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View Clinical Trial (Medical Research Study)
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A Study for Assessing Treatment of Patients Ages 10-17 With Bipolar Depression - NCT00844857-32611 (Clinical Trial 272304)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy272304.aspx
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| City: |
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Gainesville |
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State:
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FL |
| Zip Code: |
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32611 |
| Conditions: |
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Bipolar Depression |
| Purpose: |
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The main goal of this study is to help answer the following research question(s) and not to
treat the child's illness.
- Can this study drug make children with bipolar depression feel better?
- Does this study drug work better than a placebo (sugar pill)?
- Does this study drug cause side effects in children who take it?
- Is this drug safe to use in children? (The study drug is a mixture of olanzapine and
fluoxetine)
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Male or female inpatients or outpatients, 10-17 yrs of age, who have not reached
their 18th birthday prior to screening. Patient must weigh at least 20kg at
screening.
- Must meet diagnostic criteria for current major depressive episode of Bipolar I
Disorder according to the Diagnostic and Statistical Manual of Mental Disorders,
DSM-IV-TR, and confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia
for School Aged Children-Present and Lifetime (K-SADS-PL)
- Patients entering the study will also be scored by the CDRS R (entry score of greater
than or equal to 40) as well as the adolescent-structured YMRS (entry score of less
than or equal to 15 with YMRS Item 1 [elevated mood] score less than equal to 2).
Exclusion Criteria:
- Patients will be excluded if they are, in the opinion of the investigator, actively
suicidal
- Have an acute, serious or unstable medical condition
- Have clinically significant laboratory abnormalities
- Have had one or more seizures of unclear etiology
- Have a current or lifetime diagnosis of any of the following according to DSM-IV
criteria: Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder,
Delusional Disorder, Psychotic Disorder Not Otherwise Specified, Delirium of any
type, Amnestic Disorder, any Substance-Induced Disorder, or any Psychotic Disorder
due to a General Medical Condition, unless there is substantive reason to believe
patient was misdiagnosed |
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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 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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