Fluoxetine vs CBT in Childhood Anxiety Disorders

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 isn't 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 - i.e., 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

NCT Number	NCT04760275
Lead Sponsor	Children's Hospital Los Angeles Collaborators: Patient-Centered Outcomes Research Institute
Conditions	Anxiety Disorders
Enrollment	316 participants
Start Date	2021-02-10
Primary Completion	2025-02-23 (estimated)
Study Completion	2026-07 (estimated)
Updated on ClinicalTrials.gov	2025-04-11