Randomized, controlled trial of amitriptyline versus placebo for adolescents with "treatment-resistant" major depression.
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).


METHODS
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 of 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.
Birmaher
B
B
Division of Child Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, USA. birmaherb@msx.upmc.edu
Waterman
G S
GS
Ryan
N D
ND
Perel
J
J
McNabb
J
J
Balach
L
L
Beaudry
M B
MB
Nasr
F N
FN
Karambelkar
J
J
Elterich
G
G
Quintana
H
H
Williamson
D E
DE
Rao
U
U
D000293:Adolescent; D000639:Amitriptyline / Q000009:adverse effects / Q000627:therapeutic use*; D000929:Antidepressive Agents, Tricyclic / Q000009:adverse effects / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male
D000929:Antidepressive Agents, Tricyclic; D000639:Amitriptyline