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Metformin for Treatment of Antipsychotic-induced Dyslipidemia

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
metformin
Sponsored by
Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia focused on measuring schizophrenia; dyslipidemia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Mental Health of The Second Xiangya Hospital, Central South University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

metformin

placebo

Arm Description

metformin

placebo

Outcomes

Primary Outcome Measures

low-density lipoprotein cholesterol

Secondary Outcome Measures

high-density lipoprotein cholesterol
adverse effects

Full Information

First Posted
January 19, 2013
Last Updated
January 25, 2013
Sponsor
Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT01778244
Brief Title
Metformin for Treatment of Antipsychotic-induced Dyslipidemia
Official Title
Metformin for Treatment of Antipsychotic-induced Dyslipidemia: a Randomized, Double-blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
Keywords
schizophrenia; dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
metformin
Arm Type
Experimental
Arm Description
metformin
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
1000mg/day for 24 weeks
Primary Outcome Measure Information:
Title
low-density lipoprotein cholesterol
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
high-density lipoprotein cholesterol
Time Frame
8 weeks
Title
adverse effects
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
body mass index
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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. - Exclusion Criteria: liver or renal diseases pregnant or lactating women cardiovascular diseases hypertension or diabetes mellitus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renrong Wu, MD
Organizational Affiliation
Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Mental Health of The Second Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China

12. IPD Sharing Statement

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Metformin for Treatment of Antipsychotic-induced Dyslipidemia

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