Fluoxetine for the treatment of childhood anxiety disorders: open-label, long-term extension to a controlled trial.
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.


METHODS
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.
Clark
Duncan B
DB
Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, PA 15213, USA. clarkdb@upmc.edu
Birmaher
Boris
B
Axelson
David
D
Monk
Kelly
K
Kalas
Catherine
C
Ehmann
Mary
M
Bridge
Jeffrey
J
Wood
D Scott
DS
Muthen
Bengt
B
Brent
David
D
D000293:Adolescent; D001008:Anxiety Disorders / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D001010:Anxiety, Separation / Q000175:diagnosis / Q000188:drug therapy / Q000523:psychology; D002648:Child; D005260:Female; D005473:Fluoxetine / Q000009:adverse effects / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D008134:Long-Term Care; D008297:Male; D010552:Personality Assessment; D010698:Phobic Disorders / Q000175:diagnosis / Q000188:drug therapy / Q000523:psychology; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D005473:Fluoxetine; D017367:Selective Serotonin Reuptake Inhibitors