Am J Psychiatry 1997; 154:668-673
Copyright © 1997 by American Psychiatric Association
Pulse intravenous clomipramine for depressed adolescents: double-blind, controlled trial
FR Sallee, NS Vrindavanam, D Deas-Nesmith, SW Carson and G Sethuraman
Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston 29403, USA. salleefr@musc.edu
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.
