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Child/Adolescent anxiety multimodal study: evaluating safety.
Moira A Rynn1, John T Walkup2, Scott N Compton3
1Columbia University Medical Center (CUMC)/New York State Psychiatric Institute, New York.
Journal of the American Academy of Child and Adolescent Psychiatry
|February 28, 2015
Summary
Adverse events (AEs) were evaluated in children and adolescents with anxiety disorders. While selective serotonin reuptake inhibitor (SSRI) treatment showed good tolerability, psychiatric AEs were more common in younger children.
Area of Science:
- Child and Adolescent Psychiatry
- Clinical Psychology
- Pharmacology
Background:
- Anxiety disorders are prevalent in children and adolescents.
- Multimodal treatment approaches are increasingly utilized.
- Understanding adverse event profiles is crucial for treatment selection.
Purpose of the Study:
- To assess adverse event (AE) frequency across four treatment arms in the Child/Adolescent Anxiety Multimodal Study (CAMS).
- To compare AE frequency between pediatric and adolescent patient groups.
- To evaluate the safety and tolerability of cognitive-behavioral therapy (CBT), sertraline (SRT), combination therapy (COMB), and placebo (PBO).
Main Methods:
- Randomized controlled trial (RCT) with a 2:2:2:1 allocation ratio.
- Participants (ages 7-17) diagnosed with separation anxiety disorder, generalized anxiety disorder, or social phobia.
- AE data collected via standardized inquiry and Physical Symptom Checklist (PSC).
Main Results:
- No significant differences in overall physical or psychiatric AEs between double-blinded sertraline (SRT) and placebo (PBO).
- Higher rates of physical AEs in the SRT-alone group compared to cognitive-behavioral therapy (CBT) and combination (COMB) therapy.
- Increased psychiatric AEs observed in younger children (≤12 years) across all treatment arms.
Conclusions:
- Selective serotonin reuptake inhibitor (SSRI) treatment is generally well-tolerated for pediatric anxiety disorders.
- Few specific AE differences were noted between treatment conditions.
- Enhanced monitoring for psychiatric AEs is recommended for children aged 12 years and younger.
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