Efficacy and Safety of Metformin in Preventing Patients With Risperidone From Weight Gain and Amenorrhea

July 31, 2012 updated by: Jing-Ping Zhao, Central South University

Efficacy and Safety of Metformin in Preventing Patients With Risperidone From Weight Gain and Amenorrhea:a 24-week, Randomized, Placebo-controlled, Double-blind, Fixed-dose Study

Some previous studies has demonstrated that Metformin can improve the weight gain which caused by antipsychotics. An our study, which will be published, also found that Metformin can improve the amenorrhea for patients with antipsychotics, approximately 60% patients recovery period. So the present study was designed to investigate the efficacy and safety of Metformin in preventing patients with Risperidone from weight gain and amenorrhea.

Study Overview

Status

Withdrawn

Conditions

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hunan
      • Changsha, Hunan, China, 410011
        • Mental Health Institute of The Second Xiangya Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. age 18-40 years.
  2. diagnosis of schizophrenia (naive first-episode) as defined in DSM-IV axis I.
  3. At screening, patients were required to have total score ≥60 on Positive and Negative Syndrome Scale (PANSS) and ≥4 on the Clinical Global Impression-severity scale (CGI-S).
  4. treat with Risperidone.
  5. Never participate in a diet control nor in other weight loss programs, and have a normal Period.
  6. Written informed consents could be obtained from patients(or their Legal guardian).

Exclusion Criteria:

  1. Female patients, those who were in the period of pregnancy and lactation, or plan pregnancy, were excluded.
  2. Patients with serious physical disease patients, just like Epilepsy, liver and kidney dysfunction, diabetes, blood diseases, etc were excluded.
  3. At screening, patients with abnormal results in physical examination, laboratory test, or electrocardiogram (ECG) were excluded.
  4. Patients were also excluded if they met primary DSM-IV axis I psychiatric disorders other than schizophrenia, or ever used psychoactive substance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: efficacy and safety
To investigate the efficacy and safety of Metformin in preventing patients with Risperidone from weight gain and amenorrhea.
0.5g bid 26 weeks
Placebo Comparator: placebo comparator
To investigate whether plcebo also could preventing patients with Risperidone from weight gain and amenorrhea.
0.5g bid 26 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in weight at 24 weeks
Time Frame: baseline, 8 week, 16 week, 24 week
The data will be presented
baseline, 8 week, 16 week, 24 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in menstruation at 24 weeks
Time Frame: baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week
The data will be presented
baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Jing-Ping Zhao, Dr., Ph.D., Mental Health Institute of The Second Xiangya Hospital, Central South University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Anticipated)

February 1, 2013

Study Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

August 18, 2011

First Submitted That Met QC Criteria

August 25, 2011

First Posted (Estimate)

August 26, 2011

Study Record Updates

Last Update Posted (Estimate)

August 2, 2012

Last Update Submitted That Met QC Criteria

July 31, 2012

Last Verified

July 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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