PULSE INTRAVENOUS CLOMIPRAMINE FOR DEPRESSED ADOLESCENTS - DOUBLE-BLIND, CONTROLLED TRIAL

Objective: Major depressive disorder in adolescents is characterized a s treatment resistant, but a previous open-label trial of pulse intrav enous clomipramine demonstrated rapid relief of depressive symptoms. I n the present study a single intravenous dose of clomipramine (200 mg) was compared with saline placebo in a randomized controlled trial for depressed adolescents. The hypothesis was that adolescents who were t reated with pulse clomipramine would exhibit lower scores on the Hamil ton Depression Rating Scale at endpoint than would adolescents who rec eived saline and that clomipramine would be superior to saline in term s of antidepressant response. Method: Sixteen nonsuicidal outpatient a dolescents (mean age=16.2 years, SD=1.0) who met the DSM-III-R criteri a for major depression (score on 21-item Hamilton scale, greater than or equal to 18) were randomly assigned to receive either clomipramine (200 mg i.v., N=8) or saline (N=8). Assessments of depression severity were completed 36 hours and 6 days thereafter. Results: The adolescen ts who received pulse clomipramine treatment demonstrated significant decreases in Hamilton depression scores from baseline at 6 days but no t at 36 hours. A similar decrease from baseline was found in Clinical Global Impression severity at 6 days but not 36 hours. Seven of the cl omipramine-treated patients and three of the saline-treated patients h ad drops of 50% or more from baseline in Hamilton depression score. Co nclusions: Pulse clomipramine (200 mg i.v.) is associated with dramati c reduction in depressive symptoms at day 6 after infusion, which is s ignificantly different from the effect of placebo.