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:

Drug Information available for: Metformin Metformin hydrochloride

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 (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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 Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs

ClinicalTrials.gov processed this record on September 28, 2016

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