Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-01-02 @ 12:41 PM
Study NCT ID:
NCT02017535
Status:
COMPLETED
Last Update Posted:
2020-03-23
First Post:
2013-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Adaptive Treatment Strategy for Adolescent Depression-Continuation
Sponsor:
University of Minnesota
Organization:
Study Overview
Official Title:
A Personalized Approach to Achieving a Sustained Response to Treatment for Adolescent Depression
Status:
COMPLETED
Status Verified Date:
2020-03
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:
PTAD GIA
Brief Summary:
Aim 1: Assess the feasibility and acceptability of the personalized continuation treatment strategy.
Aim 2: Estimate variances of primary and secondary outcomes with the continuation treatment.
Aim 3: Conduct exploratory hypothesis-generating analyses to inform further development of the personalized continuation treatment strategy to be tested in a subsequent R01 proposal.
Aim 2: Estimate variances of primary and secondary outcomes with the continuation treatment.
Aim 3: Conduct exploratory hypothesis-generating analyses to inform further development of the personalized continuation treatment strategy to be tested in a subsequent R01 proposal.
Detailed Description:
Male and female adolescents (ages 12-18) will be eligible for the study if they completed acute phase treatment and showed at least a partial response to treatment (CGI-I of minimally improved or better (CGI-I \< 3)). Adolescents will enter continuation treatment having either received 12 sessions of IPT-A, 16 sessions of IPT-A, or 12 sessions of IPT-A plus fluoxetine.This is a continuation of the study "An Adaptive Treatment Strategy for Adolescent Depression (PTAD)" NCT01802437
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?: