title: Long-term, open-label venlafaxine extended-release treatment in children and adolescents with major depressive disorder.
abstract: 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.
authors.affiliation: Department of Psychiatry, University of Texas Southwestern Medical Center at Dallas, Dallas, TX, USA.
authors.forename: Graham J
authors.initials: GJ
authors.lastname: Emslie
authors.forename: Paul P
authors.initials: PP
authors.lastname: Yeung
authors.forename: Nadia R
authors.initials: NR
authors.lastname: Kunz
mesh_terms: 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
chemical_list: D018687:Antidepressive Agents, Second-Generation; D003511:Cyclohexanols; D003692:Delayed-Action Preparations; D000069470:Venlafaxine Hydrochloride