Efficacy and Safety of Metformin in Preventing Patients With Risperidone From Weight Gain and Amenorrhea
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Weight Gain Amenorrhea |
| Intervention | Drug: Metformin Other: Starch tablets |
| Phase | N/A |
| Sponsor | Central South University |
| Responsible Party | Central South University |
| ClinicalTrials.gov Identifier | NCT01423487 |
| First Received | August 18, 2011 |
| Last Updated | July 31, 2012 |
| Last verified | July 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 18, 2011 |
|---|---|
| Last Updated Date | July 31, 2012 |
| Start Date | August 2011 |
| Estimated Primary Completion Date | August 2013 |
| Current Primary Outcome Measures | Change from Baseline in weight at 24 weeks [Time Frame: baseline, 8 week, 16 week, 24 week] [Designated as safety issue: No]The data will be presented |
| Current Secondary Outcome Measures | Change from Baseline in menstruation at 24 weeks [Time Frame: baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week] [Designated as safety issue: No]The data will be presented |
Descriptive Information[ + expand ][ + ]
| Brief Title | 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 |
| 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 Description | Not Provided |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention |
| Condition |
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| Intervention | Drug: Metformin 0.5g bid 26 weeks Other: Starch tablets 0.5g bid 26 weeks |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Withdrawn |
|---|---|
| Estimated Enrollment | Not Provided |
| Estimated Completion Date | August 2013 |
| Estimated Primary Completion Date | February 2013 |
| Eligibility Criteria | Inclusion Criteria: 1. age 18-40 years. 2. diagnosis of schizophrenia (naive first-episode) as defined in DSM-IV axis I. 3. 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). 4. treat with Risperidone. 5. Never participate in a diet control nor in other weight loss programs, and have a normal Period. 6. Written informed consents could be obtained from patients(or their Legal guardian). Exclusion Criteria: 1. Female patients, those who were in the period of pregnancy and lactation, or plan pregnancy, were excluded. 2. Patients with serious physical disease patients, just like Epilepsy, liver and kidney dysfunction, diabetes, blood diseases, etc were excluded. 3. At screening, patients with abnormal results in physical examination, laboratory test, or electrocardiogram (ECG) were excluded. 4. Patients were also excluded if they met primary DSM-IV axis I psychiatric disorders other than schizophrenia, or ever used psychoactive substance. |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | China |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01423487 |
|---|---|
| Other Study ID Numbers | CSUXXEYYJYS-051 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Central South University |
| Study Sponsor | Central South University |
| Collaborators | Not Provided |
| Investigators | Study Chair: Jing-Ping Zhao, Dr., Ph.D. Mental Health Institute of The Second Xiangya Hospital, Central South University |
| Verification Date | July 2012 |
Locations[ + expand ][ + ]
| Mental Health Institute of The Second Xiangya Hospital | Changsha, Hunan, China, 410011 |
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