Metformin for Treatment Antipsychotic-induced Metabolic Syndrome in Bipolar Disorder Patients
1 other identifier
interventional
110
1 country
1
Brief Summary
The purpose of this study is to test the efficacy of metformin for treatment antipsychotic-induced metabolic syndrome in bipolar disorder patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2012
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 29, 2015
CompletedFirst Posted
Study publicly available on registry
January 1, 2016
CompletedJanuary 1, 2016
December 1, 2015
3.3 years
December 29, 2015
December 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the percentage of patients who had metabolic syndrome
week 24
Secondary Outcomes (4)
body mass index
week 24
blood pressure
week 24
fasting glucose
week 24
lipid levels
week 24
Study Arms (2)
metformin group
EXPERIMENTALMetformin 1000mg/day
placebo group
PLACEBO COMPARATORstarch
Interventions
Eligibility Criteria
You may qualify if:
- clinical diagnosis of bipolar disorder
- have experienced metabolic syndrome as defined below within the first year of treatment with one of four antipsychotics-clozapine, olanzapine, risperidone, or sulpiride
- had been either discharged from inpatient units or first visit in the outpatient clinic in the 12 months before enrollment, and their glucose and lipid levels, weight, blood pressure and antipsychotic treatment were documented
- had taken single antipsychotic medication, with no more than a 25% change in dosage, over the past 3 months
- must be under the care of a parent or another adult caregiver who monitored and recorded the intake of medication daily during the trial to assure the adherence to medication
You may not qualify if:
- any psychiatric diagnosis other than schizophrenia
- liver dysfunction
- renal dysfunction
- cardiovascular disease
- diabetes mellitus
- pregnancy
- lactation period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychiatry, the First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of department of psychiatry
Study Record Dates
First Submitted
December 29, 2015
First Posted
January 1, 2016
Study Start
June 1, 2012
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
January 1, 2016
Record last verified: 2015-12