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

Not Applicable

Withdrawn

• Conditions: Weight Gain; Amenorrhea
• Interventions: Other: Starch tablets; Drug: Metformin

• Registration Number: NCT01423487
• Lead Sponsor: Central South University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-18
• Study First Submitted QC: 2011-08-25
• Study First Posted: 2011-08-26
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-31
• Last Update Posted: 2012-08-02
• Primary Completion: 2013-02
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo comparator	Starch tablets	To investigate whether plcebo also could preventing patients with Risperidone from weight gain and amenorrhea.
efficacy and safety	Metformin	To investigate the efficacy and safety of Metformin in preventing patients with Risperidone from weight gain and amenorrhea.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in weight at 24 weeks	baseline, 8 week, 16 week, 24 week	The data will be presented

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in menstruation at 24 weeks	baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week	The data will be presented

Trial Locations

Locations (1)

Mental Health Institute of The Second Xiangya Hospital; 🇨🇳 Changsha, Hunan, China