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Fluoxetine vs CBT in Childhood Anxiety Disorders

Study acronym: SMART
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Minor Study Identification, Study Statusv8
  2. Minor Primary completion date: Dec 2024 to Feb 23, 2025
    • Study completion date: Dec 2025 to Jul 2026
    v7
  3. Minor Study Identification, Study Statusv6
  4. Minor Trial status: Recruiting to Active, Not Recruitingv5 Show 4 more changesShow less
    • Enrollment target: estimated 404 to confirmed 316
    • Primary completion date: Aug 2024 to Dec 2024
    • Study completion date: Aug 2025 to Dec 2025
    • Site details revised
  5. Minor Primary completion date: Apr 2024 to Aug 2024
    • Study completion date: Apr 2025 to Aug 2025
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Minor Primary completion date: Sep 1, 2024 to Apr 2024
    • Study completion date: Sep 1, 2025 to Apr 2025
    • Site contact updated
    • Eligibility criteria expanded, about 1 word
    v3
  2. Minor Eligibility criteria expanded, about 260 wordsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT04760275
Lead Sponsor Children's Hospital Los Angeles
Collaborators: Patient-Centered Outcomes Research Institute
Conditions
(from sponsor)
Anxiety Disorders
Related terms Anxiety Disorders
Enrollment 316 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov