Comparison of Efficacy of Fluoxetine with Nortriptyline in Treatment of Major Depression in Children and Adolescents: a double-blind study

The incidence of depression is 0.9% in preschoolers, 1.9% in school age children, and 4.7% in adolescents. Current antidepre ssant treatment of mood disorders in children and adolescents is still in the early phases of being validated with double-blind efficacy studies. In this study the effi cacy of nortriptyline has been compared with fluoxetine in the treatment of major depressi on in children and adolescents. Methods: This was a double-blind clinical trial for 8 weeks, undertaken in the Isfahan Child and Adolescent Guidance outp atient Clinic, Isfahan, Iran . Subjects were 40 outpatients children and adolescents (20 boys and 20 girls) aged 7- 16 years of old who met the Diagnostic and Statistical Manual of Mental Disorders, Forth Edition, for Major Depression. To determine the scores of two groups (Baselin e and after treatment), we used Children Depression Inventory (e DI ). Subjects were randomly assigned to receive nortriptyline 2mg/kglday for 8 weeks (group A) or fluoxetine Irug/kg/day for 8 weeks , (group B). Paired t-test was used to compare the mean of CDI seore of each group before and after treatment. To compare the reduction in the Children Depression Inventory score , an unpaired t-test was used. Results: The mean depression score was 28.9 (SD::I:8.46) before intervention in fluoxetine group while that was 28.4 (SD±8.76) in nortriptyl ine group. Independent t-test showed a significant difference between after treatment mean depression scores in both groups (t=2.97, dt=38 , P=0.004) . The changes at the endpoint compared with baseline were 10.95:: 1:2 .61 and --2.6±0.8 for fluoxetine and nortriptyline, respectively. t- Paired test showed a significant decrease in mean depres sion score in fluoxetine group (P::::;O.OOOI) while that was not significant one in nortriptyline group (P=O.34). At the endpoint (81h week), 10 cases 50% didn t meet the criteria of Major Depression based on DSM-IV in fluoxetine group. Although, it was only 2 cases (10%) for nortriptyline group. Conclusion: The present study suggest that the treatment with fluoxetine in subsiding depression was significantly preferable compared with nortr iptyline. The general conclusion of this study provides evidence in favor of an efficacy advantage of fluoxetine over nortr iptyline in the treatment of depression in ehildren and adolescents.