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Fluoxetine vs Cognitive Behavioural Therapy for Childhood Anxiety Disorders (SMART Trial)
SMART Trial Summary
This trial will help determine what the best course of action is for treating anxiety disorders in children.
SMART Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSMART Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SMART Trial Design
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Who is running the clinical trial?
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- I am currently undergoing psychotherapy.I am willing to pause or stop my current psychotherapy to join the 24-week study.I haven't taken certain mental health or seizure medications in the last 2 weeks.I am willing to stop my current anxiety or sleep medication to join the study.You have experienced at least one traumatic event and have shown significant emotional reactions to it, as reported by your parents.I am between 8 and 17 years old.My child is in a regular class most of the day and reads at or above 2nd grade level.I am not pregnant and use effective birth control.I scored a 4 on a mental health assessment and cannot access specialty mental health treatment.I have been diagnosed with an anxiety disorder.You have been diagnosed with obsessive-compulsive disorder (OCD) and this study's treatments would not be suitable for you.I score a 4 because my symptoms are frequent, long-lasting, or hard to manage.You have been diagnosed with post-traumatic stress disorder (PTSD) and the treatments used in this study may not be suitable for your condition.You have high scores on two questionnaires that measure anxiety symptoms, indicating that you may have severe anxiety.You have a high score on a test that measures how much anxiety is affecting your daily life.I am currently taking fluoxetine.Both I and my caregiver speak English or Spanish fluently.I am in a severe crisis and lack access to necessary support.My parent and I agree to be randomly assigned to either a medication or therapy treatment.
- Group 1: Medication - Fluoxetine
- Group 2: Cognitive Behavioral Therapy (CBT)
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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