E. Tierney et al., SERTRALINE FOR MAJOR DEPRESSION IN CHILDREN AND ADOLESCENTS - PRELIMINARY CLINICAL-EXPERIENCE, Journal of child and adolescent psychopharmacology, 5(1), 1995, pp. 13-27
Objective: To evaluate the therapeutic and adverse effects of sertrali
ne in children and adolescents with major depressive disorder (MDD). M
ethod: Retrospective chart reviews were conducted on 33 youths (ages 8
-18 years) treated for MDD with sertraline and no other psychotropic m
edication. Focusing on the interval from 2 to 10 weeks of treatment (w
hen therapeutic changes were anticipated), clinical changes were asses
sed utilizing the Clinical Global Impression (CGI) subscales for sever
ity of illness (modified to reflect severity of depressive illness) in
21 patients and for global improvement in 17 patients. Adverse effect
s were assessed in all 33 patients. Results: By the tenth week of trea
tment, the mean scores for severity of depressive illness changed sign
ificantly from 5.8 to 3.4 (6 = severely ill, 3 = mildly ill) and globa
l improvement scores indicated that 11 of 17 patients (65%) improved m
uch or very much. Older children improved to a greater degree. Mean do
se was 1.6 mg/kg or 100 mg (range 25-200 mg) daily. No data were colle
cted on which symptoms may have responded. Adverse effects were experi
enced by 16 of 33 patients, and 8 discontinued sertraline due to adver
se effects. Seven patients (21%), including 4 of the 8 discontinuers,
experienced behavioral side effects, whose onset clustered within the
first 2 weeks and at 3 months of treatment. Two patients developed man
ia during sertraline treatment (one at 3 days, other at 94 days), and
five developed other types of behavioral activation. No patient showed
a worsening of depressive symptoms or an onset of suicidality or viol
ence. Fatigue and sedation appeared to resolve spontaneously. Conclusi
on: These preliminary and uncontrolled clinical findings suggest that
some children and adolescents with MDD may respond to sertraline, but
adverse behavioral effects may be common.