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View Clinical Trial (Medical Research Study)
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Body Mass Index (BMI) and Metabolic Changes Following Switch to Aripiprazole From Olanzapine, Risperidone and Quetiapine - NCT00312598-27599 (Clinical Trial 140676)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy140676.aspx
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| City: |
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Chapel Hill |
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State:
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NC |
| Zip Code: |
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27599 |
| Conditions: |
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Schizophrenia - Schizoaffective Disorder - Schizophreniform Disorder - Mood Disorders |
| Purpose: |
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Weight gain is a serious, common side effect of many antipsychotic medications. On average,
the highest amounts of weight gain are found to occur in people taking clozaril and
olanzapine, but with significant weight gain occuring in those on the other atypical
antipsychotics as well.
We, the researchers at the University of North Carolina, propose an open-label pilot study
of the changes in weight, BMI, body composition, and lipids, glucose, insulin and other
metabolic parameters occurring in subjects as they switch from treatment with olanzapine,
risperidone or quetiapine to aripiprazole. We also will determine resting energy
expenditure (REE) and respiratory quotient (RQ) as measured by metabolic cart to determine
if either energy expenditure or the propensity to store energy as fat may be involved in any
changes to weight that are detected. Food intake, hunger, and physical activity will also
be assessed.
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| Study summary: |
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Weight gain is a serious, common side effect of many antipsychotic medications. It is a
frequent cause of poor adherence to antipsychotic medications and a major contributor to
medical problems including Syndrome X, various cancers, osteoarthritis and sleep apnea.
Syndrome X, also called the Metabolic Syndrome, is a constellation of abnormalities of
metabolism that confer a high risk of coronary heart disease. Syndrome X includes glucose
intolerance, dyslipidemia, hypertension, and central obesity. Long-term patients on
antipsychotic medications have markedly increased rates of Syndrome X that are consistent
with increased cardiovascular morbidity and decreased life expectancy.
A recent meta-analysis estimated weight gain at 10 weeks of treatment for a variety of
antipsychotics and found that clozapine had the highest average weight gain (4.45 kg),
followed by olanzapine (4.15 kg), quetiapine (2.2 kg), risperidone (2.18 kg), and
ziprasidone (0.04 kg) . For some drugs weight gain continues over many months, with the
time to plateau being directly related to the initial degree of weight gain. Early data for
the most recently approved antipsychotic, aripiprazole, shows it to be weight neutral but
the characteristics of its effects on weight are still to be determined. A recent
publication of 224 subjects switching by three different switching strategies from
haloperidol, thioridazine, risperidone or olanzapine to aripiprazole found weight loss of
between 1.3 and 1.7 kg after 8 weeks on aripiprazole. Cholesterol levels improved in
subjects switching from olanzapine to aripiprazole.
Atypical antipsychotic medications that can improve the factors associated with Syndrome X
could offer a very attractive alternative for patients who have already developed this
constellation of symptoms during treatment with other antipsychotics. It is not known if a
switch to aripiprazole from an atypical antipsychotic medication that has caused excessive
weight gain and/or abnormalities of glucose, lipids or blood pressure will result in
significant improvement in these factors or simply halt worsening. If worsening is only
halted, then switch from a weight-inducing drug to aripiprazole should be done early. If
factors associated with Syndrome X can be reversed, then switch to aripiprazole would be
very beneficial even after abnormalities have developed.
We propose an open-label pilot study of the changes in weight, BMI, body composition, and
lipids, glucose, insulin and other metabolic parameters occurring in subjects as they switch
from treatment with olanzapine, risperidone or quetiapine to aripiprazole. We also will
determine resting energy expenditure (REE) and respiratory quotient (RQ) as measured by
metabolic cart to determine if either energy expenditure or the propensity to store energy
as fat may be involved in any changes to weight that are detected. Food intake, hunger, and
physical activity will also be assessed.
Recruited subjects will enter a screening phase where patient eligibility is determined
through assessments of psychiatric and physical health, including physical examination,
blood tests and urine drug screen. Subjects not meeting eligibility criteria will be
discontinued.
Thirty subjects will be enrolled into this open label study. At entry into the study,
anthropometric measures (wt, ht, waist, hip), body composition, respiratory quotient (RQ),
resting energy expenditure (REE), and measures of food intake, hunger, and physical activity
will be assessed. Additionally, the Positive and Negative Symptom Scale (PANSS) will be
used to assess clinical status and all women will have a blood pregnancy test as required
prior to having a DXA scan. Following completion of these assessments, subjects will begin
a two week cross-taper from their current antipsychotic to aripiprazole. Psychiatric
symptoms, weight, medical status and medication query will be reassessed after 2, 4, 8 and
12 weeks. RQ and hunger will be reassessed at the 4 week time point. Fasting bloodwork,
pregnancy test, urine drug screen, vital signs, and all baseline assessments will be
repeated at the 12 week time point or at early termination. During the study, dosage of
aripiprazole will be tailored to each subject's need based on symptoms and side effects, and
will remain at or below the maximum recommended dosage. |
| Criteria: |
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Inclusion Criteria:
- Any ethnicity
- Antipsychotic monotherapy with olanzapine, risperidone or quetiapine for minimum of 1
month at entry into study and with weight gain of 2 BMI units while on this
medication or development of abnormalities of glucose (greater than 110 mg/dl
fasting), lipids (total cholesterol [TC], high-density lipoprotein [HDL],
triglycerides [TG], or low-density lipoprotein [LDL] greater than 10% change) or
blood pressure (greater than 20 mmHg change in systolic or diastolic)
- Antipsychotic monotherapy with aripiprazole is planned by the subject's treating
psychiatrist.
- Subjects able to fully participate in the informed consent process
- Female subjects of childbearing potential must be using a medically accepted means of
contraception which includes tubal ligation, hysterectomy, condoms, oral
contraceptives, intrauterine device (IUD), cervical cap, diaphragm, transdermal
contraceptive patch, and abstinence.
Exclusion Criteria:
- Subjects have had a previous trial of aripiprazole
- Serious or unstable medical illness which requires ongoing treatment with medication.
This does not include non-insulin dependent diabetes, dyslipidemia or hypertension.
- At serious suicidal risk.
- Subjects with substance abuse or dependence.
- Female subjects who are either pregnant or nursing.
- Known history of mental retardation |
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| Study is available at: |
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University of North Carolina at Chapel Hill
Chapel Hill, NC 27599
United States
Primary Contact:
Brenda Pearson, LCSW
Email: bpearson@med.unc.edu
Phone: 919-843-8084
Secondary Contact:
Brenda Pearson, LCSW
Email: bpearson@med.unc.edu
Phone: 919-843-8084 |
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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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February 15, 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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