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

Study Overview
=================
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.

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-dose Study

Conditions
-----------------
Weight Gain, Amenorrhea

Intervention / Treatment
-----------------
* Drug: Metformin
* Other: Starch tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: efficacy and safety<br>To investigate the efficacy and safety of Metformin in preventing patients with Risperidone from weight gain and amenorrhea. | Drug: Metformin<br>* 0.5g bid 26 weeks<br>|
| Placebo Comparator: placebo comparator<br>To investigate whether plcebo also could preventing patients with Risperidone from weight gain and amenorrhea. | Other: Starch tablets<br>* 0.5g bid 26 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in weight at 24 weeks | The data will be presented | baseline, 8 week, 16 week, 24 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in menstruation at 24 weeks | The data will be presented | baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metformin, Risperidone, Prevention, weight gain, Amenorrhea