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
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 |
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.
Status | Withdrawn |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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
China | Mental Health Institute of The Second Xiangya Hospital | Changsha | Hunan |
Lead Sponsor | Collaborator |
---|---|
Central South University |
China,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03249896 -
Web/Smartphone-based Lifestyle Coaching Program in Pregnant Women With Gestational Diabetes
|
N/A | |
Recruiting |
NCT04043520 -
Bioenergetic Effects of Aging and Menopause (BEAM)
|
Phase 4 | |
Completed |
NCT05508750 -
Growth and Safety Clinical Trial on a New Infant Formula
|
N/A | |
Not yet recruiting |
NCT03225456 -
Oxytocin and Eating
|
Phase 2 | |
Completed |
NCT02227043 -
Study Of Weight Development Over Time
|
N/A | |
Completed |
NCT01958307 -
Healthy Living in Pregnancy
|
N/A | |
Not yet recruiting |
NCT01916603 -
Diet, Physical Activity and Breastfeeding Intervention on Maternal Nutrition, Offspring Growth and Development
|
N/A | |
Completed |
NCT01693666 -
Lifestyle Intervention Forever: Healthy Weight for Pregnancy and Birth (Pilot Study)
|
N/A | |
Completed |
NCT01461824 -
Drug Exposure and Depot Medroxyprogesterone Acetate (DMPA) in Adolescent Subjects
|
Phase 3 | |
Terminated |
NCT00759993 -
Chromium Piccolinate in the Prevention of Weight Gain Induced by Serotonergic Medications Initiated on Psychiatric Inpatient Units.
|
Phase 2 | |
Completed |
NCT00634530 -
Impact of a Nutritional Intervention Program for Weight Control During Pregnancy
|
N/A | |
Completed |
NCT00995462 -
Prevention of Weight Gain in University Students
|
N/A | |
Completed |
NCT00122213 -
A Physical Activity and Diet Program to Prevent Accumulation of Abdominal Fat Mass in Recently Retired Men and Women
|
Phase 2 | |
Completed |
NCT00306449 -
Prevention of Weight Gain in Young Adults
|
N/A | |
Completed |
NCT03996551 -
ExeRTiOn2- The Weight Gain Prevention Exercise in Renal Transplant Online Study
|
N/A | |
Recruiting |
NCT03675464 -
Study of Human Adipose Tissue (LOSHAT)
|
||
Completed |
NCT04282655 -
Effect of Milk Warming on the Very Low Birth Weight Infant
|
N/A | |
Recruiting |
NCT05992688 -
The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time)
|
N/A | |
Completed |
NCT04069351 -
Body Composition Changes During Overfeeding Plus Resistance Training
|
N/A | |
Completed |
NCT00687115 -
Predicting Weight Gain and Weight Loss Associated With Overeating or Fasting
|
Phase 2 |