Can more intensive therapy replace anxiety meds for kids?
NCT ID NCT04598230
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study tests whether a longer, family-involved form of cognitive behavioral therapy (CBT) can work as well as CBT combined with an antidepressant (SSRI) for children and teens with anxiety disorders. Participants aged 7 to 17 with separation, generalized, or social anxiety will receive either CBT alone for 6 months or CBT plus one of three SSRIs. The goal is to see if the enhanced CBT alone can match the combination's success in reducing anxiety and improving daily functioning.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cognitive Behavioral Therapy (CBT) and selective serotonin reuptake inhibitors (SSRIs: fluoxetine, sertraline, or escitalopram)
- What this could lead to
- If successful, this could show that a longer, more family-involved CBT alone is as effective as CBT plus medication, offering a drug-free option for anxious youth.
- What could go wrong
- This is a Phase 3 trial, but past studies found CBT alone less effective than combination therapy. The enhanced CBT may still fall short, and side effects from SSRIs remain a concern.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 468 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2021
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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7 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria 1. Ages 7-17 years (inclusive at time of consent/assent) 2. Primary Diagnostic and Statistical Manual, 5th Edition (DSM-5) diagnosis of separation anxiety disorder (SAD), and/or generalized anxiety disorder (GAD), and/or social anxiety disorder (SocAD) as determined by self-reported structured interview (MINI-KID) and confirmation by a study clinician. 3. Stable/treated Attention Deficit Hyperactivity Disorder (ADHD), combined or hyperactive impulsive subtypes 4. An available primary caretaker with ongoing patient contact who is legally able to provide consent 5. Medically cleared by a pediatric clinician including a negative urine pregnancy test for females of child-bearing age. Furthermore, female patients must agree to abstain from sexual activity or to use a reliable method of birth control as determined by pediatric clinician during the study. Exclusion Criteria: 1. Patients with the following lifetime psychiatric disorders: moderate to severe autism, bipolar disorder, schizophrenia, or schizoaffective disorder, history of intellectual disability 2. Primary Attention Deficit Hyperactivity Disorder (ADHD), combined or hyperactive impulsive subtypes 3. Major depressive disorder with greater severity than anxiety disorder requiring treatment not provided in PCAY 4. Obsessive Compulsive Disorder (OCD) only (no co-occurring SAD, SocAD or GAD) 5. Patients with a major medical illness that would interfere with participation in the study (e.g., complex, and evolving medical treatments, or require frequent hospitalizations). 6. Patients who are pregnant as indicated by a positive pregnancy test or are sexually active and not using effective birth control. 7. Patients who pose a significant and imminent risk to self or to others. 8. Patients who experienced minimal or no change an adequate dose of evidenced-based medication treatment or CBT for their anxiety disorder. (See medication and CBT exclusions below) 9. Patients or caregiver(s) who do not speak English or Spanish. All materials and treatments will be available in Spanish and English. 10. Children and adolescents with complex psychiatric needs that cannot be managed in primary care and community settings as determined by study local Principal Investigator (PI) and provider teams. Medication Exclusions Fluoxetine * 20 mg for at least 6 of 10 weeks in children \<12 year * 40 mg for at least 6 of 10 weeks in adolescents \>12 years Sertraline * 100 for at least 6 of 10 weeks in children \<12 years * 150 for at least 6 of 10 weeks in adolescents \>12 years Citalopram * 20 mg for at least 6 of 10 weeks in children \>12 years * 30 mg for at least 6 of 10 weeks adolescent \> 12 years Escitalopram * 10 mg for at least 6 of 10 weeks in children \<12 years * 20 mg for at least 6 of 10 weeks in adolescent \>12 years Fluvoxamine * 150 mg for at least 6 of 10 weeks in children \<12 years * 200 mg for at least 6 of 10 weeks in children \< 12 year CBT Exclusions Failed a previous trial of verified CBT for anxiety disorders within the previous year judged adequate by ≥12 exposure-based CBT sessions
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Lurie Children's Hospital and Affiliated Pediatric Practices
Chicago, Illinois, 60611, United States
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UCLA Semel Institute for Neuroscience and Human Behavior
Los Angeles, California, 45219, United States
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University of Cincinnati
Cincinnati, Ohio, 45219, United States
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