Combination Therapy for Anxiety Disorders
(PCAY Trial)
Trial Summary
What is the purpose of this trial?
Pediatric onset anxiety disorders (generalized anxiety, social anxiety, separation anxiety) are highly prevalent, and if untreated, are impairing into adolescence and adulthood. In the largest comparative efficacy study remission occurred in about 65% of children and adolescents treated with a combination of a selective serotonin reuptake inhibitors (SSRI) and cognitive behavioral therapy (CBT). In contrast, CBT without an SSRI achieved remission in 35% of children at 3 months and 45% at 6 months-a 30% and 20% difference, respectively. Despite the difference in remission rates, CBT alone is the preferred treatment of most patients and families. Lack of awareness of the significant difference in remission rates and concerns about medication side effects may drive patient and family preference even though SSRIs have a positive safety profile. Critiques of CBT in the above study suggest that CBT was not as effective as it could be due to short treatment duration, restricted family involvement and limited exposure sessions. Would the combination of CBT and an SSRI still be superior to CBT only, if CBT was of longer duration, and included more family involvement and exposure sessions? In the Partners in Care for Anxious Youth (PCAY) study, children and adolescents with an anxiety disorder ages 7-17 years followed in pediatric primary care clinics affiliated with three institution: Lurie Children's Hospital of Chicago, University of California Los Angeles and University of Cincinnati will be randomized to one of two treatment arms; either CBT only or CBT combined with an SSRI (either fluoxetine, sertraline, or escitalopram). CBT in PCAY will be 6 months in duration and include more family involvement, and more exposure opportunities than past trials. The 6-month acute treatment phase will be followed by 6 months of followup. The primary outcome will be anxiety symptom remission and reduction in impairment over 6 and 12-months.
Do I have to stop taking my current medications to join the trial?
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.
Will I have to stop taking my current medications?
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.
What data supports the idea that Combination Therapy for Anxiety Disorders is an effective treatment?
The available research shows that combining Cognitive Behavioral Therapy (CBT) with medication, like SSRIs (a type of drug), can be effective for treating anxiety disorders. One study found that this combination is more effective for panic disorder than using either CBT or the drug alone. Another study suggests that CBT is as effective as drugs for treating various anxiety disorders, and combining them might offer additional benefits, although more research is needed to confirm this.12345
What data supports the effectiveness of the combination therapy for anxiety disorders?
What safety data exists for combination therapy for anxiety disorders?
The safety data for combination therapy involving Cognitive Behavioral Therapy (CBT) and medications like sertraline, citalopram, and escitalopram includes findings from various studies. A pilot study on Cambodian refugees with PTSD showed that combining CBT with sertraline provided additional benefits compared to sertraline alone. Another study highlighted the potential cardiac toxicity of citalopram and escitalopram, suggesting caution in patients with a history of syncope or poisoning, and recommending ECGs for elderly patients. Overall, these treatments have demonstrated efficacy and safety in treating anxiety-related disorders, but specific precautions may be necessary for certain populations.678910
Is combination therapy for anxiety disorders safe?
Combination therapy involving medications like sertraline, citalopram, and escitalopram, often used with cognitive behavioral therapy (CBT), is generally considered safe for humans. However, there are concerns about potential heart-related side effects with citalopram and escitalopram, especially in people with a history of fainting or poisoning, so an electrocardiogram (a heart test) is recommended for older patients.678910
Is the combination of Cognitive Behavioral Therapy (CBT) and drugs like Zoloft, Lexapro, and Prozac a promising treatment for anxiety disorders?
How does the combination treatment for anxiety disorders differ from other treatments?
The combination treatment for anxiety disorders, which includes Cognitive Behavioral Therapy (CBT) and medications like SSRIs (such as Escitalopram, Fluoxetine, and Sertraline), is unique because it aims to maximize benefits by addressing both psychological and biological aspects of anxiety. While CBT focuses on changing thought patterns, SSRIs help balance brain chemicals, and together they may offer more comprehensive relief than either treatment alone, especially for conditions like panic disorder.111121314
Research Team
John Walkup, MD
Principal Investigator
Chair, Pritzker Department of Psychiatry and Behavioral Health
Eligibility Criteria
This trial is for children and teens aged 7-17 with separation anxiety, generalized anxiety, or social anxiety. They must be medically cleared and have a primary caretaker involved. It's not for those with certain severe psychiatric disorders, major medical illnesses that could interfere, or if they're pregnant without using birth control.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either CBT only or CBT combined with an SSRI for 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cognitive Behavioral Therapy (CBT)
- Combination therapy (COMB)
- Escitalopram
- Fluoxetine
- Sertraline
Cognitive Behavioral Therapy (CBT) is already approved in United States, European Union, Canada for the following indications:
- Chronic pain
- Anxiety disorders
- Depressive disorders
- Trauma-related disorders
- Chronic pain
- Anxiety disorders
- Depressive disorders
- Trauma-related disorders
- Chronic pain
- Anxiety disorders
- Depressive disorders
- Trauma-related disorders
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ann & Robert H Lurie Children's Hospital of Chicago
Lead Sponsor
University of Cincinnati
Collaborator
University of California, Los Angeles
Collaborator