Objective: Major depressive disorder in adolescents is characterized as treatment resistant, but a previous open-label trial of pulse intravenous clomipramine demonstrated rapid relief of depressive symptoms. In 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 treated with pulse clomipramine would exhibit lower scores on the Hamilton Depression Rating Scale at endpoint than would adolescents who received saline and that clomipramine would be superior to saline in terms of antidepressant response.
Method: Sixteen nonsuicidal outpatient adolescents (mean age = 16.2 years, SD = 1.0) who met the DSM-III-R criteria for major depression (score on 21-item Hamilton scale, > or = 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 adolescents who received pulse clomipramine treatment demonstrated significant decreases in Hamilton depression scores from baseline at 6 days but not 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 clomipramine-treated patients and three of the saline-treated patients had drops of 50% or more from baseline in Hamilton depression score.
Conclusions: Pulse clomipramine (200 mg i.v.) is associated with dramatic reduction in depressive symptoms at day 6 after infusion, which is significantly different from the effect of placebo.