Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04760275
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2021-02-09
Brief Title:
Fluoxetine Vs CBT in Childhood Anxiety Disorders
Sponsor:
Childrens Hospital Los Angeles
Organization:
Childrens Hospital Los Angeles
Study Overview
Official Title:
A Sequential Multiple Assignment Randomized Trial SMART Assessing Medication and CBT Sequencing Strategies in the Treatment of Predominantly Ethnic Minority Underserved Youth with Anxiety Disorders
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
SMART
Brief Summary:
Treatment of every child with anxiety disorder begins with the question of which treatment to start first Both fluoxetine and CBT have strong empirical support but few studies have compared their initial effectiveness head-to-head and none has investigated what to do if the treatment tried first isnt working well-whether to optimize the treatment already begun or to add the other treatment
Aims of the study
1 The study will assess whether beginning with Cognitive Behavioral Therapy CBT or fluoxetine medication is more effective in improving youth-rated anxiety symptoms over the 24-week intervention
2 If the initial intervention fails to induce clinical remission by week 12 the study will assess whether optimizing the initial treatment modality alone or adding the other modality to the first yields better symptom improvement by week 24
3 The study will assess whether one sequence of treatment modalities - ie CBT followed by optimized CBT CBT followed by optimized CBT medication medication followed by optimized medication medication followed by optimized medication CBT -- is significantly better or worse than predicted from the two main effects
4 The study will assess the stability of treatment response for 12 months following completion of the 24-week trial
Aims of the study
1 The study will assess whether beginning with Cognitive Behavioral Therapy CBT or fluoxetine medication is more effective in improving youth-rated anxiety symptoms over the 24-week intervention
2 If the initial intervention fails to induce clinical remission by week 12 the study will assess whether optimizing the initial treatment modality alone or adding the other modality to the first yields better symptom improvement by week 24
3 The study will assess whether one sequence of treatment modalities - ie CBT followed by optimized CBT CBT followed by optimized CBT medication medication followed by optimized medication medication followed by optimized medication CBT -- is significantly better or worse than predicted from the two main effects
4 The study will assess the stability of treatment response for 12 months following completion of the 24-week trial
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None