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

NCT ID: NCT01423487

Last Updated: 2012-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Weight Gain Amenorrhea

Keywords

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Metformin Risperidone Prevention weight gain Amenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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efficacy and safety

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

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

0.5g bid 26 weeks

placebo comparator

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

Group Type PLACEBO_COMPARATOR

Starch tablets

Intervention Type OTHER

0.5g bid 26 weeks

Interventions

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Metformin

0.5g bid 26 weeks

Intervention Type DRUG

Starch tablets

0.5g bid 26 weeks

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Central South University

OTHER

Sponsor Role lead

Responsible Party

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Jing-Ping Zhao

Professor,Deputy Director of Mental Health Institute of The Second Xiangya Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: STUDY_CHAIR

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

Locations

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Mental Health Institute of The Second Xiangya Hospital

Changsha, Hunan, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 18182600 (View on PubMed)

Other Identifiers

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CSUXXEYYJYS-051

Identifier Type: -

Identifier Source: org_study_id