|
|
View Clinical Trial (Medical Research Study)
|
A Study for Assessing Treatment of Patients Ages 10-17 With Bipolar Depression - NCT00844857-33319 (Clinical Trial 272303)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy272303.aspx
|
** Please review additional "Nearby Studies" on right ----->
|
|
 |
 |
|
| City: |
|
Fort Lauderdale |
|
State:
|
|
FL |
| Zip Code: |
|
33319 |
| Conditions: |
|
Bipolar Depression |
| Purpose: |
|
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)
|
| Study summary: |
|
|
| Criteria: |
|
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 |
|
|
|
| Study is available at: |
|
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fort Lauderdale, FL 33319
United States
Primary Contact:
There may be multiple sites in the clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone: 1-317-615-4559 |
|
|
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.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 16, 2010 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|