Clinical Trial: Efficacy and Safety of Metformin in Preventing Patients With Risperidone From Weight Gain and Amenorrhea

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Efficacy and Safety of Metformin in Preventing Patients With Risperidone From Weight Gain and Amenorrhea:a 24-week, Randomized, Placebo-controlled, Double-blind, Fixed-dos

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 amenorrhea for patients with antipsychotics, approximately 60% patients recovery period. So the present study was designed to investigate the efficacy and safety of Metformin in preventing patients with Risperidone from weight gain and amenorrhea.

Detailed Summary:
Sponsor: Central South University

Current Primary Outcome: Change from Baseline in weight at 24 weeks [ Time Frame: baseline, 8 week, 16 week, 24 week ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Change from Baseline in menstruation at 24 weeks [ Time Frame: baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week ]

Original Secondary Outcome: Same as current

Information By: Central South University

Dates:
Date Received: August 18, 2011
Date Started: August 2011
Date Completion: August 2013
Last Updated: July 31, 2012
Last Verified: July 2012