Paula D. Riggs, MD, Susan K. Mikulich-Gilbertson, PhD, Robert D. Davies, MD, Michelle Lohman, RN, Constance Klein, MSW, Shannon K. Stover (all authors from the University of Colorado, OV Node)

View article (free online)

This article reports on the controlled efficacy study on which protocol CTN-0028 is closely modeled. The objective of this study was to evaluate the effect of fluoxetine hydrochloride vs. placebo on major depressive disorder, substance use disorder (SUD), and conduct disorder (CD) in adolescents receiving cognitive behavioral therapy (CBT) for SUD. Recruited from the community were 126 adolescents (aged 13-19 years) meeting diagnostic criteria for current major depressive disorder, lifetime CD, and at least 1 nontobacco SUD. The adolescents were randomly assigned to either sixteen weeks of fluoxetine hydrochloride (20mg/d) with CBT, or placebo with CBT. The researchers found that fluoxetine combined with CBT had greater efficacy than did placebo and CBT, according to changes on the Childhood Depression Rating Scale-Revised (effect size 0.78), but not on the Clinical Global Impression Improvement treatment response (76% and 67%, respectively). There was an overall decrease in self-reported substance use and CD symptoms, but neither difference between groups was statistically significant. The proportion of substance-free weekly urine screen results was higher in the placebo-CBT group than in the fluoxetine-CBT group. In conclusion, fluoxetine and CBT had greater efficacy than did placebo and CBT on one, but not both, depression measures, and was not associated with greater decline in self-reported substance use or CD symptoms. The CBT may have contributed to higher-than-expected treatment response and mixed efficacy findings, despite its focus on SUD.

The results of this study lend strong support for CTN-0028, which also aims to recruit a difficult comorbid adolescent target population (ADHD and SUD) and focuses on the implementation/integrity of comprehensive psychiatric evaluation and treatment of co-occurring disorders in "real world" adolescent substance treatment programs. (Article (Peer-reviewed), PDF, English, 2007)

Keywords: Adolescents | Behavior therapy | Childhood Depression Rating Scale - Revised | Clinical Global Impressions Scale (CGI) | Community health services | Co-occurring disorders | Pharmacological therapy | Screening and assessment instruments | Archives of Pediatric & Adolescent Medicine (journal)

Document No: 252

Submitted by Paula Riggs, MD, Principal Investigator, CTN-0028, 11/6/2007.