The short-term safety and efficacy of fluoxetine in depressed adolescents with alcohol and cannabis use disorders: A pilot randomized placebo-controlled trial

Robert L Findling, Maria E. Pagano, Nora K. McNamara, Robert J. Stansbrey, Jon E. Faber, Jacqui Lingler, Christine A. Demeter, Denise Bedoya, Michael D. Reed

Research output: Contribution to journalArticle

Abstract

Background: 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. Methods: Eligible 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. Results: An 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. Conclusion: Fluoxetine 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.

Original languageEnglish (US)
Article number11
JournalChild and Adolescent Psychiatry and Mental Health
Volume3
DOIs
StatePublished - Mar 19 2009
Externally publishedYes

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Fluoxetine
Cannabis
Randomized Controlled Trials
Placebos
Alcohols
Safety
Depression
Substance-Related Disorders
Major Depressive Disorder
Depressive Disorder
Medical Futility
Therapeutics
Random Allocation
Pharmaceutical Preparations
Sample Size
Toxicology
Urine

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Psychiatry and Mental health

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The short-term safety and efficacy of fluoxetine in depressed adolescents with alcohol and cannabis use disorders : A pilot randomized placebo-controlled trial. / Findling, Robert L; Pagano, Maria E.; McNamara, Nora K.; Stansbrey, Robert J.; Faber, Jon E.; Lingler, Jacqui; Demeter, Christine A.; Bedoya, Denise; Reed, Michael D.

In: Child and Adolescent Psychiatry and Mental Health, Vol. 3, 11, 19.03.2009.

Research output: Contribution to journalArticle

Findling, Robert L ; Pagano, Maria E. ; McNamara, Nora K. ; Stansbrey, Robert J. ; Faber, Jon E. ; Lingler, Jacqui ; Demeter, Christine A. ; Bedoya, Denise ; Reed, Michael D. / The short-term safety and efficacy of fluoxetine in depressed adolescents with alcohol and cannabis use disorders : A pilot randomized placebo-controlled trial. In: Child and Adolescent Psychiatry and Mental Health. 2009 ; Vol. 3.
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AU - Stansbrey, Robert J.

AU - Faber, Jon E.

AU - Lingler, Jacqui

AU - Demeter, Christine A.

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AU - Reed, Michael D.

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