Hostname: page-component-848d4c4894-p2v8j Total loading time: 0.001 Render date: 2024-05-19T19:49:27.625Z Has data issue: false hasContentIssue false
  • English
  • Français

Long-Term, Open-Label Venlafaxine Extended-Release Treatment in Children and Adolescents with Major Depressive Disorder

Published online by Cambridge University Press:  07 November 2014

Graham J. Emslie ,
Paul P. Yeung  and
Nadia R. Kunz
Get access Rights & Permissions [Opens in a new window]

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.

Type
Original Research
Information
CNS Spectrums , Volume 12 , Issue 3 , March 2007 , pp. 223 - 233
Copyright
Copyright © Cambridge University Press 2007

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

1.Birmaher, B, Brent, DA, Benson, RS. Summary of the practice parameters for the assessment and treatment of children and adolescents with depressive disorders. American Academy of Child and Adolescent Psychiatry. J Am Acad Child Adolesc Psychiatry. 1998;37:1234–1238.CrossRefGoogle ScholarPubMed
2.Lewinsohn, PM, Rohde, P, Seeley, JR. Major depressive disorder in older adolescents: prevalence, risk factors, and clinical implications. Clin Psychol Rev. 1998;18:765–794.CrossRefGoogle ScholarPubMed
3.Geller, B, Zimerman, B, Williams, M, Bolhofner, K, Craney, JL. Adult psychosocial outcome of prepubertal major depressive disorder. J Am Acad Child Adolesc Psychiatry. 2001;40:673–677.CrossRefGoogle ScholarPubMed
4.Birmaher, B, Ryan, ND, Williamson, DE, et al.Childhood and adolescent depression: a review of the past 10 years. Part I. J Am Acad Child Adolesc Psychiatry. 1996;35:1427–1439.CrossRefGoogle ScholarPubMed
5.Emslie, GJ, Rush, AJ, Weinberg, WA, et al.A double-blind, randomized, placebo-controlled trial of fluoxetine in children and adolescents with depression. Arch Gen Psychiatry. 1997;54:1031–1037.CrossRefGoogle ScholarPubMed
6.Wagner, KD, Ambrosini, P, Rynn, M, et al.Efficacy of sertraline in the treatment of children and adolescents with major depressive disorder: two randomized controlled trials. JAMA. 2003;290:1033–1041.CrossRefGoogle ScholarPubMed
7.Wagner, KD, Robb, AS, Findling, RL, Jin, J, Gutierrez, MM, Heydorn, WE. A randomized, placebo-controlled trial of citalopram for the treatment of major depression in children and adolescents. Am J Psychiatry. 2004;161:1079–1083.CrossRefGoogle ScholarPubMed
8.Wagner, KD, Jonas, J, Findling, RL, Ventura, D, Saikali, K. A double-blind, randomized, placebo-controlled trial of escitalopram in the treatment of pediatric depression. J Am Acad Child Adolesc Psychiatry. 2006;45:280–288.CrossRefGoogle ScholarPubMed
9.Cheung, AH, Emslie, GJ, Mayes, TL. Review of the efficacy and safety of antidepressants in youth depression. J Child Psychol Psychiatry. 2005;46:735–754.CrossRefGoogle ScholarPubMed
10.Nixon, MK, Milin, R, Simeon, JG, Cloutier, P, Spenst, W. Sertraline effects in adolescent major depression and dysthymia: a six-month open trial. J Child Adolesc Psychopharmacol. 2001;11:131–142.CrossRefGoogle ScholarPubMed
11.Rynn, M, Wagner, KD, Donnelly, C, et al.Long-term sertraline treatment of children and adolescents with major depressive disorder. J Child Adolesc Psychopharmacol. 2006;16:103–116.CrossRefGoogle ScholarPubMed
12.Emslie, GJ, Heiligenstein, JH, Hoog, SL, et al.Fluoxetine treatment for prevention of relapse of depression in children and adolescents: a double-blind, placebo-controlled study. J Am Acad Child Adolesc Psychiatry. 2004;43:1397–1405.CrossRefGoogle ScholarPubMed
13.FDA Public Health Advisory: Suicidality in Children and Adolescents Being Treated With Antidepressant Medications. Issued October 15, 2004. Available at: http://www.fda.gov/cder/drug/antidepressants/SSRIPHA200410.htm. Accessed November 14, 2006.Google Scholar
14.Hammad, TA, Laughren, T, Racoosin, J. Suicidality in pediatric patients treated with antidepressant drugs. Arch Gen Psychiatry. 2006;63:332–339.CrossRefGoogle ScholarPubMed
15.Montgomery, SA, Entsuah, R, Hackett, D, Kunz, NR, Rudolph, RL. Venlafaxine versus placebo in the preventive treatment of recurrent major depression. J Clin Psychiatry. 2004;65:328–336.CrossRefGoogle ScholarPubMed
16.Simon, JS, Aguiar, LM, Kunz, NR, Lei, D. Extended-release venlafaxine in relapse prevention for patients with major depressive disorder. J Psychiatr Res. 2004;38:249–257.CrossRefGoogle ScholarPubMed
17.Thase, ME. Efficacy and tolerability of once-daily venlafaxine extended release (XR) in outpatients with major depression. The Venlafaxine XR 209 Study Group. J Clin Psychiatry. 1997;58:393–398.CrossRefGoogle ScholarPubMed
18.Emslie, GJ, Findling, RL, Yeung, PP, Kunz, NR, Li, Y. Venlafaxine ER for the treatment of pediatric patients with depression: results of 2 placebo-controlled trials. J Am Acad Child Adolesc Psychiatry. In press.Google Scholar
19.Hughes, CW, Emslie, GJ, Crismon, ML, et al.The Texas Children's Medication Algorithm Project: report of the Texas Consensus Conference Panel on Medication Treatment of Childhood Major Depressive Disorder. J Am Acad Child Adolesc Psychiatry. 1999;38:1442–1454.CrossRefGoogle ScholarPubMed
20.Kaufman, J, Birmaher, B, Brent, D, et al.Schedule for affective disorders and schizophrenia for school-age children–present and lifetime version (K-SADS-PL): initial reliability and validity data. J Am Acad Child Adolesc Psychiatry. 1997;36:980–988.CrossRefGoogle ScholarPubMed
21.Poznanski, EO, Freeman, LN, Mokros, HB. Children's depression rating scale-revised. Psychopharmacol Bull. 1985;21:979–989.Google Scholar
22.Guy, W, ed. ECDEU Assessment Manual for Psychopharmacology. Rockville, Md: US Department of Health, Education, and Welfare; 1976:217–222. Publication ADM 76-338.Google Scholar
23.Hamilton, M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960;23:56–62.CrossRefGoogle ScholarPubMed
24.Kennard, BD, Silva, S, Vitiello, B, et al.Remission and residual symptoms after acute treatment of adolescents with major depressive disorder. J Am Acad Child Adolesc Psychiatry. 2006;45:1404–1411.CrossRefGoogle Scholar
25.Kusiak, V. Dear Healthcare Professional (venlafaxine). August 22, 2003. Collegeville, Penn: Wyeth Pharmaceuticals.Google Scholar
26.Hammad, TA. and the Center for Drug Evaluation and Research, FDA: Review and Evaluation of Clinical Data, 2004;1–131. Available at: http://www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4065b1-10-TABO8-Hammads-Review.pdf. Accessed November 14, 2006.Google Scholar
27.Findling, RL, McNamara, NK, Stansbrey, RJ, et al.The relevance of pharmacokinetic studies in designing efficacy trials in juvenile major depression. J Child Adolesc Psychopharmacol. 2006;16:131–145.CrossRefGoogle ScholarPubMed
28.Greenhill, L, Vitiello, B, Riddle, M, et al.Review of safety assessment methods used in pediatric psychopharmacology. J Am Acad Child Adolesc Psychiatry. 2003;42:627–633.CrossRefGoogle ScholarPubMed