Metformin for Treatment Antipsychotic Induced Amenorrhea... | NCT01206153

Studies
Metformin for Treatment Antipsychotic Induced Amenorrhea in Female Schizophrenic Patients

NCT01206153

Sponsor

Central South University

Status

Completed

Last Update Posted

Sep 21, 2010Estimated

Enrollment

84Actual

Phase

Phase 4

Conditions

Amenorrhea

Interventions

metformin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Jan 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Sep 13, 2010

First Submission Date that Met QC Criteria

Sep 20, 2010

First Posted Date

Sep 21, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2010

Last Update Posted Date

Sep 21, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

84Actual

Label	Type	Description	Intervention Names
metformin	Experimental		Drug: metformin

Name	Type	Description	Arm Group Labels	Other Names
metformin	Drug		metformin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
prolactin level	the outcome measure assess a efficacy.

Secondary Outcomes

Measure	Description	Time Frame
fasting glucose

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Mental Health of The Second Xiangya Hospital, Central South University		Changsha	Hunan	410011	China

Condition Browse Module

MeSH Terms

ID	Term
D000568	Amenorrhea

Ancestor Terms

ID	Term
D008599	Menstruation Disturbances
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008687	Metformin

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided