The pharmacotherapy of depressive illness in adolescents: An open-label comparison of fluoxetine with imipramine-treated historical controls

Background: This open-label, 6-week clinical trial investigated the respons e to fluoxetine in medication-naive adolescents hospitalized for treatment of major depression. Method: A total of 52 consecutively admitted patients (mean age = 15.7 year s) fulfilling Research Diagnostic Criteria for unipolar, nonpsychotic major depression received fluoxetine monotherapy (mean dose = 33.2 mg/day) in co njunction with psychosocial therapies. Outcome was assessed weekly using th e Hamilton Rating Scale for Depression (HAM-D) and the Clinical Global Impr essions Scale (CGI). Response in this cohort was compared with that observe d in 28 historical controls treated with imipramine (mean dose = 217 mg/day ) who were consecutively admitted patients to this same facility and assess ed in an identical, standardized, open-label protocol. Results: HAM-D scores decreased by a mean of 13.2 in the fluoxetine group c ompared with 10.2 in the group receiving imipramine (p < .002). The mean pe rcentage decreases in HAM-D scores in the 2 groups were 54.3% and 41.4%, re spectively (p < .003). The percentages of patients classified as responders based on a final CGI score of 2 or less were 48.1% and 17.9%, respectively (p = .009). Medications were generally well tolerated with only 5 patients failing to complete the full 6 weeks of their original treatment. Conclusion: In spite of the uncontrolled nature of these data, the findings add to recent evidence suggesting more favorable response to selective ser otonin reuptake inhibitors than tricyclics in adolescents with depressive i llness.