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

Primary Purpose

Weight Gain, Amenorrhea

Status

Withdrawn

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Metformin

Starch tablets

About this trial

This is an interventional prevention trial for Weight Gain focused on measuring Metformin, Risperidone, Prevention, weight gain, Amenorrhea

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

age 18-40 years.
diagnosis of schizophrenia (naive first-episode) as defined in DSM-IV axis I.
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).
treat with Risperidone.
Never participate in a diet control nor in other weight loss programs, and have a normal Period.
Written informed consents could be obtained from patients(or their Legal guardian).

Exclusion Criteria:

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

Sites / Locations

Mental Health Institute of The Second Xiangya Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

efficacy and safety

placebo comparator

Arm Description

To investigate the efficacy and safety of Metformin in preventing patients with Risperidone from weight gain and amenorrhea.

To investigate whether plcebo also could preventing patients with Risperidone from weight gain and amenorrhea.

Outcomes

Primary Outcome Measures

Change from Baseline in weight at 24 weeks

The data will be presented

Secondary Outcome Measures

Change from Baseline in menstruation at 24 weeks

The data will be presented

Full Information

NCT ID

NCT01423487

First Posted

August 18, 2011

Last Updated

July 31, 2012

Sponsor

Central South University

1. Study Identification

Unique Protocol Identification Number

NCT01423487

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Withdrawn

Why Stopped

Difficult to obtain informed consent

Study Start Date

August 2011 (undefined)

Primary Completion Date

February 2013 (Anticipated)

Study Completion Date

August 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Central South University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Weight Gain, Amenorrhea

Keywords

Metformin, Risperidone, Prevention, weight gain, Amenorrhea

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

efficacy and safety

Arm Type

Experimental

Arm Description

To investigate the efficacy and safety of Metformin in preventing patients with Risperidone from weight gain and amenorrhea.

Arm Title

placebo comparator

Arm Type

Placebo Comparator

Arm Description

To investigate whether plcebo also could preventing patients with Risperidone from weight gain and amenorrhea.

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

0.5g bid 26 weeks

Intervention Type

Other

Intervention Name(s)

Starch tablets

Intervention Description

0.5g bid 26 weeks

Primary Outcome Measure Information:

Title

Change from Baseline in weight at 24 weeks

Description

The data will be presented

Time Frame

baseline, 8 week, 16 week, 24 week

Secondary Outcome Measure Information:

Title

Change from Baseline in menstruation at 24 weeks

Description

The data will be presented

Time Frame

baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age 18-40 years. diagnosis of schizophrenia (naive first-episode) as defined in DSM-IV axis I. 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). treat with Risperidone. Never participate in a diet control nor in other weight loss programs, and have a normal Period. Written informed consents could be obtained from patients(or their Legal guardian). Exclusion Criteria: Female patients, those who were in the period of pregnancy and lactation, or plan pregnancy, were excluded. Patients with serious physical disease patients, just like Epilepsy, liver and kidney dysfunction, diabetes, blood diseases, etc were excluded. At screening, patients with abnormal results in physical examination, laboratory test, or electrocardiogram (ECG) were excluded. Patients were also excluded if they met primary DSM-IV axis I psychiatric disorders other than schizophrenia, or ever used psychoactive substance.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jing-Ping Zhao, Dr., Ph.D.

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

Mental Health Institute of The Second Xiangya Hospital

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410011

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

18182600

Citation

Wu RR, Zhao JP, Jin H, Shao P, Fang MS, Guo XF, He YQ, Liu YJ, Chen JD, Li LH. Lifestyle intervention and metformin for treatment of antipsychotic-induced weight gain: a randomized controlled trial. JAMA. 2008 Jan 9;299(2):185-93. doi: 10.1001/jama.2007.56-b.

Results Reference

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

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