Long-term, open-label venlafaxine extended-release treatment in children and adolescents with major depressive disorder

Graham J. Emslie, Paul P. Yeung, Nadia R. Kunz

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Introduction: 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. Conclusion: 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.

Original languageEnglish (US)
Pages (from-to)223-233
Number of pages11
JournalCNS Spectrums
Volume12
Issue number3
StatePublished - Mar 2007

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Major Depressive Disorder
Depression
Hostility
Pharyngitis
Therapeutics
Pediatrics
Suicide
Suicidal Ideation
Venlafaxine Hydrochloride
Hallucinations
Nausea
Abdominal Pain
Antidepressive Agents
Vomiting
Headache
Observation
Safety
Infection
Population

ASJC Scopus subject areas

  • Neuropsychology and Physiological Psychology

Cite this

Long-term, open-label venlafaxine extended-release treatment in children and adolescents with major depressive disorder. / Emslie, Graham J.; Yeung, Paul P.; Kunz, Nadia R.

In: CNS Spectrums, Vol. 12, No. 3, 03.2007, p. 223-233.

Research output: Contribution to journalArticle

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abstract = "Introduction: 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. Conclusion: 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.",
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