316 Participants Needed

Fluoxetine vs Cognitive Behavioural Therapy for Childhood Anxiety Disorders

(SMART Trial)

CA
TT
CM
BS
Overseen ByBradley S. Peterson, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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 intervention2. 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 243. 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 effects4. The study will assess the stability of treatment response for ≥12 months following completion of the 24-week trial

Do I need to stop my current medications to join the trial?

If you are currently taking fluoxetine, you cannot participate in the trial. If you are on other medications like SSRIs, SNRIs, antidepressants, or benzodiazepines, you may need to taper off these medications to join the study, but this will be done with guidance from your current doctor.

Is fluoxetine safe for children with anxiety disorders?

Fluoxetine, a type of antidepressant, is generally considered safe for children with anxiety disorders, but it requires careful assessment and monitoring due to potential risks like increased suicidal behavior. It is the only SSRI recommended by some health agencies for children, while others advise against using SSRIs in this age group.12345

How does fluoxetine differ from other drugs for childhood anxiety disorders?

Fluoxetine is unique because it is a selective serotonin reuptake inhibitor (SSRI) that helps increase serotonin levels in the brain, which can improve mood and reduce anxiety. It is often used in combination with cognitive behavioral therapy (CBT) to enhance treatment effectiveness for childhood anxiety disorders.678910

What data supports the effectiveness of the drug fluoxetine for childhood anxiety disorders?

Research shows that fluoxetine can be effective for treating childhood anxiety disorders like separation anxiety and social phobia, with many children showing improvement within 5 weeks of treatment.79101112

Who Is on the Research Team?

BS

Bradley S. Peterson, MD

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am between 8 and 17 years old.
I have been diagnosed with an anxiety disorder.
You have high scores on two questionnaires that measure anxiety symptoms, indicating that you may have severe anxiety.
See 2 more

Exclusion Criteria

Patients scoring a 5
Patients with a current/active psychotic diagnosis (schizophrenia, schizoaffective, schizophreniform, psychosis not otherwise specified (NOS), or depression with psychotic features), as determined by medical chart and medical history review by the site director and PI.
I am currently undergoing psychotherapy.
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Cognitive Behavioral Therapy (CBT) or fluoxetine medication over a 24-week intervention period

24 weeks

Optimization

If initial treatment fails by week 12, treatment is optimized or combined with the other modality for better symptom improvement

12 weeks

Follow-up

Participants are monitored for stability of treatment response for at least 12 months following the 24-week trial

≥12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Cognitive Behavioral Therapy (CBT)
  • Fluoxetine
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Medication - FluoxetineActive Control1 Intervention
Group II: Cognitive Behavioral Therapy (CBT)Active Control1 Intervention

Cognitive Behavioral Therapy (CBT) is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Cognitive Behavioral Therapy for:
🇪🇺
Approved in European Union as Cognitive Behavioural Therapy for:
🇨🇦
Approved in Canada as Cognitive Behavioral Therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials
257
Recruited
5,075,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+

Published Research Related to This Trial

A systematic review of 21 studies found that fluoxetine use during the first trimester of pregnancy does not significantly increase the risk of major fetal malformations, with an odds ratio of 1.12, indicating safety for the fetus.
However, there is a noted increased risk of cardiac malformations associated with fluoxetine use, with an odds ratio of 1.6 from cohort studies, suggesting that this risk may be influenced by factors such as ascertainment bias in reporting.
The fetal safety of fluoxetine: a systematic review and meta-analysis.Riggin, L., Frankel, Z., Moretti, M., et al.[2022]

Citations

Treatment response in depressed adolescents with and without co-morbid attention-deficit/hyperactivity disorder in the Treatment for Adolescents with Depression Study. [2022]
Fluoxetine for the treatment of childhood anxiety disorders: open-label, long-term extension to a controlled trial. [2022]
Fluoxetine for the treatment of childhood anxiety disorders. [2022]
Sequenced treatment alternatives to relieve adolescent depression (STAR-AD): a multicentre open-label randomized controlled trial protocol. [2023]
Open fluoxetine treatment of mixed anxiety disorders in children and adolescents. [2013]
Selective serotonin reuptake inhibitors in pediatric depression: is the balance between benefits and risks favorable? [2022]
Trends in depression and antidepressant prescribing in children and adolescents: a cohort study in The Health Improvement Network (THIN). [2022]
Paroxetine treatment of mood and anxiety disorders in children and adolescents. [2013]
The fetal safety of fluoxetine: a systematic review and meta-analysis. [2022]
Selective serotonin reuptake inhibitors in the treatment of paediatric anxiety disorders: a review. [2022]
[Paroxysmal events after anxiety treatment with fluoxetine in a child with autism spectrum disorder]. [2014]
Fluoxetine in acute treatment of children and adolescents with obsessive-compulsive disorder: a systematic review and meta-analysis. [2020]
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