Abstract
BackgroundThe objective of this study was to examine whether fluoxetine was superior to placebo in the acute amelioration of depressive symptomatology in adolescents with depressive illness and a comorbid substance use disorder.MethodsEligible subjects ages 12–17 years with either a current major depressive disorder (MDD) or a depressive disorder that were also suffering from a comorbid substance-related disorder were randomized to receive either fluoxetine or placebo in this single site, 8-week double-blind, placebo-controlled study. The primary outcome analysis was a random effects mixed model for repeated measurements of Children's Depression Rating Scale-Revised (CDRS-R) scores compared between treatment groups across time.ResultsAn interim analysis was performed after 34 patients were randomized. Based on the results of a futility analysis, study enrollment was halted. Twenty-nine males and 5 females were randomized to receive fluoxetine (n = 18) or placebo (n = 16). Their mean age was 16.5 (1.1) years. Overall, patients who received fluoxetine and placebo had a reduction in CDRS-R scores. However, there was no significant difference in mean change in CDRS-R total score in those subjects treated with fluoxetine and those who received placebo (treatment difference = 0.19, S.E. = 0.58, F = 0.14, p = .74). Furthermore, there was not a significant difference in rates of positive urine drug toxicology results between treatment groups at any post-randomization visit (F = 0.22, df = 1, p = 0.65). The main limitation of this study is its modest sample size and resulting low statistical power. Other significant limitations to this study include, but are not limited to, the brevity of the trial, high placebo response rate, limited dose range of fluoxetine, and the inclusion of youth who met criteria for depressive disorders other than MDD.ConclusionFluoxetine was not superior to placebo in alleviating depressive symptoms or in decreasing rates of positive drug screens in the acute treatment of adolescents with depression and a concomitant substance use disorder.
Highlights
The objective of this study was to examine whether fluoxetine was superior to placebo in the acute amelioration of depressive symptomatology in adolescents with depressive illness and a comorbid substance use disorder
Comparison of the primary outcome via mixture model analysis crossed the a priori futility boundary for early stopping with acceptance of the null hypothesis of no treatment difference in mean change in Children's Depression Rating Scale-Revised (CDRS-R) total score
It was calculated that if the study had continued to the planned enrollment of 30 patients per treatment arm, the probability of demonstrating a difference in CDRS-R scores between treatment groups was less than 2% under the alternative hypothesis based on the observed treatment group differences
Summary
The objective of this study was to examine whether fluoxetine was superior to placebo in the acute amelioration of depressive symptomatology in adolescents with depressive illness and a comorbid substance use disorder. An estimated 20%–30% of adolescents with major depressive disorder (MDD) suffer from at least one comorbid substance use disorder [5] These teenagers with both major depression and substance use disorders are significantly more likely to suffer from more pronounced psychosocial dysfunction, greater academic problems, more suicidal behavior and completed suicides than those youth without a substance use disorder [6,7,8,9]. Of concern is the fact that Brent et al [13] found that having a mood disorder and a substance use disorder may put adolescents at a substantial increased risk for suicide. For these reasons, safe and effective treatments for youths who are suffering from comorbid depression and substance use disorders are needed
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