Metformin for Treatment Antipsychotic Induced Amenorrhea in Female Schizophrenic Patients

Amenorrhea Clinical Trial

Official title:

Metformin for Treatment Antipsychotic Induced Amenorrhea in Female Schizophrenic Patients: a Double Blind, Placebo-controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01206153
• Other study ID #: RWu
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2010
• Last updated: September 20, 2010
• Start date: June 2008
• Est. completion date: March 2010

Study information

• Verified date: February 2008
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Amenorrhea

Intervention

Drug:
• metformin

Locations

Country	Name	City	State
China	Institute of Mental Health of The Second Xiangya Hospital, Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prolactin level	the outcome measure assess a efficacy.		No
Secondary	fasting glucose			Yes