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Metformin for Treatment Antipsychotic Induced Amenorrhea in Female Schizophrenic Patients

This study has been completed.
Information provided by:
Central South University Identifier:
First received: September 13, 2010
Last updated: September 20, 2010
Last verified: February 2008
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
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 level
    the 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


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 identifier: NCT01206153

China, Hunan
Institute of Mental Health of The Second Xiangya Hospital, Central South University
Changsha, Hunan, China, 410011
Sponsors and Collaborators
Central South University
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 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:
Menstruation Disturbances
Pathologic Processes
Antipsychotic Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs processed this record on May 24, 2017