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Trial record 37 of 69 for:    "Bipolar Disorder" | "Olanzapine"

Prevention of Weight Gain and Dyslipidemia by Green Tea in Patients Initiating Therapy With Olanzapine

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ClinicalTrials.gov Identifier: NCT00934908
Recruitment Status : Withdrawn
First Posted : July 8, 2009
Last Update Posted : July 18, 2018
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Medical University of South Carolina

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).

Condition or disease Intervention/treatment Phase
Bipolar Disorder Schizophrenia Dietary Supplement: Green Tea Other: Placebo Not Applicable

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 40-60%, compared to 30% of the general population. Treatments that are aimed at either reducing the burden of obesity in psychotic illness or preventing the weight gain and other metabolic changes associated with AA are needed. One potential therapy that has received inadequate clinical evaluation is Green tea (Camillia sinensis; GT). GT contains flavonoids including epigallocatechin gallate (EGCG), as well as caffeine, that have been documented to promote weight and fat loss in normal to overweight healthy subjects. Recently green tea was shown to significantly decrease plasma LDL and triglyceride concentrations and increase HDL concentrations in obese women. GT has never been evaluated for its potential to prevent weight gain or changes in plasma lipid concentrations in patients initiating therapy with AA. However, case reports of individuals indicate that treatment with a green tea extract may have efficacy in preventing weight gain in 4 patients that initiated treatment with quetiapine.

We hypothesize that intake of GT in the form of a dietary supplement will result in significantly less weight gain than supplementation with placebo in patients initiating therapy with Zyprexa®. We propose to conduct an 12-week double-blind, placebo-controlled pilot study of 48 out-patient volunteers to determine if twice daily supplementation with GT 1) attenuates weight and fat gain in patients initiating therapy with Zyprexa® and 2) attenuates changes in cardiovascular risk factors including plasma lipoprotein and triglyceride concentrations. The experiments will be performed on patients who initiate therapy with Zyprexa® with a BMI < 40kg/m2 that do not have dyslipidemia requiring pharmacologic intervention.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Prevention of Weight Gain and Dyslipidemia by Green Tea in Patients Initiating Therapy With Olanzapine
Actual Study Start Date : March 2009
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Placebo Comparator: 1
Non-active "sugar pill"
Other: Placebo
Non-active "sugar pill".

Active Comparator: 2
Green Tea Capsules
Dietary Supplement: Green Tea
Green tea capsules taken twice a day.




Primary Outcome Measures :
  1. Attenuation of weight and fat gain in patients initiating therapy with Zyprexa® [ Time Frame: Weeks 1, 6 and 12 ]

Secondary Outcome Measures :
  1. Attenuation of negative changes in the plasma lipid profile in patients initiating therapy with Zyprexa®. [ Time Frame: Weeks 1, 6 and 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00934908


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Eli Lilly and Company
Investigators
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Principal Investigator: Jennifer L Donovan, PhD Medical University of South Carolina
Study Chair: Thomas W Uhde, MD Medical University of South Carolina

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00934908     History of Changes
Other Study ID Numbers: Green Tea and Olanzapine
First Posted: July 8, 2009    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2009
Keywords provided by Medical University of South Carolina:
Zyprexa®
Green Tea
ALL
Additional relevant MeSH terms:
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Bipolar Disorder
Olanzapine
Dyslipidemias
Weight Gain
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders
Lipid Metabolism Disorders
Metabolic Diseases
Body Weight Changes
Body Weight
Signs and Symptoms
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents