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.
Phase:
Phase 3
Details
Lead Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators:
University of California, Los Angeles University of Cincinnati