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View Clinical Trial (Medical Research Study)
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Exenatide for the Treatment of Weight Gain Associated With Olanzapine in Obese Adults With Bipolar Disorder - NCT00845507-45219 (Clinical Trial 272402)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy272402.aspx
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| City: |
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Cincinnati |
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State:
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OH |
| Zip Code: |
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45219 |
| Conditions: |
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Weight Gain |
| Purpose: |
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The purpose of this research study is to test the safety and efficacy (how well it works) of
exenatide as a treatment for weight gain associated with olanzapine in obese adults with
bipolar disorder.
Exenatide has been approved by the FDA for the treatment of Type 2 diabetes. It has not
been approved for the treatment of weight gain associated with olanzapine in obese adults
with bipolar disorder.
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| Study summary: |
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Double-blind studies suggest that olanzapine is highly effective for the treatment of
individuals with bipolar disorder. However, weight gain and impaired glucose tolerance
remain significant concerns associated with olanzapine. Exenatide is an anti-diabetic
medication that is associated with weight loss and improved glucose regulation. Therefore,
the overall goal of the proposed study is to conduct a 16-week double-blind
placebo-controlled study of exenatide for the treatment of weight gain associated with
olanzapine in 60 obese adults with bipolar disorder treated with olanzapine. We propose to
conduct the study over the course of 24 months, with an expected enrollment of approximately
3 patients per month. The primary outcome measure will be change from baseline to endpoint
in weight. The secondary outcome measures will include changes from baseline to endpoint, in
body mass index (BMI), abdominal circumference, metabolic parameters, clinical global
improvement of psychiatric symptoms, and change in manic, depressive and psychotic symptoms.
Rates of adverse events also will be assessed. |
| Criteria: |
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Inclusion Criteria:
1. Subjects must be between the ages of 18 and 55 years old.
2. Subjects must have bipolar I disorder, as defined by DSM-IV-TR criteria and diagnosed
using the Structured Clinical Interview for DSM-IV (SCID).
3. Subjects must have a Young Mania Rating Scale (YMRS) score < 16 and a
Montgomery-Asberg Depression Rating Scale (MADRS) score < 24 at screening and
baseline visits.
4. Subjects must have gained > 7% of their body weight following treatment with
olanzapine as either documented in their medical records or by patient report.
5. Subjects must be obese, as defined by a current Body Mass Index (BMI) > 30 kg/m2.
6. Subjects must sign the Informed Consent Document after the nature of the trial has
been fully explained.
7. If female, subjects must be: postmenopausal, surgically incapable of childbearing, or
practicing medically acceptable method(s) of contraception (e.g., hormonal methods,
intrauterine device, abstinence) for at least one month prior to study entry and
throughout the study.
8. Subjects must be on a stable dose of olanzapine for at least 14 days and must have
been on 5-30mg/day for at least 1 month.
Exclusion Criteria
1. Subjects with clinically significant suicidal or homicidal ideation.
2. Subjects who have a DSM-IV lifetime diagnosis of a substance dependence disorder or
within the past month have been diagnosed with a substance abuse disorder, (except
for nicotine abuse or dependence), as determined by psychiatric history or SCID
interview.
3. Subjects with a clinically significant or unstable medical disease, including
hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic,
immunologic, hematologic or other systemic medical conditions, that could interfere
with diagnosis, assessment, or treatment of bipolar disorder or obesity, as well as
subjects with a history of pancreatitis.
4. Patients with clinically significant laboratory abnormalities (> 3 times upper limit
of normal), on any of the following tests: CBC with differential, electrolytes, BUN,
creatinine, hepatic transaminases, lipid profile, fasting glucose, urinalysis, or
thyroid indices or clinically abnormal ECG.
5. Female patients who are either pregnant or lactating.
6. Any female patient whose sexual activity is unknown or in questions.
7. Any history of current or past diabetes that has been treated with pharmacological
intervention. Subjects who have a diagnosis of diabetes, are currently receiving
exenatide, insulin, or an oral anti-hyperglycemic medication, or who have a
nonfasting blood glucose ≥ 200 mg/dl or a fasting blood glucose ≥126 mg/dl on 2
separate tests. Subjects with pre-diabetes will not be excluded.
8. Neurological disorders including epilepsy, stroke, or severe head trauma.
9. Mental retardation (IQ <70).
10. Treatment with an injectable depot neuroleptic within less than one dosing interval
between depot neuroleptic injections and day 0.
11. Treatment with concurrent mood stabilizers or anticonvulsants, antipsychotics,
benzodiazepines, psychostimulants or antidepressants.
12. Schizophrenia or other psychotic disorders (including schizophreniform disorder,
schizoaffective disorder, delusional disorder, brief psychotic disorder, psychotic
disorder due to a general medical condition, substance-induced psychotic disorder,
psychotic disorder not otherwise specified) as defined in the DSM-IV.
13. Major depressive disorder, dysthymic disorder, depressive disorder not otherwise
specified.
14. Subjects previously enrolled in this study or have previously been treated with
exenatide.
15. Subjects who have received an experimental drug within 30 days.
16. Subjects who are displaying current clinically significant depressive or manic
symptoms, defined as a MADRS score >24 or a YMRS score > 16 or who currently meet
DSM-IV-TR criteria for a manic, mixed, hypomanic, or depressive episode associated
with bipolar disorder.
17. Subjects with a history of pancreatitis in themselves or any risk factors for
developing pancreatitis (risk factors include but are not limited to: alcohol use,
history of gallbladder disease or gallstones, diabetes or a family history of
pancreatitis)
18. Subjects with elevated amylase or lipase levels as measured at the screening visit |
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| Study is available at: |
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University of Cincinnati
Cincinnati, OH 45219
United States
Primary Contact:
Joy Leyland
Email: joy.leyland@uc.edu
Phone: 513-558-3674
Secondary Contact:
Joy Leyland
Email: joy.leyland@uc.edu
Phone: 513-558-3674 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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