ARTICLES
Fluoxetine for the Treatment of Childhood Anxiety Disorders: Open-Label, Long-Term Extension to a Controlled Trial

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ABSTRACT

Objective

To assess the efficacy of fluoxetine for the long-term treatment of children and adolescents with anxiety disorders, including generalized anxiety disorder, separation anxiety disorder, and/or social phobia.

Method

Children and adolescents (7-17 years old) with anxiety disorders were studied in open treatment for 1 year after they completed a randomized, controlled trial (RCT) comparing fluoxetine and placebo. The follow-up phase assessments included clinician, parent, and child ratings with measures of global severity, global improvement, and anxiety symptoms.

Results

Subjects taking fluoxetine (n = 42) were compared with those taking no medication (n = 10) during follow-up on anxiety changes from the end of the RCT through the follow-up period. Statistical models included RCT assignment and follow-up psychological treatment. Excluded subjects took other medications (n = 4) or did not complete follow-up (n = 18). Compared with subjects taking no medication, subjects taking fluoxetine showed significantly superior follow-up outcomes on most measures, including clinician, parent, and child ratings.

Conclusions

The results suggest that fluoxetine is clinically effective for the maintenance treatment of anxiety disorders in children and adolescents. A major limitation, however, was the lack of RCT methodology in the follow-up phase. RCTs are needed to determine the long-term risks and benefits of fluoxetine for this group.

Section snippets

Sample and Recruitment

The sample for the RCT has been described in detail by Birmaher et al. (2003). In summary, children 7 to 17 years old with DSM-IV (American Psychiatric Association, 1994) GAD, SAD, and/or SP by Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (K-SADS-PL) with significant functional impairment were recruited through advertisements and an outpatient clinic. Subjects with current major depressive, dysthymic, or disruptive behavior disorders; a

RESULTS

A flow chart depicting the standing of subjects throughout the RCT and follow-up phases is presented in Figure 1. Fifty-six of 74 (76%) subjects completed the 1-year follow-up assessment. There were no significant differences between those with and without follow-up assessments on age (t = 0.6, df = 72, p = .6), sex (χ2 = 0.2, df = 1, p = .7), socioeconomic status (χ2 = 0.6.1, df = 4, p = .2), ethnic group (χ2 = 0.1.7, df = 1, p = .2), presence of comorbid disorders (χ2 = 0.2, df = 1, p = .6),

DISCUSSION

In this study, children and adolescents with anxiety disorders taking fluoxetine were increasingly less symptomatic than those taking no medication during the course of a long-term treatment period. This positive result was generally consistent across clinician, parent, and child ratings. Among those receiving fluoxetine, only 5% were judged by clinicians to be not improved at 1-year follow-up, in contrast to 30% of the group receiving no medication. On parent, child, and clinician anxiety

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    • Cited by (0)

    This work was supported by NIMH grantR01 MH53681 and in part by NIMH grantsMH55123 ;N01-7008 and NIAAAK02 AA00291 . The authors acknowledge Eli Lilly & Company for providing fluoxetine and placebo capsules.

    Disclosure: Dr. Clark is a consultant for Forest Research Institute. Dr. Muthen is the codeveloper of the software program Mplus. The other authors have no financial relationships to disclose.

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    Copyright © 2005 The American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.