatment of Antipsychotic-induced Dyslipidemia

Overview[ - collapse ][ - ]

Purpose Almost all antipsychotics can induce dyslipidemia, but no treatment has been established. Metformin can improve lipid levels in obese patients. The investigators conducted a randomized, placebo-controlled study to test the efficacy of metformin for antipsychotic-induced dyslipidemia.
ConditionDyslipidemia
InterventionDrug: metformin
PhasePhase 4
SponsorCentral South University
Responsible PartyCentral South University
ClinicalTrials.gov IdentifierNCT01778244
First ReceivedJanuary 19, 2013
Last UpdatedJanuary 25, 2013
Last verifiedJanuary 2013

Tracking Information[ + expand ][ + ]

First Received DateJanuary 19, 2013
Last Updated DateJanuary 25, 2013
Start DateNovember 2008
Estimated Primary Completion DateJune 2012
Current Primary Outcome Measureslow-density lipoprotein cholesterol [Time Frame: 8 weeks] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • high-density lipoprotein cholesterol [Time Frame: 8 weeks] [Designated as safety issue: No]
  • adverse effects [Time Frame: 8 weeks] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief TitleMetformin for Treatment of Antipsychotic-induced Dyslipidemia
Official TitleMetformin for Treatment of Antipsychotic-induced Dyslipidemia: a Randomized, Double-blind Study
Brief Summary
Almost all antipsychotics can induce dyslipidemia, but no treatment has been established.
Metformin can improve lipid levels in obese patients. The investigators conducted a
randomized, placebo-controlled study to test the efficacy of metformin for
antipsychotic-induced dyslipidemia.
Detailed Description
The study was designed as a double-blind randomized controlled trial, with research
assessors and patients intended to be blind to the intervention status. The staff members
performing the assessment were not involved in implementing any aspect of the
intervention.162 patients were randomized to one of two 24-week individual treatments:
metformin (1000mg/day)or placebo. Medications were provided in double-blind fashion.The
assessments include lipid levels, body weight, body mass index, fasting glucose, fasting
insulin and insulin resistance index.
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ConditionDyslipidemia
InterventionDrug: metformin
1000mg/day for 24 weeks
Other Names:
metformin
Study Arm (s)
  • Experimental: metformin
    metformin
  • Placebo Comparator: placebo
    placebo

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment162
Estimated Completion DateJune 2012
Estimated Primary Completion DateDecember 2011
Eligibility Criteria
Inclusion Criteria:

Diagnostic and Statistical Manual of Mental Disorder-Fourth Edition (DSM-Ⅳ) criteria for
schizophrenia dyslipidemia after antipsycotic treatment the duration of illness was less
than 12 months taking only one antipsychotic stable outpatient the total score of Positive
and Negative Syndrome Scale (PANSS)≤60.

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Exclusion Criteria:

liver or renal diseases pregnant or lactating women cardiovascular diseases hypertension
or diabetes mellitus
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesChina

Administrative Information[ + expand ][ + ]

NCT Number NCT01778244
Other Study ID NumbersRRWu
Has Data Monitoring CommitteeYes
Information Provided ByCentral South University
Study SponsorCentral South University
CollaboratorsNot Provided
Investigators Principal Investigator: Renrong Wu, MD Central South University
Verification DateJanuary 2013

Locations[ + expand ][ + ]

Institute of Mental Health of The Second Xiangya Hospital, Central South University
Changsha, Hunan, China, 410011