Metformin for Treatment Antipsychotic Induced Amenorrhea in Female Schizophrenic Patients

Phase 4

Completed

• Conditions: Amenorrhea
• Interventions: Drug: metformin

• Registration Number: NCT01206153
• Lead Sponsor: Central South University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2008-02
• Study Start: 2008-06
• Primary Completion: 2010-01
• Study Completion: 2010-03
• Study First Submitted: 2010-09-13
• Study First Submitted QC: 2010-09-20
• Last Update Submitted: 2010-09-20
• Study First Posted: 2010-09-21
• Last Update Posted: 2010-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

• schizophrenia patient
• amenorrhea for more than three months after antipsychotic treatment

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Exclusion Criteria

• liver or renal diseases
• pregnant or lactating women
• cardiovascular diseases
• hypertension or diabetes mellitus

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metformin	metformin	-

Primary Outcome Measures

Name	Time	Method
prolactin level		the outcome measure assess a efficacy.

Secondary Outcome Measures

Name	Time	Method
fasting glucose

Trial Locations

Locations (1)

Institute of Mental Health of The Second Xiangya Hospital, Central South University; 🇨🇳 Changsha, Hunan, China