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CompletedNCT01206153Updated Sep 21, 2010

Metformin for Treatment Antipsychotic Induced Amenorrhea in Female Schizophrenic Patients

A Phase 4 interventional study of metformin in Amenorrhea, sponsored by Central South University. Completed at 1 site in China. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2010-09-21.

Sponsored by Central South University · Phase 4 and Interventional

Phase
Phase 4
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Amenorrhea

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03

In context

Amenorrhea

80 studies on the registry are indexed under Amenorrhea; 13 are open to participants now.

This study's enrollment of 84 is above the median of 60 across 43 interventional studies indexed under Amenorrhea.

Browse Amenorrhea studies →

Lead sponsor

Central South University is the lead sponsor of 126 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • liver or renal diseases
  • pregnant or lactating women
  • cardiovascular diseases
  • hypertension or diabetes mellitus
05

Study design

Phase
Phase 4
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
84 participants (actual)

Study arms

  • Experimental
    metformin

    Drug: metformin

Interventions

  • Drugmetformin
06

What researchers measure

Primary outcomes

  1. prolactin level

    the outcome measure assess a efficacy.

Secondary outcomes

  1. fasting glucose

07

Study locations

1 site
  • Institute of Mental Health of The Second Xiangya Hospital, Central South University
    Changsha, Hunan 410011, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01206153
Lead sponsor
Central South University
First posted
Sep 21, 2010
Start date
Jun 2008
Primary completion
Jan 2010
Completion
Mar 2010
Last update
Sep 21, 2010

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.

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