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Metformin for Treatment Antipsychotic Induced Amenorrhea in Female Schizophrenic Patients

This study has been completed.
Sponsor:
Information provided by:
Central South University
ClinicalTrials.gov Identifier:
NCT01206153
First received: September 13, 2010
Last updated: September 20, 2010
Last verified: February 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Central South University:

Primary Outcome Measures:
  • prolactin level [ Designated as safety issue: No ]
    the outcome measure assess a efficacy.


Secondary Outcome Measures:
  • fasting glucose [ Designated as safety issue: Yes ]

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
Genders 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
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

No publications provided

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
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Amenorrhea
Menstruation Disturbances
Pathologic Processes
Metformin
Antipsychotic Agents
Hypoglycemic Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 19, 2013