Fluoxetine was superior to placebo in the acute phase treatment of major depressive disorder in child and adolescent outpatients with severe, persistent depression. Complete remission of symptoms was rare.

Objective-The authors compared fluoxetine and placebo in continuation treatment to prevent relapse of major depressive disorder in children and adolescents.Method-After a detailed evaluation, children and adolescents 7-18 years of age with major depressive disorder were treated openly with fluoxetine. Those who had an adequate response after 12 weeks, as indicated by a Clinical Global Impression improvement score of 1 or 2 and a decrease of at least 50% in Children's Depression Rating Scale-Revised score, were randomly assigned to receive fluoxetine or placebo for an additional 6 months. The primary outcome measures were relapse and time to relapse. Relapse was defined as either a score of 40 or higher on the Children's Depression Rating Scale with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. Additional analyses were conducted with relapse defined only as a score of 40 or higher on the Children's Depression Rating Scale.Results-Of 168 participants enrolled in acute fluoxetine treatment, 102 were randomly assigned to continuation treatment with fluoxetine (N=50) or placebo (N=52). Of these, 21 participants (42.0%) in the fluoxetine group relapsed, compared with 36 (69.2%) in the placebo group, a significant difference. Similarly, under the stricter definition of relapse, fewer participants in the fluoxetine group relapsed (N=11; 22.0%) than in the placebo group (N=25; 48.1%). Time to relapse was significantly shorter in the placebo group.Conclusions-Continuation treatment with fluoxetine was superior to placebo in preventing relapse and in increasing time to relapse in children and adolescents with major depression.Major depressive disorder is a serious disorder in the pediatric age group, with 2%-8% of children and adolescents afflicted (1,2). Youths with depression often have significant impairment in relationships, school, and work and are at increased risk for substance abuse, attempted and completed suicide, and depression in adulthood (1,3,4). Furthermore, it appears that early-onset major depression may be a more chronic and recurrent disorder than depression that begins in adulthood (1,5). As many as 50%-75% of children with major depression have recurrent episodes (1,3). Recurrence most often occurs within 6-12 months after remission (6)(7)(8). Thus, depression is a serious disorder requiring early intervention. Treatment for major depression may be divided into three phases: acute, continuation, and maintenance treatment. Acute treatment refers to initial treatment designed to achieve response (a significant reduction in depressive symptoms) and ultimately remission (minimal or no symptoms). The goal of treatment is remission, although most randomized controlled trials include response as the primary aim. Continuation treatment follows acute treatment with the goal of preventing relapse of symptoms from the treated episode and consolidating symptom improvement for a longer duration (recovery). Continuation treatment generally lasts 4-9 mon...

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The findings suggest that a randomized clinical trial of Pay Attention! is warranted to investigate its viability as a treatment for attention and executive functioning deficits in ADHD.