Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00029640
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2002-01-16
Brief Title:
The Treatment of Children and Adolescents With Treatment-Resistant Depression
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Clinical and Neurochemical Effects of Pharmacologic Treatment in Pediatric Depression
Status:
COMPLETED
Status Verified Date:
2004-03
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 seeks to learn about brain function in adolescents with depression and to determine whether adding lithium carbonate to antidepressant medication can reduce depression in children and adolescents Functional magnetic resonance imaging fMRI and magnetic resonance spectroscopy MRS will examine brain chemistry and function
Detailed Description:
The participants may or may not have taken a selective serotonin reuptake inhibitor SSRI such as paroxetine Paxil sertraline Zoloft or fluoxetine Prozac to treat their depression
The participants and their parents are interviewed both individually and together with questions about the childs general mood degree of nervousness and behavior and how family members are doing Children and adolescents will have a physical examination blood tests and intelligence and memory evaluations Tests include standardized questions and tasks that involve looking at pictures remembering things testing reaction times and making simple choices Participants spend time in a mock MRI scanner to become comfortable with the procedure Participants and their parents meet weekly for 2 weeks with a psychologist or psychiatrist for sessions Those who remain depressed after these two sessions will begin study medication
Those who are not currently taking an SSRI will be offered paroxetine Those already taking an SSRI will be randomly assigned to receive either lithium or a placebo non-active pill in addition to the SSRI Treatment continues for 8 weeks During this time the participant and parent meet with the doctor once a week and complete written and oral evaluations Blood will be drawn before medication begins and at the end of the 8-week treatment Participants will have additional blood taken after 1 week on medication to help in deciding whether dose adjustment is needed Additional blood tests might be needed later on to ensure that the dose is correct Those who improve after 8 weeks will continue treatment at NIH until responsibility for their care can be assume by an outside physician Program staff will help in facilitating referrals to physicians who will monitor the medication after the child leaves the study
The participants and their parents are interviewed both individually and together with questions about the childs general mood degree of nervousness and behavior and how family members are doing Children and adolescents will have a physical examination blood tests and intelligence and memory evaluations Tests include standardized questions and tasks that involve looking at pictures remembering things testing reaction times and making simple choices Participants spend time in a mock MRI scanner to become comfortable with the procedure Participants and their parents meet weekly for 2 weeks with a psychologist or psychiatrist for sessions Those who remain depressed after these two sessions will begin study medication
Those who are not currently taking an SSRI will be offered paroxetine Those already taking an SSRI will be randomly assigned to receive either lithium or a placebo non-active pill in addition to the SSRI Treatment continues for 8 weeks During this time the participant and parent meet with the doctor once a week and complete written and oral evaluations Blood will be drawn before medication begins and at the end of the 8-week treatment Participants will have additional blood taken after 1 week on medication to help in deciding whether dose adjustment is needed Additional blood tests might be needed later on to ensure that the dose is correct Those who improve after 8 weeks will continue treatment at NIH until responsibility for their care can be assume by an outside physician Program staff will help in facilitating referrals to physicians who will monitor the medication after the child leaves the study
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 |
|---|---|---|---|
| 02-M-0108 | None | None | None |