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NCT04760275 · ClinicalTrials.gov registry record · Phase 3
Fluoxetine vs CBT in Childhood Anxiety Disorders
A Phase 3 study of Anxiety Disorders, sponsored by Children's Hospital Los Angeles.
- Active
- Registry status
- Phase 3
- Development phase
- 316
- Enrollment target
- 1
- Study location
NCT04760275 is a Phase 3 study of Anxiety Disorders that is active but no longer recruiting, run by Children's Hospital Los Angeles. The registered enrollment target is 316 participants, below the 1,136-participant average among 84 other Anxiety Disorders trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04760275, a Phase 3 study of Anxiety Disorders, is active but no longer recruiting, sponsored by Children's Hospital Los Angeles.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 316 participants
- Enrollment target
- 1
- Study location
Study 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 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
Conditions Studied
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy (CBT)
- DRUG Fluoxetine
Study Locations (1)
California
- Children's Hospital Los Angeles - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 316 participants |
| Start Date | 2021-02-10 |
| Est. Completion | 2026-07 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04760275
The ClinicalTrials.gov registry entry for NCT04760275 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 316 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,136-participant average among 84 other Anxiety Disorders trials with a reported enrollment target (72% lower). The listed sponsor is Children's Hospital Los Angeles, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Anxiety Disorders appearing as the primary indexed condition, and to 2 interventions - of which Cognitive Behavioral Therapy (CBT) is the first listed.
NCT04760275 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04760275 about?
NCT04760275 is a clinical study titled "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 ...
What is the current status of trial NCT04760275?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 316 participants. The study started on 2021-02-10. Estimated completion is 2026-07.
What conditions does trial NCT04760275 study?
This clinical trial studies the following conditions: Anxiety Disorders.
What interventions are being tested in trial NCT04760275?
The interventions under investigation include: Cognitive Behavioral Therapy (CBT) (BEHAVIORAL), Fluoxetine (DRUG).
Who is sponsoring clinical trial NCT04760275?
This trial is sponsored by Children's Hospital Los Angeles, which has 119 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04760275 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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