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Metformin for Treatment Antipsychotic Induced Amenorrhea in Female Schizophrenic Patients

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ClinicalTrials.gov Identifier: NCT01206153
Recruitment Status : Completed
First Posted : September 21, 2010
Last Update Posted : September 21, 2010
Sponsor:
Information provided by:
Central South University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Amenorrhea Drug: metformin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Metformin for Treatment Antipsychotic Induced Amenorrhea in Female Schizophrenic Patients: a Double Blind, Placebo-controlled Study
Study Start Date : June 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : March 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: metformin Drug: metformin


Outcome Measures
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Primary Outcome Measures :
  1. prolactin level
    the outcome measure assess a efficacy.


Secondary Outcome Measures :
  1. fasting glucose

Eligibility Criteria
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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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Responsible Party: Jingping Zhao, the Second Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT01206153     History of Changes
Other Study ID Numbers: RWu
First Posted: September 21, 2010    Key Record Dates
Last Update Posted: September 21, 2010
Last Verified: February 2008

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