Comparison of Efficacy of Fluoxetine with Nortriptyline in Treatment of Major Depression in Children and Adolescents: a double-blind study
Abstract
Background: The incidence of depression is 0.9% in preschoolers, 1.9% in school age children, and 4.7% in adolescents. Current antidepressant 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 efficacy of nortriptyline has been compared with fluoxetine in the treatment of major depression in children and adolescents.
Methods: This was a double–blind clinical trial for 8 weeks, undertaken in the Isfahan Child and Adolescent Guidance outpatient 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 (Baseline and after treatment), we used Children Depression Inventory (CDI). Subjects were randomly assigned to receive nortriptyline 2mg/kg/day for 8 weeks (group A) or fluoxetine 1mg/kg/day for 8 weeks, (group B). Paired t-test was used to compare the mean of CDI score 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±8.46) before intervention in fluoxetine group while that was 28.4 (SD±8.76) in nortriptyline group. Independent t-test showed a significant difference between after treatment mean depression scores in both groups (t=2.97, df=38, P=0.004). The changes at the endpoint compared with baseline were - 10.95±2.61 and –2.6±0.8 for fluoxetine and nortriptyline, respectively. t- Paired test showed a significant decrease in mean depression score in fluoxetine group (PW0.0001) while that was not significant one in nortriptyline group (P=0.34). At the endpoint (8th 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 nortriptyline. The general conclusion of this study provides evidence in favor of an efficacy advantage of fluoxetine over nortriptyline in the treatment of depression in children and adolescents.
Key words: Major Depressive Disorder, Nortriptyline, Fluoxetine, children and adolescents.
Methods: This was a double–blind clinical trial for 8 weeks, undertaken in the Isfahan Child and Adolescent Guidance outpatient 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 (Baseline and after treatment), we used Children Depression Inventory (CDI). Subjects were randomly assigned to receive nortriptyline 2mg/kg/day for 8 weeks (group A) or fluoxetine 1mg/kg/day for 8 weeks, (group B). Paired t-test was used to compare the mean of CDI score 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±8.46) before intervention in fluoxetine group while that was 28.4 (SD±8.76) in nortriptyline group. Independent t-test showed a significant difference between after treatment mean depression scores in both groups (t=2.97, df=38, P=0.004). The changes at the endpoint compared with baseline were - 10.95±2.61 and –2.6±0.8 for fluoxetine and nortriptyline, respectively. t- Paired test showed a significant decrease in mean depression score in fluoxetine group (PW0.0001) while that was not significant one in nortriptyline group (P=0.34). At the endpoint (8th 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 nortriptyline. The general conclusion of this study provides evidence in favor of an efficacy advantage of fluoxetine over nortriptyline in the treatment of depression in children and adolescents.
Key words: Major Depressive Disorder, Nortriptyline, Fluoxetine, children and adolescents.