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Metformin for Treatment Antipsychotic Induced Amenorrhea in Female Schizophrenic Patients

NCT ID: NCT01206153

Last Updated: 2010-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-03-31

Brief Summary

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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

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Conditions

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Amenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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metformin

Group Type EXPERIMENTAL

metformin

Intervention Type DRUG

Interventions

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metformin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Central South University

OTHER

Sponsor Role lead

Responsible Party

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the Second Xiangya Hospital of Central South University

Principal Investigators

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Jingping Zhao, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Mental Health of The Second Xiangya Hospital, Central South University, 139# Renmin Middle Road，Changsha 410011, Hunan, P.R. China

Locations

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Institute of Mental Health of The Second Xiangya Hospital, Central South University

Changsha, Hunan, China

Site Status

Countries

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China

Other Identifiers

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RWu

Identifier Type: -

Identifier Source: org_study_id