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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01423487
Other study ID # CSUXXEYYJYS-051
Secondary ID
Status Withdrawn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Status Withdrawn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


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
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