Metformin for Treatment Antipsychotic Induced Amenorrhea in Female Schizophrenic Patients

Metformin for Treatment Antipsychotic Induced Amenorrhea in Female Schizophrenic Patients: a Double Blind, Placebo-controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Amenorrhea
• Intervention / Treatment: Drug: metformin

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410011
      • Institute of Mental Health of The Second Xiangya Hospital, Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: metformin	Drug: metformin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description
prolactin level	the outcome measure assess a efficacy.

Secondary Outcome Measures

Outcome Measure
fasting glucose

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: September 13, 2010
• First Submitted That Met QC Criteria: September 20, 2010
• First Posted (Estimate): September 21, 2010

Study Record Updates

• Last Update Posted (Estimate): September 21, 2010
• Last Update Submitted That Met QC Criteria: September 20, 2010
• Last Verified: February 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Menstruation Disturbances; Amenorrhea; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: RWu