Metformin for Treatment of Antipsychotic-induced Dyslipidemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jingping Zhao, Central South University
ClinicalTrials.gov Identifier:
NCT01778244
First received: January 19, 2013
Last updated: January 25, 2013
Last verified: January 2013
  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.


Condition Intervention Phase
Dyslipidemia
Drug: metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Metformin for Treatment of Antipsychotic-induced Dyslipidemia: a Randomized, Double-blind Study

Resource links provided by NLM:


Further study details as provided by Central South University:

Primary Outcome Measures:
  • low-density lipoprotein cholesterol [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

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 ]

Other Outcome Measures:
  • body mass index [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 162
Study Start Date: November 2008
Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: metformin
metformin
Drug: metformin
1000mg/day for 24 weeks
Other Name: metformin
Placebo Comparator: placebo
placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Jingping Zhao, professor, Central South University
ClinicalTrials.gov Identifier: NCT01778244     History of Changes
Other Study ID Numbers: RRWu
Study First Received: January 19, 2013
Last Updated: January 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Central South University:
schizophrenia; dyslipidemia

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

ClinicalTrials.gov processed this record on October 19, 2014