Long-term, open-label venlafaxine extended-release treatment in children and adolescents with major depressive disorder.
BACKGROUND
Because major depressive disorder (MDD) is often chronic and recurrent, even pediatric patients who are treated successfully during an acute episode may need longer-term treatment. Yet, data on long-term treatment with antidepressants in pediatric MDD are limited.


OBJECTIVE
To evaluate long-term effectiveness and safety of treatment with venlafaxine extended-release (ER) in children and adolescents with MDD.


METHODS
Subjects (n=86) 7-17 years of age with MDD entered a multicenter, open-label study of flexible-dose venlafaxine ER for 6 weeks of acute treatment, followed by continuation treatment for up to 6 months total treatment. The primary efficacy variable was the Children's Depression Rating Scale-Revised (CDRS-R) total score (intent-to-treat population).


RESULTS
Mean CDRS-R total score decreased from 60.1+/-10.0 at baseline to 36.3+/-13.1 at week 6, and to 33.8+/-15.0 at 6 months (last observation carried forward). Among completers (n=36), the mean CDRS-R total score was 24.3+/-7.6 at the end of 6 months of treatment. The most frequent treatment-emergent adverse events were headache (53%), nausea (26%), infection (24%), abdominal pain (22%), vomiting (21%), and pharyngitis (19%). Fifteen (17%) participants discontinued due to adverse events, 9 of whom did so within the first 6 weeks. Serious adverse events (suicide attempt [two], hostility [two], hallucinations, depression, and pharyngitis) occurred in seven patients. There were no suicides.


CONCLUSIONS
Most improvement with venlafaxine ER occurs during the first 6 weeks of treatment. Prescribers should be alert to signs of suicidal ideation and hostility in pediatric patients.
Emslie
Graham J
GJ
Department of Psychiatry, University of Texas Southwestern Medical Center at Dallas, Dallas, TX, USA.
Yeung
Paul P
PP
Kunz
Nadia R
NR
D000293:Adolescent; D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use*; D002648:Child; D003511:Cyclohexanols / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D003865:Major Depressive Disorder / Q000188:drug therapy* / Q000523:psychology*; D005260:Female; D006801:Humans; D008297:Male; D012720:Severity of Illness Index; D013997:Time Factors; D000069470:Venlafaxine Hydrochloride
D018687:Antidepressive Agents, Second-Generation; D003511:Cyclohexanols; D003692:Delayed-Action Preparations; D000069470:Venlafaxine Hydrochloride