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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: Active Phase 3 study of Anxiety Disorders, sponsored by Children's Hospital Los Angeles.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Patient ratings of anxiety symptom severity. Possible range of scores is 0-82, with higher scores indicating greater severity.

Conditions Studied

Interventions

  • BEHAVIORAL Cognitive Behavioral Therapy (CBT)
  • DRUG Fluoxetine

Study Locations (1)

California

  • Children's Hospital Los Angeles - Los Angeles

Trial Details

FieldValue
Enrollment Target 316 participants
Start Date 2021-02-10
Est. Completion 2026-07
Phase Phase 3
Children's Hospital Los Angeles

119 total trials

What the registry record for NCT04760275 still lists

NCT04760275 is an interventional study that assigns participants to a tested intervention. The registered 316 participants enrollment target is mid-sized for trials with a published cap, below the 1,136-participant average among 84 other Anxiety Disorders trials with a reported enrollment target (72% lower).

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 a single indexed study location in 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.

Similar trials for Anxiety Disorders

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04760275's enrollment target sits among peer trials

316 18th of 84 higher than 67 of 84 other Anxiety Disorders trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Anxiety Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04760275, the US trial registry maintained by the National Library of Medicine. NCT04760275 (mid enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.