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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 RL, Pagano ME, McNamara NK, Stansbrey RJ, Faber JE, Lingler J, Demeter CA, Bedoya D, Reed MD - Child Adolesc Psychiatry Ment Health (2009)

Bottom Line: 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.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Psychiatry, University Hospitals Case Medical Center/Case Western Reserve University, Cleveland, Ohio, USA. robert.findling@uhhospitals.org

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.

No MeSH data available.


Related in: MedlinePlus

Percent of patients with positive drug tests who received fluoxetine or placebo for 8 weeks.
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Figure 3: Percent of patients with positive drug tests who received fluoxetine or placebo for 8 weeks.

Mentions: Fourteen of the 16 of subjects in the placebo group and 13/18 subjects in the fluoxetine group had random urine toxicology tests obtained at either week 3, week 6, or both time points. No between treatment group differences were found in pre-randomization rates of positive drug toxicology (fluoxetine: 83% versus placebo 75%; p = .68). Post-randomization rates of any positive drug toxicology at each study visit are presented in Figure 3. As shown in Figure 3, there was no significant difference in rates of positive drug toxicology between treatment groups at any post- randomization visit (F = 0.22, df = 1, p = 0.65). In addition, over the course of the trial, no alcohol was detected in the serum ethanol levels.


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

Findling RL, Pagano ME, McNamara NK, Stansbrey RJ, Faber JE, Lingler J, Demeter CA, Bedoya D, Reed MD - Child Adolesc Psychiatry Ment Health (2009)

Percent of patients with positive drug tests who received fluoxetine or placebo for 8 weeks.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2666637&req=5

Figure 3: Percent of patients with positive drug tests who received fluoxetine or placebo for 8 weeks.
Mentions: Fourteen of the 16 of subjects in the placebo group and 13/18 subjects in the fluoxetine group had random urine toxicology tests obtained at either week 3, week 6, or both time points. No between treatment group differences were found in pre-randomization rates of positive drug toxicology (fluoxetine: 83% versus placebo 75%; p = .68). Post-randomization rates of any positive drug toxicology at each study visit are presented in Figure 3. As shown in Figure 3, there was no significant difference in rates of positive drug toxicology between treatment groups at any post- randomization visit (F = 0.22, df = 1, p = 0.65). In addition, over the course of the trial, no alcohol was detected in the serum ethanol levels.

Bottom Line: 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.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Psychiatry, University Hospitals Case Medical Center/Case Western Reserve University, Cleveland, Ohio, USA. robert.findling@uhhospitals.org

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.

No MeSH data available.


Related in: MedlinePlus