Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00332787
Status:
COMPLETED
Last Update Posted:
2014-01-08
First Post:
2006-06-01
Brief Title:
Determining Optimal Continuation Treatment Duration for Depressed Children and Adolescents
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Childhood Depression Remission and Relapse
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine the optimal length of continuation treatment with fluoxetine for children and adolescents with major depressive disorder as well as the factors that may contribute to positive response during acute and continuation treatment
Detailed Description:
Depression is a serious medical illness that affects all ages and populations However it has only been within the last 10 years that sufficient attention has been devoted to researching treatments for depression in children and adolescents Symptoms of depression in this age group vary but some common signs include pretending to be sick refusing to go to school clinging to a parent or worrying that a parent may die Older children may sulk get into trouble at school act in a negative or grouchy way or feel misunderstood Recent studies on selective serotonin reuptake inhibitors SSRIs one class of antidepressant medications have shown that SSRIs are effective in reducing depression symptoms The optimal duration of treatment however has yet to be established This study will determine the optimal length of continuation treatment with fluoxetine for children and adolescents with major depressive disorder as well as the factors that may contribute to positive response during acute and continuation treatment
Participants in this study will first attend three study visits over a 2-week period to determine eligibility All eligible individuals will be treated with fluoxetine for 12 weeks Dosages will be determined by the study physician and will be based on clinical response to treatment Study visits will occur weekly for the first 4 weeks and biweekly for the remaining 2 months Depression symptoms general changes and adverse reactions will be assessed Participants whose symptoms have improved will be eligible to enter the discontinuation phase of the study which will entail random assignment to either fluoxetine or placebo for an additional 24 weeks Study visits will occur biweekly for 3 months and monthly for the remaining 3 months Depression symptoms and medication side effects will be assessed at these visits
Participants in this study will first attend three study visits over a 2-week period to determine eligibility All eligible individuals will be treated with fluoxetine for 12 weeks Dosages will be determined by the study physician and will be based on clinical response to treatment Study visits will occur weekly for the first 4 weeks and biweekly for the remaining 2 months Depression symptoms general changes and adverse reactions will be assessed Participants whose symptoms have improved will be eligible to enter the discontinuation phase of the study which will entail random assignment to either fluoxetine or placebo for an additional 24 weeks Study visits will occur biweekly for 3 months and monthly for the remaining 3 months Depression symptoms and medication side effects will be assessed at these visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR CT-M | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH039188 |
| R01MH039188 | NIH | None | None |