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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| efficacy and safety | Experimental | To investigate the efficacy and safety of Metformin in preventing patients with Risperidone from weight gain and amenorrhea. |
|
| placebo comparator | Placebo Comparator | To investigate whether plcebo also could preventing patients with Risperidone from weight gain and amenorrhea. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | 0.5g bid 26 weeks |
| |
| Starch tablets |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in weight at 24 weeks | The data will be presented | baseline, 8 week, 16 week, 24 week |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jing-Ping Zhao, Dr., Ph.D. | Mental Health Institute of The Second Xiangya Hospital, Central South University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mental Health Institute of The Second Xiangya Hospital | Changsha | Hunan | 410011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18182600 | Background | Wu RR, Zhao JP, Jin H, Shao P, Fang MS, Guo XF, He YQ, Liu YJ, Chen JD, Li LH. Lifestyle intervention and metformin for treatment of antipsychotic-induced weight gain: a randomized controlled trial. JAMA. 2008 Jan 9;299(2):185-93. doi: 10.1001/jama.2007.56-b. |
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| ID | Term |
|---|---|
| D015430 | Weight Gain |
| D000568 | Amenorrhea |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D013213 | Starch |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D005936 |
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| Other |
0.5g bid 26 weeks |
|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |