Limits...
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

Mean change from baseline for fluoxetine- and placebo-treated patients on the Children's Depression Rating Scale-Revised. *Random effects regression model indicated that there was no significant treatment by visit interaction (p = .14).
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC2666637&req=5

Figure 2: Mean change from baseline for fluoxetine- and placebo-treated patients on the Children's Depression Rating Scale-Revised. *Random effects regression model indicated that there was no significant treatment by visit interaction (p = .14).

Mentions: Placebo-treated patients experienced a greater mean reduction in CDRS-R score than fluoxetine-treated patients at end of study participation (-4.23, 95% confidence interval [CI], -12.95 to 4.49). Although both groups had a reduction in CDRS-R scores, compared with placebo, fluoxetine treatment in this trial was not associated with greater improvement in CDRS-R. More specifically, in the random effects mixture model for repeated measurements, there was no significant treatment by visit interaction (p = .14), indicating no difference between treatment groups in mean change in CDRS-R score at any week during the trial. As shown in Figure 2, those subjects that received placebo showed a greater decrease in CDRS-R scores from baseline beginning at week 5 in comparison to those subjects that received fluoxetine. Using recommended methods [45], primary outcome results remained constant when the extreme CDRS-R score observed (most severe/least severe) was assumed for these 3 fluoxetine-treated patients.


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)

Mean change from baseline for fluoxetine- and placebo-treated patients on the Children's Depression Rating Scale-Revised. *Random effects regression model indicated that there was no significant treatment by visit interaction (p = .14).
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 2: Mean change from baseline for fluoxetine- and placebo-treated patients on the Children's Depression Rating Scale-Revised. *Random effects regression model indicated that there was no significant treatment by visit interaction (p = .14).
Mentions: Placebo-treated patients experienced a greater mean reduction in CDRS-R score than fluoxetine-treated patients at end of study participation (-4.23, 95% confidence interval [CI], -12.95 to 4.49). Although both groups had a reduction in CDRS-R scores, compared with placebo, fluoxetine treatment in this trial was not associated with greater improvement in CDRS-R. More specifically, in the random effects mixture model for repeated measurements, there was no significant treatment by visit interaction (p = .14), indicating no difference between treatment groups in mean change in CDRS-R score at any week during the trial. As shown in Figure 2, those subjects that received placebo showed a greater decrease in CDRS-R scores from baseline beginning at week 5 in comparison to those subjects that received fluoxetine. Using recommended methods [45], primary outcome results remained constant when the extreme CDRS-R score observed (most severe/least severe) was assumed for these 3 fluoxetine-treated patients.

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