Ignite Creation Date:
2025-12-25 @ 3:41 AM
Ignite Modification Date:
2025-12-26 @ 2:27 AM
Study NCT ID:
NCT00018902
Status:
COMPLETED
Last Update Posted:
2014-03-12
First Post:
2001-07-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of SSRI-Resistant Depression In Adolescents (TORDIA)
Sponsor:
University of Pittsburgh
Organization:
Study Overview
Official Title:
Treatment of SSRI-Resistant Depression in Adolescents (TORDIA)
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TORDIA
Brief Summary:
The purpose of the study is to determine how best to treat adolescents with depression that is "resistant" to the first SSRI antidepressant they have tried. Participants receive one of three other antidepressant medications, either alone or in combination with cognitive behavioral therapy.
Detailed Description:
The TORDIA study aims to develop useful clinical guidelines for the care and management of adolescent depression. Adolescents ages 12 to 18, currently taking a prescribed selective serotonin reuptake inhibitor (SSRI) and still experiencing depression, participate in a 12-week randomized treatment study that includes one of four conditions: (1) switching to an alternative SSRI, (2) switching to a different non-SSRI antidepressant, (3) switching to an alternative SSRI and receiving cognitive behavioral therapy (CBT), or (4) switching to a different non-SSRI antidepressant and receiving CBT. This is a double-blind study, which means that neither the participant nor the clinical staff will know which of the three possible medications has been assigned. Participants who respond to the assigned treatment will receive 12 additional weeks of the same treatment. Those who do not appear to be getting better will be offered 12 weeks of an alternative, individualized treatment plan based on each participant's particular needs. All participants will receive follow-up psychiatric evaluations for 12 months after the 12-week continuation phase of the study, regardless of treatment adherence.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U01MH061835 | NIH | None | https://reporter.nih.gov/quic… | View |
| TORDIA | None | None | View | |
| DSIR B4-ARD | None | None | View | |
| MH61835 | None | None | View |