Status:
WITHDRAWN
Prevention of Weight Gain and Dyslipidemia by Green Tea in Patients Initiating Therapy With Olanzapine
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Bipolar Disorder
Schizophrenia
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The purpose of this study is to determine if taking green tea capsules can help prevent weight gain in patients that start therapy with Zyprexa® (olanzapine).
Detailed Description
Atypical antipsychotic (AA) medications are associated with obesity, diabetes mellitus, dyslipidemia, and cardiovascular disease.1 The prevalence of obesity in the AA medicated population ranges from ...
Eligibility Criteria
Inclusion
- Concurrently taking Zyprexa® for a psychiatric indication such as bipolar disorder or schizophrenia
- Stable body weight (+ 5%) for at least 2 weeks prior to baseline visit
- No weight loss program participation within past 3 months
Exclusion
- Treatment with an atypical Anti-psychotic treatment other than olanzapine with the past 6 months
- BMI \> 40 kg/m2
- Use of any dietary supplements related to weight gain or weight loss within past 1 month
- Use of any medication related to weight or plasma lipid concentration (other than hormonal contraceptives). This includes, but not limited to: antihypertensives, benzodiazepines statins, and psychostimulants.
- Uncontrolled hypertension (SBP \>140 or DBP \> 90 mmHg)
- Use of a hypertensive medication
- Known active alcohol or substance abuse or consumption of \> three alcoholic beverages/day.
- Active cardiovascular disease
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00934908
Start Date
March 1 2009
End Date
March 1 2009
Last Update
July 18 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425