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View Clinical Trial (Medical Research Study)
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Addition of Ondansetron to Ongoing Antipsychotic Treatment for Schizophrenia - NCT00149734-80220 (Clinical Trial 128139)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy128139.aspx
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| City: |
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Denver |
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State:
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CO |
| Zip Code: |
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80220 |
| Conditions: |
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Schizophrenia |
| Purpose: |
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This study will examine the effects of ondansetron on auditory nerve activity in people with
schizophrenia who are being treated with new antipsychotics.
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| Study summary: |
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Schizophrenia is a devastating brain disorder. Most people with schizophrenia have
difficulty filtering out unimportant auditory information. They have an inability to
appropriately inhibit, or gate, sensory information that enters the ear. Standard treatments
do not address this problem. When the drug ondansetron is taken in addition to typical
antipsychotic drugs, P50 auditory gating improves. However, ondansetron has not been used
with some of the newer, atypical antipsychotic drugs. This study will evaluate the effect of
combining ondansetron with newer, atypical antipsychotic drugs on P50 auditory gating.
Participants in this double-blind study will be randomly assigned to receive either
ondansetron or placebo for 3 months. Upon completion of the first 3 months, participants
will be crossed over to receive the other treatment for an additional 3 months. All
participants will also take an atypical antipsychotic drug, including olanzapine,
quetiapine, or aripiprazole. Auditory gating will be assessed using computerized cognitive
testing and functional magnetic resonance imaging (fMRI) at baseline and Months 3 and 6.
Vital signs and evoked potentials will be assessed at Weeks 1, 3, and 6. Clinical symptoms
and cognitive abilities will also be evaluated to determine the effectiveness of
ondansetron. |
| Criteria: |
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Inclusion Criteria:
- Meets DSM-IV criteria for schizophrenia
- Stable, chronic schizophrenia
- Currently taking atypical medications
- Use of effective form of contraception throughout study
Exclusion Criteria:
- History of any alcohol or drug abuse within 3 months of study start date
- Any other major neurological disorders
- History of or current head trauma
- Any medical conditions affecting the central nervous system
- Current epilepsy, asthma, migraine headache, previous myocardial infarction, stroke,
diabetes, hypertension, narrow angle glaucoma, or neuromuscular illnesses
- Pregnant |
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| Study is available at: |
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Denver VAMC
Denver, CO 80220
United States
Primary Contact:
Merilyne C. Waldo, PhD
Email: merilyne.waldo@va.gov
Phone: 303-399-8020 |
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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 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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