Metformin for Treatment Antipsychotic Induced Amenorrhea in Female Schizophrenic Patients
Overview[ - collapse ][ - ]
| Purpose | Antipsychotics such as risperidone could induce amenorrhea in schizophrenic patients. The investigators conducted a randomized, placebo-controlled study to test the efficacy of metformin for antipsychotic induced amenorrhea in schizophrenia patients. |
|---|---|
| Condition | Amenorrhea |
| Intervention | Drug: metformin |
| Phase | Phase 4 |
| Sponsor | Central South University |
| Responsible Party | Central South University |
| ClinicalTrials.gov Identifier | NCT01206153 |
| First Received | September 13, 2010 |
| Last Updated | September 20, 2010 |
| Last verified | February 2008 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 13, 2010 |
|---|---|
| Last Updated Date | September 20, 2010 |
| Start Date | June 2008 |
| Estimated Primary Completion Date | March 2010 |
| Current Primary Outcome Measures | prolactin level [Designated as safety issue: No]the outcome measure assess a efficacy. |
| Current Secondary Outcome Measures | fasting glucose [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Metformin for Treatment Antipsychotic Induced Amenorrhea in Female Schizophrenic Patients |
|---|---|
| Official Title | Metformin for Treatment Antipsychotic Induced Amenorrhea in Female Schizophrenic Patients: a Double Blind, Placebo-controlled Study |
| Brief Summary | Antipsychotics such as risperidone could induce amenorrhea in schizophrenic patients. The investigators conducted a randomized, placebo-controlled study to test the efficacy of metformin for antipsychotic induced amenorrhea in schizophrenia patients. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
| Condition | Amenorrhea |
| Intervention | Drug: metformin |
| Study Arm (s) | Experimental: metformin |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 84 |
| Estimated Completion Date | March 2010 |
| Estimated Primary Completion Date | January 2010 |
| Eligibility Criteria | Inclusion Criteria: - schizophrenia patient - amenorrhea for more than three months after antipsychotic treatment Exclusion Criteria: - liver or renal diseases - pregnant or lactating women - cardiovascular diseases - hypertension or diabetes mellitus |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | China |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01206153 |
|---|---|
| Other Study ID Numbers | RWu |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Central South University |
| Study Sponsor | Central South University |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Jingping Zhao, MD Institute of Mental Health of The Second Xiangya Hospital, Central South University, 139# Renmin Middle Road，Changsha 410011, Hunan, P.R. China |
| Verification Date | February 2008 |
Locations[ + expand ][ + ]
| Institute of Mental Health of The Second Xiangya Hospital, Central South University | Changsha, Hunan, China, 410011 |
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