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Metformin for Treatment Antipsychotic Induced Amenorrhea in Female Schizophrenic Patients
This study has been completed.
Sponsor:
Central South University
Information provided by:
Central South University
ClinicalTrials.gov Identifier:
NCT01206153
First received: September 13, 2010
Last updated: September 20, 2010
Last verified: February 2008
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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 | Intervention | Phase |
|---|---|---|
| Amenorrhea | Drug: metformin | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Official Title: | Metformin for Treatment Antipsychotic Induced Amenorrhea in Female Schizophrenic Patients: a Double Blind, Placebo-controlled Study |
Resource links provided by NLM:
Further study details as provided by Central South University:
Primary Outcome Measures:
- prolactin levelthe outcome measure assess a efficacy.
Secondary Outcome Measures:
- fasting glucose
| Enrollment: | 84 |
| Study Start Date: | June 2008 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: metformin | Drug: metformin |
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01206153
Please refer to this study by its ClinicalTrials.gov identifier: NCT01206153
Locations
| China, Hunan | |
| Institute of Mental Health of The Second Xiangya Hospital, Central South University | |
| Changsha, Hunan, China, 410011 | |
Sponsors and Collaborators
Central South University
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 |
More Information
| Responsible Party: | Jingping Zhao, the Second Xiangya Hospital of Central South University |
| ClinicalTrials.gov Identifier: | NCT01206153 History of Changes |
| Other Study ID Numbers: |
RWu |
| Study First Received: | September 13, 2010 |
| Last Updated: | September 20, 2010 |
Additional relevant MeSH terms:
|
Amenorrhea Menstruation Disturbances Pathologic Processes Metformin Antipsychotic Agents |
Hypoglycemic Agents Physiological Effects of Drugs Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |
ClinicalTrials.gov processed this record on June 22, 2017