TY - JOUR
T1 - Randomized, controlled trial of amitriptyline versus placebo for adolescents with 'treatment-resistant' major depression
AU - Birmaher, Boris
AU - Waterman, G. Scott
AU - Ryan, Neal D.
AU - Perel, James
AU - McNabb, Joanne
AU - Balach, Lisa
AU - Beaudry, Mary Beth
AU - Nasr, Farida N.
AU - Karambelkar, Jagannath
AU - Elterich, Gertrude
AU - Quintana, Humberto
AU - Williamson, Douglas E.
AU - Rao, Uma
PY - 1998/5
Y1 - 1998/5
N2 - Objective: To assess the response to a serotonergic/noradrenergic tricyclic antidepressant, amitriptyline (AMI), in a group of adolescents with treatment-resistant major depressive disorder (MDD). Method: Twenty-seven depressed adolescents admitted to a state hospital underwent a 10-week randomized, controlled trial with a flexible dose of AMI or placebo. Results: There were no differences between patients taking AMI (n = 13) and placebo (n = 14). Both treatment groups showed approximately 70% to 80% improvement on the clinical outcome measurements, and 65% to 70% showed functional improvement. At the end of the protocol, 30% of patients still fulfilled criteria for MDD and had impaired functioning. Patients taking AMI experienced significantly more dry mouth and tachycardia. The final AMI dose was 173.1 mg/day ± 56.3 mg/day; blood levels were 226.2 ng/mL ± 80.8 ng/mL. Conclusions: No significant differences were found between AMI and placebo, in part because of the high placebo response rate. Although both treatment groups showed substantial response, at the end of treatment a substantial proportion of patients still had MDD or subsyndromal symptoms of depression. This and other studies of tricyclic antidepressants question the use of this medication as first-line treatment for youths with MDD.
AB - Objective: To assess the response to a serotonergic/noradrenergic tricyclic antidepressant, amitriptyline (AMI), in a group of adolescents with treatment-resistant major depressive disorder (MDD). Method: Twenty-seven depressed adolescents admitted to a state hospital underwent a 10-week randomized, controlled trial with a flexible dose of AMI or placebo. Results: There were no differences between patients taking AMI (n = 13) and placebo (n = 14). Both treatment groups showed approximately 70% to 80% improvement on the clinical outcome measurements, and 65% to 70% showed functional improvement. At the end of the protocol, 30% of patients still fulfilled criteria for MDD and had impaired functioning. Patients taking AMI experienced significantly more dry mouth and tachycardia. The final AMI dose was 173.1 mg/day ± 56.3 mg/day; blood levels were 226.2 ng/mL ± 80.8 ng/mL. Conclusions: No significant differences were found between AMI and placebo, in part because of the high placebo response rate. Although both treatment groups showed substantial response, at the end of treatment a substantial proportion of patients still had MDD or subsyndromal symptoms of depression. This and other studies of tricyclic antidepressants question the use of this medication as first-line treatment for youths with MDD.
KW - Adolescents
KW - Antidepressants
KW - Major depressive disorder
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U2 - 10.1097/00004583-199805000-00015
DO - 10.1097/00004583-199805000-00015
M3 - Article
C2 - 9585655
AN - SCOPUS:0031978918
SN - 0890-8567
VL - 37
SP - 527
EP - 535
JO - Journal of the American Academy of Child Psychiatry
JF - Journal of the American Academy of Child Psychiatry
IS - 5
ER -