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Child/Adolescent Anxiety Multimodal Study: Evaluating Safety

Identifieur interne : 003955 ( Main/Exploration ); précédent : 003954; suivant : 003956

Child/Adolescent Anxiety Multimodal Study: Evaluating Safety

Auteurs : Moira A. Rynn ; John T. Walkup ; Scott N. Compton ; Dara J. Sakolsky ; Joel T. Sherrill ; Sa Shen ; Philip C. Kendall ; James Mccracken ; Anne Marie Albano ; John Piacentini ; Mark A. Riddle ; Courtney Keeton ; Bruce Waslick ; Allan Chrisman ; Satish Iyengar ; John S. March ; Boris Birmaher

Source :

RBID : PMC:4362776

Descripteurs français

English descriptors

Abstract

Objective

To evaluate the frequency of adverse events (AEs) across four treatment conditions in the Child/Adolescent Anxiety Multimodal Study (CAMS), and to compare the frequency of AEs between children and adolescents.

Method

Participants ages 7-17 years (M=10.7) meeting the DSM-IV criteria for one or more of the following disorders: separation anxiety disorder, generalized anxiety disorder, or social phobia were randomized (2:2:2:1) to cognitive-behavioral therapy (CBT, n=139), sertraline (SRT, n=133), combination of both (COMB, n=140), or pill placebo (PBO, n=76). AEs were collected via a standardized inquiry method plus a self-report Physical Symptom Checklist (PSC).

Results

There were no differences between the double-blinded conditions (SRT vs. PBO) for total physical and psychiatric AEs or any individual physical or psychiatric AEs. The rates of total physical AEs were greater in the SRT-alone treatment condition when compared to CBT (p<.01) and COMB (p<.01). Moreover, those who received SRT alone reported higher rates of several physical AEs when compared to COMB and CBT. The rate of total psychiatric AEs was higher in children (≤12 years) across all arms (31.7% vs. 23.1%, p<.05). Total PSC scores decreased over time with no significant differences between treatment groups.

Conclusion

The results support the tolerability/safety of selective serotonin reuptake inhibitor (SSRI) treatment for anxiety disorders even after adjusting for the number of reporting opportunities leading to no differences in overall rates of AEs. Few differences occurred on specific items. Additional monitoring of psychiatric AEs is recommended in children (≤12 years).


Url:
DOI: 10.1016/j.jaac.2014.12.015
PubMed: 25721183
PubMed Central: 4362776


Affiliations:


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<term>Enfant</term>
<term>Femelle</term>
<term>Humains</term>
<term>Indice de gravité médicale</term>
<term>Inhibiteurs de la capture de la sérotonine (effets indésirables)</term>
<term>Inhibiteurs de la capture de la sérotonine (usage thérapeutique)</term>
<term>Modèles logistiques</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
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<term>Sertraline (usage thérapeutique)</term>
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<term>Serotonin Uptake Inhibitors</term>
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<term>Inhibiteurs de la capture de la sérotonine</term>
<term>Sertraline</term>
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<term>Phobic Disorders</term>
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<term>Inhibiteurs de la capture de la sérotonine</term>
<term>Sertraline</term>
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<term>Adolescent</term>
<term>Child</term>
<term>Cognitive Therapy</term>
<term>Combined Modality Therapy</term>
<term>Diagnostic and Statistical Manual of Mental Disorders</term>
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<term>Humans</term>
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<sec id="S1">
<title>Objective</title>
<p id="P1">To evaluate the frequency of adverse events (AEs) across four treatment conditions in the Child/Adolescent Anxiety Multimodal Study (CAMS), and to compare the frequency of AEs between children and adolescents.</p>
</sec>
<sec id="S2">
<title>Method</title>
<p id="P2">Participants ages 7-17 years (M=10.7) meeting the
<italic>DSM-IV</italic>
criteria for one or more of the following disorders: separation anxiety disorder, generalized anxiety disorder, or social phobia were randomized (2:2:2:1) to cognitive-behavioral therapy (CBT, n=139), sertraline (SRT, n=133), combination of both (COMB, n=140), or pill placebo (PBO, n=76). AEs were collected via a standardized inquiry method plus a self-report Physical Symptom Checklist (PSC).</p>
</sec>
<sec id="S3">
<title>Results</title>
<p id="P3">There were no differences between the double-blinded conditions (SRT vs. PBO) for total physical and psychiatric AEs or any individual physical or psychiatric AEs. The rates of total physical AEs were greater in the SRT-alone treatment condition when compared to CBT (p<.01) and COMB (p<.01). Moreover, those who received SRT alone reported higher rates of several physical AEs when compared to COMB and CBT. The rate of total psychiatric AEs was higher in children (≤12 years) across all arms (31.7% vs. 23.1%, p<.05). Total PSC scores decreased over time with no significant differences between treatment groups.</p>
</sec>
<sec id="S4">
<title>Conclusion</title>
<p id="P4">The results support the tolerability/safety of selective serotonin reuptake inhibitor (SSRI) treatment for anxiety disorders even after adjusting for the number of reporting opportunities leading to no differences in overall rates of AEs. Few differences occurred on specific items. Additional monitoring of psychiatric AEs is recommended in children (≤12 years).</p>
</sec>
</div>
</front>
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