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

Weight Gain Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01423487
• Other study ID #: CSUXXEYYJYS-051
• Status: Withdrawn
• Phase: N/A
• First received: August 18, 2011
• Last updated: July 31, 2012
• Start date: August 2011
• Est. completion date: August 2013

Study information

• Verified date: July 2012
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Amenorrhea
• Body Weight
• Weight Gain

Intervention

Drug:
• Metformin
0.5g bid 26 weeks

Other:
• Starch tablets
0.5g bid 26 weeks

Locations

Country	Name	City	State
China	Mental Health Institute of The Second Xiangya Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in weight at 24 weeks	The data will be presented	baseline, 8 week, 16 week, 24 week	No
Secondary	Change from Baseline in menstruation at 24 weeks	The data will be presented	baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week	No