Absence of cardiovascular adverse effects of sertraline in children and adolescents.
OBJECTIVE
In a 12 week, placebo-controlled, parallel-design, multicenter study of sertraline for obsessive-compulsive disorder in 107 children and 80 adolescents, the authors prospectively assessed cardiovascular effects to doses of sertraline of < or = 200 mg/day.


METHODS
Vital signs (blood pressure and heart rate) and electrocardiograph parameters (ECGs) were systematically evaluated at baseline and again throughout treatment.


RESULTS
There were no clinically significant cardiovascular adverse events in any of the subjects enrolled in the study. Moreover, compared with baseline and placebo, sertraline treatment at an average dose of 167 mg did not result in any clinically meaningful changes in any ECG indices (PR, QRS, and QTc intervals), cardiac rhythm, blood pressure, or heart rate.


CONCLUSIONS
These prospectively derived results support the cardiovascular safety of sertraline at doses up to 200 mg in children and adolescents.
Wilens
T E
TE
Department of Psychiatry, Massachusetts General Hospital, Boston 02114, USA.
Biederman
J
J
March
J S
JS
Wolkow
R
R
Fine
C S
CS
Millstein
R B
RB
Faraone
S V
SV
Geller
D
D
Spencer
T J
TJ
D000293:Adolescent; D000928:Antidepressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001794:Blood Pressure / Q000187:drug effects; D002648:Child; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006439:Hemodynamics / Q000187:drug effects*; D006801:Humans; D008297:Male; D009771:Obsessive-Compulsive Disorder / Q000188:drug therapy*; D020280:Sertraline / Q000009:adverse effects* / Q000627:therapeutic use
D000928:Antidepressive Agents; D020280:Sertraline