Status:
WITHDRAWN
Efficacy and Safety of Metformin in Preventing Patients With Risperidone From Weight Gain and Amenorrhea
Lead Sponsor:
Central South University
Conditions:
Weight Gain
Amenorrhea
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
Some previous studies has demonstrated that Metformin can improve the weight gain which caused by antipsychotics. An our study, which will be published, also found that Metformin can improve the ameno...
Eligibility Criteria
Inclusion
- age 18-40 years.
- diagnosis of schizophrenia (naive first-episode) as defined in DSM-IV axis I.
- At screening, patients were required to have total score ≥60 on Positive and Negative Syndrome Scale (PANSS) and ≥4 on the Clinical Global Impression-severity scale (CGI-S).
- treat with Risperidone.
- Never participate in a diet control nor in other weight loss programs, and have a normal Period.
- Written informed consents could be obtained from patients(or their Legal guardian).
Exclusion
- Female patients, those who were in the period of pregnancy and lactation, or plan pregnancy, were excluded.
- Patients with serious physical disease patients, just like Epilepsy, liver and kidney dysfunction, diabetes, blood diseases, etc were excluded.
- At screening, patients with abnormal results in physical examination, laboratory test, or electrocardiogram (ECG) were excluded.
- Patients were also excluded if they met primary DSM-IV axis I psychiatric disorders other than schizophrenia, or ever used psychoactive substance.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01423487
Start Date
August 1 2011
End Date
August 1 2013
Last Update
August 2 2012
Active Locations (1)
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1
Mental Health Institute of The Second Xiangya Hospital
Changsha, Hunan, China, 410011