Combination Therapy for Anxiety Disorders

(PCAY Trial)

This trial aims to determine if combining cognitive behavioral therapy (CBT) with medication (such as an SSRI like fluoxetine, sertraline, or escitalopram) is more effective than CBT alone for treating anxiety disorders in children and teens. The focus is on common anxiety issues, including separation anxiety, generalized anxiety, and social anxiety. Researchers will compare the effectiveness of these treatments over a 6-month period, followed by another 6 months of follow-up, to assess their impact on reducing anxiety symptoms and improving daily life. Children aged 7-17 with one of these anxiety disorders may be suitable candidates, especially if they have a supportive caregiver involved in their care. As a Phase 3 trial, this study represents the final step before FDA approval, offering a chance to contribute to potentially groundbreaking treatment advancements.

The trial protocol does not specify if you must stop taking your current medications. However, if you have experienced minimal or no change on an adequate dose of certain medications for anxiety, you may be excluded from the trial. It's best to discuss your specific situation with the trial coordinators.

The trial does not specify if you need to stop taking your current medications. However, if you have been on certain medications like fluoxetine, sertraline, citalopram, or escitalopram at specific doses for at least 6 of the last 10 weeks, you may not be eligible to participate.

Research has shown that using Cognitive Behavioral Therapy (CBT) with medications like SSRIs (selective serotonin reuptake inhibitors) is generally safe for treating anxiety disorders. Studies have found that combining CBT with SSRIs such as fluoxetine, sertraline, or escitalopram effectively reduces anxiety symptoms. Most people tolerate these medications well, and they have a good safety record.

The FDA has already approved SSRIs for treating anxiety and depression, indicating their safety for use. Combining CBT with these medications often yields better results than using CBT alone. While CBT is effective on its own, adding medication can enhance its effectiveness without significantly increasing the risk of side effects.

Researchers are excited about the combination therapy (COMB) for anxiety disorders because it uniquely pairs cognitive behavioral therapy (CBT) with one of three well-known medications: fluoxetine, sertraline, or escitalopram. This dual approach could potentially enhance treatment effectiveness by addressing both the psychological and biochemical aspects of anxiety. Unlike standard treatments that typically focus on either therapy or medication alone, this combination may offer a more comprehensive way to manage symptoms, potentially leading to faster and more sustained relief for patients.

Research shows that using both talk therapy, known as cognitive behavioral therapy (CBT), and a type of medication called a selective serotonin reuptake inhibitor (SSRI) is usually more effective for treating anxiety disorders than using CBT alone. In this trial, participants in the combination therapy (COMB) arm will receive CBT along with one of three study medications: fluoxetine, sertraline, or escitalopram. One study found that about 65% of children and teens overcame their anxiety when treated with both CBT and an SSRI. In comparison, only 35% improved with just CBT after 3 months, and 45% after 6 months. Other studies suggest that adding medication to CBT helps reduce anxiety symptoms more than CBT by itself. Overall, combining therapy and medication has proven more effective in easing anxiety symptoms.²⁶⁷⁸⁹