← Back to Search

Fluoxetine vs Cognitive Behavioural Therapy for Childhood Anxiety Disorders (SMART Trial)

Phase 3

Waitlist Available

Led By Bradley S. Peterson, MD

Research Sponsored by Children's Hospital Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients ages 8-17

Patients with an anxiety disorder (generalized anxiety, separation anxiety, panic, or social anxiety) on the Schedule for Affective Disorders and Schizophrenia for School-Aged Children, computerized version (KSADS-COMP)

Must not have

Patients currently receiving psychotherapy

Due to the cognitive and socio-emotional demands of the CBT protocol, we will exclude youths who are likely to be functioning at a developmental level outside the minimum age for the treatment manual (age 8): Youths who are placed outside of a general education (GE) classroom for > 50% of the school day or require a one-on-one classroom aide to maintain placement in a GE class, or are performing academically below the 2nd grade level in reading and language arts

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will help determine what the best course of action is for treating anxiety disorders in children.

Who is the study for?

This trial is for children aged 8-17 with moderate to severe anxiety disorders, as measured by specific scales (SCARED-5, SCARED-41, CAIS). They must be fluent in English or Spanish and agree to random treatment assignment. Excluded are those on certain medications like MAOIs or antipsychotics recently, pregnant females not using birth control, anyone with PTSD or unstable medical conditions, and those below a second-grade level in reading/language arts.

What is being tested?

The study compares starting treatment with Cognitive Behavioral Therapy (CBT) versus fluoxetine medication for childhood anxiety disorders. If there's no remission by week 12, the study will test if optimizing the initial treatment or adding the other modality improves symptoms more by week 24. It also examines which sequence of treatments is most effective over a year.

What are the potential side effects?

Fluoxetine may cause stomach upset, sleep problems, headaches, and behavioral changes such as increased agitation or mood swings. CBT generally has fewer side effects but can sometimes lead to temporary increases in anxiety levels due to exposure techniques used during therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 8 and 17 years old.

Select...

I have been diagnosed with an anxiety disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently undergoing psychotherapy.

Select...

My child is in a regular class most of the day and reads at or above 2nd grade level.

Select...

I am not pregnant and use effective birth control.

Select...

I am currently taking fluoxetine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Youth - SCARED (Screen for Child Anxiety Related Disorders)

Secondary study objectives

Parent - Child Anxiety Impact Scale (CAIS)

Parent - SCARED (Screen for Child Anxiety Related Disorders)

Youth - Child Anxiety Impact Scale (CAIS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Group I: Medication - FluoxetineActive Control1 Intervention

Approved medication by the U.S. Food and Drug Administration (FDA) for treating anxiety disorders in children. The study's starting dose, and minimum permitted, will be 10 mg/day; should that not be tolerated, the patient will be withdrawn from active treatment (but not from study follow-up). After 1 week at 10 mg/day, the dose will increase to 20 mg/day. After completion of week 4, 10 mg/day dose increases will be permitted every other week as tolerated, up to a maximum daily dose of 80 mg/day. If patients are on doses \>20mg/day, the total daily dose can be prescribed either once daily or split into twice daily administrations.

Group II: Cognitive Behavioral Therapy (CBT)Active Control1 Intervention

Type of talk therapy that aims to identify and replace negative thoughts, using positive behavioral skills to create and maintain positive moods and healthy relationships. The Coping Cat (CC) program will be used as the behavioral intervention for this study.CC is an established evidence-based CBT treatment for pediatric anxiety. It is delivered in individual therapy sessions with anxious children.

0 / 6Eligibility criteria met