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

Phase 3
Recruiting
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24
Awards & highlights

SMART 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.Check my eligibility
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.See study design
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.

SMART Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 8 and 17 years old.
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I have been diagnosed with an anxiety disorder.
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Both I and my caregiver speak English or Spanish fluently.
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My parent and I agree to be randomly assigned to either a medication or therapy treatment.

SMART Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Youth - SCARED (Screen for Child Anxiety Related Disorders)
Secondary outcome measures
Parent - Child Anxiety Impact Scale (CAIS)
Parent - SCARED (Screen for Child Anxiety Related Disorders)
Youth - Child Anxiety Impact Scale (CAIS)

SMART 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.

Find a Location

Who is running the clinical trial?

Children's Hospital Los AngelesLead Sponsor
230 Previous Clinical Trials
5,076,038 Total Patients Enrolled
2 Trials studying Anxiety Disorders
1,150 Patients Enrolled for Anxiety Disorders
Patient-Centered Outcomes Research InstituteOTHER
548 Previous Clinical Trials
29,995,984 Total Patients Enrolled
5 Trials studying Anxiety Disorders
1,568 Patients Enrolled for Anxiety Disorders
Bradley S. Peterson, MDPrincipal InvestigatorChildren's Hospital Los Angeles

Media Library

Cognitive Behavioral Therapy (CBT) Clinical Trial Eligibility Overview. Trial Name: NCT04760275 — Phase 3
Anxiety Disorders Research Study Groups: Medication - Fluoxetine, Cognitive Behavioral Therapy (CBT)
Anxiety Disorders Clinical Trial 2023: Cognitive Behavioral Therapy (CBT) Highlights & Side Effects. Trial Name: NCT04760275 — Phase 3
Cognitive Behavioral Therapy (CBT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04760275 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What purpose does Fluoxetine serve for patients?

"Fluoxetine, a medication, is effective in treating myoclonus and can also help patients with unipolar depression, obsessive-compulsive disorder, anorexia nervosa."

Answered by AI

Are there any other examples where Fluoxetine has been studied?

"Presently, there are 19 active clinical trials testing Fluoxetine with 3 of them being Phase 3 studies. The majority of these research projects are based in New Haven, though there are 27 total locations conducting this kind of research."

Answered by AI

Could you please give a rough estimate of how many people are participating in this test?

"That is correct, the trial is still open and recruiting patients. According to information on clinicaltrials.gov, the study was first posted on February 10th, 2021 and last updated February 9th, 2022. They are looking for 404 participants at 1 location."

Answered by AI

Has the FDA cleared Fluoxetine for therapeutic use?

"Medication - Fluoxetine has received a safety rating of 3 by our team at Power. This is because Phase 3 clinical trials have been conducted, providing some data to support efficacy as well as multiple rounds of data supporting safety."

Answered by AI

Does this research project allow for minors to participate?

"Candidates that meet the age requirement of 8 to 17 years old are welcome to enroll in this study."

Answered by AI

Could I potentially be a part of this research project?

"This trial is seeking 404 participants, all of whom must be between 8 and 17 years old and have a diagnosed anxiety disorder. Other requirements for potential patients include the following: being screened positive for anxiety (SCARED-5 score ≥ 3 and SCARED-41 score ≥ 25), having a CAIS score > 8 , being fluent in either English or Spanish, and having parental consent."

Answered by AI
~39 spots leftby Aug 2024