Metformin for Treatment Antipsychotic Induced Amenorrhea in Female Schizophrenic Patients

• Sponsor: Central South University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01206153
• Collaborator: (none)
• Enrollment: 84
• Location: 1
• Arm: 1
• Duration (Months): 21
• Patients Per Site Per Month: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Amenorrhea	Drug: metformin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Official Title: Metformin for Treatment Antipsychotic Induced Amenorrhea in Female Schizophrenic Patients: a Double Blind, Placebo-controlled Study
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: metformin	Drug: metformin

Outcome Measures

Primary Outcome Measures

1. prolactin level []

   the outcome measure assess a efficacy.

Secondary Outcome Measures

1. fasting glucose []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Mental Health of The Second Xiangya Hospital, Central South University	Changsha	Hunan	China	410011

Sponsors and Collaborators

• Central South University

Investigators

• Principal Investigator: 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01206153
• Other Study ID Numbers: RWu
• First Posted: Sep 21, 2010
• Last Update Posted: Sep 21, 2010
• Last Verified: Feb 1, 2008

• Additional relevant MeSH terms: Amenorrhea; Metformin

Study Results

No Results Posted as of Sep 21, 2010