NCT01206153

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2010

Completed
Last Updated

September 21, 2010

Status Verified

February 1, 2008

Enrollment Period

1.6 years

First QC Date

September 13, 2010

Last Update Submit

September 20, 2010

Conditions

Amenorrhea

Outcome Measures

Primary Outcomes (1)

  • prolactin level

    the outcome measure assess a efficacy.

Secondary Outcomes (1)

  • fasting glucose

Study Arms (1)

metformin

EXPERIMENTAL
Drug: metformin

Interventions

metforminDRUG
metformin

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Changsha, Hunan, 410011, China

Location

MeSH Terms

Conditions

Amenorrhea

Interventions

Metformin

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2010

First Posted

September 21, 2010

Study Start

June 1, 2008

Primary Completion

January 1, 2010

Study Completion

March 1, 2010

Last Updated

September 21, 2010

Record last verified: 2008-02

Locations

CN(1)