NCT01778244

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
Last Updated

January 29, 2013

Status Verified

January 1, 2013

Enrollment Period

3.1 years

First QC Date

January 19, 2013

Last Update Submit

January 25, 2013

Conditions

Dyslipidemia

Keywords

schizophrenia; dyslipidemia

Outcome Measures

Primary Outcomes (1)

  • low-density lipoprotein cholesterol

    8 weeks

Secondary Outcomes (2)

  • high-density lipoprotein cholesterol

    8 weeks

  • adverse effects

    8 weeks

Other Outcomes (1)

  • body mass index

    8 weeks

Study Arms (2)

metformin

EXPERIMENTAL

metformin

Drug: metformin

placebo

PLACEBO COMPARATOR

placebo

Interventions

metforminDRUG

1000mg/day for 24 weeks

metformin

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Changsha, Hunan, 410011, China

Location

MeSH Terms

Conditions

DyslipidemiasSchizophrenia

Interventions

Metformin

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Renrong Wu, MD

    Second Xiangya Hospital of Central South University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 19, 2013

First Posted

January 29, 2013

Study Start

November 1, 2008

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

January 29, 2013

Record last verified: 2013-01

Locations

CN(1)