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Metformin for Treatment of Antipsychotic-induced Dyslipidemia

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ClinicalTrials.gov Identifier: NCT01778244
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : January 29, 2013
Sponsor:
Information provided by (Responsible Party):
Jingping Zhao, Central South University

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.

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: metformin Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Metformin for Treatment of Antipsychotic-induced Dyslipidemia: a Randomized, Double-blind Study
Study Start Date : November 2008
Primary Completion Date : December 2011
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: metformin
metformin
Drug: metformin
1000mg/day for 24 weeks
Placebo Comparator: placebo
placebo



Primary Outcome Measures :
  1. low-density lipoprotein cholesterol [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. high-density lipoprotein cholesterol [ Time Frame: 8 weeks ]
  2. adverse effects [ Time Frame: 8 weeks ]

Other Outcome Measures:
  1. body mass index [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Exclusion Criteria:

liver or renal diseases pregnant or lactating women cardiovascular diseases hypertension or diabetes mellitus


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778244


Locations
China, Hunan
Institute of Mental Health of The Second Xiangya Hospital, Central South University
Changsha, Hunan, China, 410011
Sponsors and Collaborators
Central South University
Investigators
Principal Investigator: Renrong Wu, MD Central South University

Responsible Party: Jingping Zhao, professor, Central South University
ClinicalTrials.gov Identifier: NCT01778244     History of Changes
Other Study ID Numbers: RRWu
First Posted: January 29, 2013    Key Record Dates
Last Update Posted: January 29, 2013
Last Verified: January 2013

Keywords provided by Jingping Zhao, Central South University:
schizophrenia; dyslipidemia

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Metformin
Antipsychotic Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs