Fluoxetine vs CBT in Childhood Anxiety Disorders

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

316

Participants

Timeline

Start Date

February 10, 2021

Primary Completion Date

February 23, 2025

Study Completion Date

July 31, 2026

Conditions
Anxiety Disorders
Interventions
DRUG

Fluoxetine

"This will be a single-blind SMART design of 24 weeks duration that will employ two sequential levels of randomization, one in each of two 12-week stages of the study.~In Stage 1, participants will be randomized 1:1 to receive 12 weeks of the medication fluoxetine in upward-titrated dosages. In Stage 2, also 12 weeks in duration, participants who remit during the first 12 weeks of treatment will continue maintenance-level therapy with fluoxetine. All participants who do not remit will be randomized (1:1) to either (1) optimization of fluoxetine (increasing the dose of fluoxetine as tolerated), or (2) optimization of fluoxetine and addition of Cognitive Behavioral Therapy (CBT)."

BEHAVIORAL

Cognitive Behavioral Therapy (CBT)

"This will be a single-blind SMART design of 24 weeks duration that will employ two sequential levels of randomization, one in each of two 12-week stages of the study.~In Stage 1, participants will be randomized 1:1 to receive 12 weeks of weekly CBT implemented with Coping Cat (CC). In Stage 2, also 12 weeks in duration, participants who remit during the first 12 weeks of treatment will continue maintenance-level therapy with CBT. All participants who do not remit will be randomized (1:1) to either (1) optimization of CBT (intensifying exposure practice and skills review), or (2) optimization of CBT and addition of the medication fluoxetine."

Trial Locations (1)

90027

Children's Hospital Los Angeles, Los Angeles

All Listed Sponsors
collaborator

Patient-Centered Outcomes Research Institute

OTHER

lead

Children's Hospital Los Angeles

OTHER