Skip to main content
Mijn bibliotheek
Shop
Nieuws Boeken Tijdschriften Toetsvragen Web-tv Video Audio
Tips voor Mijn BSL
Inloggen
Top
Quality of Life Research
Gepubliceerd in:

01-06-2011

Effect of atomoxetine on quality of life and family burden: results from a randomized, placebo-controlled, double-blind study in children and adolescents with ADHD and comorbid oppositional defiant or conduct disorder

Auteurs: Peter M. Wehmeier, Alexander Schacht, Ralf W. Dittmann, Karin Helsberg, Christian Schneider-Fresenius, Martin Lehmann, Monika Bullinger, Ulrike Ravens-Sieberer

Gepubliceerd in: Quality of Life Research | Uitgave 5/2011

Log in om toegang te krijgen
share
DELEN

Deel dit onderdeel of sectie (kopieer de link)

  • Optie A:
    Klik op de rechtermuisknop op de link en selecteer de optie “linkadres kopiëren”
  • Optie B:
    Deel de link per e-mail
    Link delen
publish
Publiceer nu

Abstract

Purpose

To evaluate the effect of atomoxetine on quality of life (QoL) and family burden in children and adolescents with attention deficit/hyperactivity disorder (ADHD) and comorbid oppositional defiant (ODD) or conduct disorder (CD).

Methods

This secondary analysis was based on a randomized, double-blind, 9-week study of atomoxetine (target dose 1.2 mg/kg body weight) versus placebo. The study included 180 patients (atomoxetine 121, placebo 59), aged 6–17 years. QoL was measured using the KINDL-R questionnaire. The total score encompasses six dimensions (or subscales) measuring QoL in terms of “physical well-being”, “emotional well-being”, “self-esteem”, “friends”, “family”, and “school”. Family burden of illness was measured using the FaBel questionnaire.

Results

With atomoxetine, the KINDL-R total score improved significantly (P = 0.021) more than with placebo. This improvement also applied to the subscales except for “physical well-being” (opposite effect) and “school” (no effect). No significant treatment group differences were seen on the FaBel questionnaire. No differences were found between the fast and slow titration groups in terms of ADHD, ODD, and disruptive behavior severity. Furthermore, no such differences were observed for QoL and family burden.

Conclusions

This study suggests positive effects of atomoxetine on quality of life, as measured by the KINDL-R scores on emotional well-being, self-esteem, friends and family, in children and adolescents with ADHD and comorbid ODD/CD. No significant treatment effects were seen on family burden, as measured by FaBel total score.
vorige artikel Prevalence of complementary/alternative medicines (CAMs) in a cancer population in northern Italy receiving antineoplastic treatments and relationship with quality of life and psychometric features
volgende artikel Predictors of quality of life in carers for people with a progressive neurological illness: a longitudinal study
Literatuur
1.
American Psychiatric Association (APA). (2000). Diagnostic and statistical manual of mental disorders (4th Edn), Text Revision (DSM-IV-TR). Washington, DC: American Psychiatric Association.
2.
Biederman, J., & Faraone, S. V. (2005). Attention-deficit hyperactivity disorder. Lancet, 366, 237–248.PubMedCrossRef
3.
Escobar, R., Montoya, A., Polavieja, P., Cardo, E., Artigas, J., Hervas, A., et al. (2009). Evaluation of patients’ and parents’ quality of life in a randomized placebo-controlled atomoxetine study in attention-deficit/hyperactivity disorder. Journal of Child and Adolescent Psychopharmacology, 19(3), 253–263.PubMedCrossRef
4.
Johnston, C., & Mash, E. J. (2001). Families of children with attention-deficit/hyperactivity disorder: Review and recommendations for future research. Clinical Child and Family Psychology Review, 4, 183–207.PubMedCrossRef
5.
Klassen, A. F., Miller, A., & Fine, S. (2004). Health-related quality of life in children and adolescents who have a diagnosis of attention-deficit/hyperactivity disorder. Pediatrics, 114, e541–e547.PubMedCrossRef
6.
Matza, L. S., Rentz, A. M., Secnik, K., Swensen, A. R., Revicki, D. A., Michelson, D., et al. (2004). The link between health-related quality of life and clinical symptoms among children with attention-deficit hyperactivity disorder. JJournal of Developmental and Behavioral Paediatrics, 25, 166–174.CrossRef
7.
Nijmeijer, J. S., Minderaa, R. B., Buitelaar, J. K., Mulligan, A., Hartman, C. A., & Hoekstra, P. J. (2008). Attention-deficit/hyperactivity disorder and social dysfunctioning. Clinical Psychology Review, 28(4), 692–708.PubMedCrossRef
8.
Riley, A. W., Spiel, G., Coghill, D., Döpfner, M., Falissard, B., Lorenzo, M. J., et al. (2006). Factors related to Health-Related Quality of Life (HRQoL) among children with ADHD in Europe at entry into treatment. European Child and Adolescent Psychiatry, 15(Suppl 1), i38–i45. (published online).PubMedCrossRef
9.
Sawyer, M. G., Whaites, L., Rey, J. M., Hazell, P. L., Graetz, B. W., & Baghurst, P. (2002). Health-related quality of life of children and adolescents with mental disorders. Journal of the American Academy of Child and Adolescent Psychiatry, 41, 530–537.PubMedCrossRef
10.
Strine, T. W., Lesesne, C. A., Okoro, C. A., McGuire, L. C., Chapman, D. P., Balluz, L. S., et al. (2006). Emotional and behavioral difficulties and impairments in everyday functioning among children with a history of attention-deficit/hyperactivity disorder. Public Health Research Practice and Policy, 3, 1–10.
11.
August, G. J., Realmuto, G. M., MacDonald, A. W., III, Nugent, S. M., & Crosby, R. (1996). Prevalence of ADHD and comorbid disorders among elementary school children screened for disruptive behavior. Journal of Abnormal Child Psychology, 24(5), 571–595.PubMedCrossRef
12.
Jensen, P. S., Hinshaw, S. P., Kraemer, H. C., Lenora, N., Newcorn, J. H., Abikoff, H. B., et al. (2001). ADHD comorbidity findings from the MTA study: Comparing comorbid subgroups. Journal of the American Academy of Child and Adolescent Psychiatry, 40(2), 147–158.PubMedCrossRef
13.
Biederman, J., Spencer, T. J., Newcorn, J. H., Gao, H., Milton, D. R., Feldman, P. D., et al. (2007). Effect of comorbid symptoms of oppositional defiant disorder on responses to atomoxetine in children with ADHD: A meta-analysis of controlled clinical trial data. Psychopharmacology (Berl), 190, 31–41.CrossRef
14.
Turgay, A. (2005). Treatment of comorbidity in conduct disorder with attention-deficit hyperactivity disorder (ADHD). Essential Psychopharmacology, 6, 277–290.PubMed
15.
Kuhne, M., Schachar, R., & Tannock, R. (1997). Impact of comorbid oppositional or conduct problems on attention-deficit hyperactivity disorder. Journal of the American Academy of Child and Adolescent Psychiatry, 36(12), 1715–1725.PubMedCrossRef
16.
MTA Cooperative Group. (1999). A 14-month randomized clinical trial of treatment strategies for attention-deficit/hyperactivity disorder. The MTA Cooperative Group. Multimodal Treatment Study of Children with ADHD. Archives of General Psychiatry, 56, 1073–1186.CrossRef
17.
MTA Cooperative Group. (1999). Moderators and mediators of treatment response for children with attention-deficit/hyperactivity disorder: The Multimodal Treatment Study of children with Attention-deficit/hyperactivity disorder. Archives of General Psychiatry, 56, 1088–1096.CrossRef
18.
Gadow, K. D., Nolan, E. E., Sverd, J., Sprafkin, J., & Schneider, J. (2008). Methylphenidate in children with oppositional defiant disorder and both comorbid chronic multiple tic disorder and ADHD. Journal of Child Neurology, 23, 981–990.PubMedCrossRef
19.
Klein, R. G., Abikoff, H., Klass, E., Ganeles, D., Seese, L. M., & Pollack, S. (1997). Clinical efficacy of methylphenidate in conduct disorder with and without attention deficit hyperactivity disorder. Archives of General Psychiatry, 54, 1073–1080.PubMed
20.
Sinzig, J., Döpfner, M., Lehmkuhl, G., German Methylphenidate Study Group, Uebel, H., Schmeck, K., et al. (2007). Long-acting methylphenidate has an effect on aggressive behavior in children with attention-deficit/hyperactivity disorder. Journal of Child and Adolescent Psychopharmacology, 17, 421–432.PubMedCrossRef
21.
Spencer, T. J., Abikoff, H. B., Connor, D. F., Biederman, J., Pliszka, S. R., Boellner, S., et al. (2006). Efficacy and safety of mixed amphetamine salts extended release (adderall XR) in the management of oppositional defiant disorder with or without comorbid attention-deficit/hyperactivity disorder in school-aged children and adolescents: A 4-week, multicenter, randomized, double-blind, parallel-group, placebo-controlled, forced-dose-escalation study. Clinical Therapeutics, 28(3), 402–418.PubMedCrossRef
22.
Bangs, M. E., Hazell, P., Danckaerts, M., Hoare, P., Coghill, D. R., Wehmeier, P. M., et al. (2008). Atomoxetine ADHD/ODD Study Group: Atomoxetine for the treatment of attention-deficit/hyperactivity disorder and oppositional defiant disorder. Pediatrics, 121, e314–e320.PubMedCrossRef
23.
Dell’Agnello, G., Maschietto, D., Pancotto, A., Calamoneri, F., Masi, G., Curatolo, P., et al. (2009). Atomoxetine hydrochloride in the treatment of children and adolescents with attention-deficit/hyperactivity disorder and comorbid oppositional defiant disorder: Results from a placebo-controlled Italian study. European Neuropsychopharmacology, 19, 822–834.PubMedCrossRef
24.
Dittmann, R. W., Schacht, A., Helsberg, K., Schneider-Fresenius, C., Lehmann, M., Lehmkuhl, G., Wehmeier, P. M. (2009a). Randomisierte, plazebokontrollierte Doppelblindstudie zur Wirksamkeit und Verträglichkeit von Atomoxetin (ATX) bei Kindern und Jugendlichen mit ADHS und oppositionellem Trotzverhalten bzw. Störung des Sozialverhaltens. In Frank Schneider und Michael Grözinger (Eds.), Psychiatric disorders through lifespan. abstract book of the DGPPN congress 2009, 25–28 November 2009 (p. 230). Germany: ICC Berlin. doi:10.​3287/​dgppn.​2009.​1.
25.
Bullinger, M., Schmidt, S., Petersen, C., Erhart, M., & Ravens-Sieberer, U. (2007). Methodological challenges and potentials of health-related quality of life evaluation in children with chronic health conditions under medical health care. Medizinische Klinik (Munich), 102(9), 734–745.CrossRef
26.
Ravens-Sieberer, U., Schmidt, S., Gosch, A., Erhart, M., Petersen, C., Bullinger, M. (2007). Measuring subjective health in children and adolescents: Results of the European KIDSCREEN/DISABKIDS Project. Psycho-Social Medicine, 12(4), 1–13.
27.
Döpfner, M., & Lehmkuhl, G. (2000). DISYPS-KJ: Diagnostik-System für psychische Störungen im Kindes- und Jugendalter nach ICD-10 und DSM-IV (2nd ed.). Switzerland: Hans Huber, Bern.
28.
Swanson, J. M., Kraemer, H. C., Hinshaw, S. P., Arnold, L. E., Conners, C. K., Abikoff, H. B., et al. (2001). Clinical relevance of the primary findings of the MTA: Success rates based on severity of ADHD and ODD symptoms at the end of treatment. Journal of the American Academy of Child and Adolescent Psychiatry, 40, 168–179.PubMedCrossRef
29.
Bullinger, M., Brütt, A. L., Erhart, M., Ravens-Sieberer, U., & BELLA Study Group. (2008). Psychometric properties of the KINDL-R questionnaire: Results of the BELLA study. European Child and Adolescence Psychiatry, 17(Suppl 1), 125–132.CrossRef
30.
Ravens-Sieberer, U., & Bullinger, M. (2003). Der Kindl-R Fragebogen zur Erfassung der gesundheitsbezogenen Lebensqualität bei Kindern und Jugendlichen—Revidierte Form. In J. Schumacher, A. Klaiberg, & E. Brähler (Eds.), Diagnostische Verfahren zu Lebensqualität und Wohlbefinden (pp. 184–188). Göttingen: Hogrefe.
31.
32.
Ravens-Sieberer, U., & Bullinger, M. (1998). Assessing health-related quality of life in chronically ill children with the German KINDL: First psychometric and content analytical results. Quality of Life Research, 7(5), 399–407.PubMedCrossRef
33.
Ravens-Sieberer, U., Morfeld, M., Stein, R. E., Jessop, D. J., Bullinger, M., & Thyen, U. (2001). The testing and validation of the German version of the impact on family scale in families with children with disabilities. Psychotherapie, Psychosomatik, Medizinische Psychologie, 51(9–10), 384–393.PubMedCrossRef
34.
Stein, R. E. K., & Riessman, C. K. (1980). The development of an Impact-on-Family Scale: Preliminary findings. Medical Care, 18, 465–472.PubMedCrossRef
35.
Stein, R. E., & Jessop, D. J. (2003). The impact on family scale revisited: Further psychometric data. Journal of Developmental and Behavioral Paediatrics, 24(1), 9–16.CrossRef
36.
Williams, A. R., Piamjariyakul, U., Williams, P. D., Bruggeman, S. K., & Cabanela, R. L. (2006). Validity of the revised Impact on Family (IOF) scale. Journal of Pediatrics, 149, 257–261.PubMedCrossRef
37.
Guy, W. (1976). ECDEU Assessment manual for psychopharmacology. Washington DC, US Department of Health, Education and Welfare, 338, 534–537.
38.
National Institutes of Mental Health. (1985). Clinical global impressions. Psychopharmacology Bulletin, 21, 839–943.
39.
Achenbach, T. M. (1991). Manual for the child behavior checklist/4–18 and 1991 profile. Burlington, VT: University of Vermont, Department of Psychiatry.
40.
Perwien, A. R., Faries, D. E., Kratochvil, C. J., et al. (2004). Improvement in health-related quality of life in children with ADHD: An analysis of placebo controlled studies of atomoxetine. Journal of Developmental and Behavioral Paediatrics, 25, 264–271.CrossRef
41.
Perwien, A. R., Kratochvil, C. J., Faries, D. E., et al. (2006). Atomoxetine treatment in children and adolescents with attention-deficit hyperactivity disorder: What are the long-term health-related quality-of-life outcomes? Journal of Child and Adolescent Psychopharmacology, 16, 713–724.PubMedCrossRef
42.
Prasad, S., Harpin, V., Poole, L., et al. (2007). A multi-centre, randomized, open-label study of atomoxetine compared with standard current therapy in UK children and adolescents with attention-deficit/hyperactivity disorder (ADHD). Current Medical Research and Opinion, 23, 379–394.PubMedCrossRef
43.
Svanborg, P., Thernlund, G., Gustafsson, P. A., Hägglöf, B., Schacht, A., & Kadesjö, B. (2009). Atomoxetine improves patient and family coping in attention deficit/hyperactivity disorder: A randomized, double-blind, placebo-controlled study in Swedish children and adolescents. European Child and Adolescent Psychiatry, 18(12), 725–735.PubMedCrossRef
44.
Svanborg, P., Thernlund, G., Gustafsson, P. A., Hägglöf, B., Poole, L., & Kadesjö, B. (2009). Efficacy and safety of atomoxetine as add-on to psychoeducation in the treatment of attention deficit/hyperactivity disorder: A randomized, double-blind, placebo-controlled study in stimulant-naïve Swedish children and adolescents. European Child and Adolescent Psychiatry, 18(4), 240–249.PubMedCrossRef
45.
Steinhausen, H. C., Nøvik, T. S., Baldursson, G., Curatolo, P., Lorenzo, M.J., Rodrigues Pereira, R., Ralston, S. J., Rothenberger, A., ADORE Study Group. (2006). Co-existing psychiatric problems in ADHD in the ADORE cohort. European Child and Adolescent Psychiatry, 15(Suppl 1), I25–I29.
46.
Campbell, T. C. (2005). An introduction to clinical significance. An alternative index of intervention effect for group experimental designs. Journal of Early Intervention, 27(3), 210–227.CrossRef
47.
Riley, A. W., Forrest, C., Starfield, B., Rebok, G., Green, B., Robertson, J. Baltimore, M. D. (2001). Child Health and Illness Profile-Child Edition (CHIP-CE). Baltimore: The Johns Hopkins University.
48.
Etkin, A., Egner, T., Peraza, D. M., Kandel, E. R., & Hirsch, J. (2006). Resolving emotional conflict: A role for the rostral anterior cingulate cortex in modulating activity in the amygdala. Neuron, 51(6), 871–882.PubMedCrossRef
49.
Ochsner, K. N., & Gross, J. J. (2005). The cognitive control of emotion. Trends in Cognitive Sciences, 9(5), 242–249.PubMedCrossRef
50.
Landgraf, J., Abetz, L., & Ware, J. (1996). Child Health Questionnaire (CHQ): A users manual. Boston: Integrated Therapeutics Group.
51.
Dittmann, R. W., Wehmeier, P. M., Lehmann, M., Schacht, A., Helsberg, K., Lehmkuhl, G. (2007). Behandlung von ADHS bei Jugendlichen in Deutschland. Offene Studie zur Effektivität und Verträglichkeit von Atomoxetin aus Sicht von Arzt, Eltern und Patient. In B. Herpertz-Dahlmann (Ed.), Prävention, Früherkennung, Entwicklungsneurobiologie (pp. 226–227). Berlin: Medizinisch Wissenschaftliche Verlagsgesellschaft.
52.
Dittmann, R. W., Wehmeier, P. M., Schacht, A., Lehmann, M., & Lehmkuhl, G. (2009). Verändert sich das Selbstwertgefühl von Jugendlichen mit ADHS in ihrer Selbsteinschätzung unter einer medikamentösen Behandlung mit Atomoxetin? In M. Schulte-Markwort (Ed.), Psychosomatik—Die Kinder- und Jugendpsychiatrie als interdisziplinäres Fach (p. 111). Berlin: Medizinisch Wissenchaftliche Verlagsgesellschaft.
53.
Schacht, A., Escobar, R., Wagner, T., Wehmeier, P. M. (2009). Effect of atomoxetine on quality of life and its correlations with ADHD core symptoms: A meta-analysis of children and adolescents atomoxetine trials from Europe and Canada. In Poster, international congress of the World Psychiatric Association (WPA), Florence,1st–4th April.
54.
Dittmann, R. W., Wehmeier, P. M., Schacht, A., Lehmann, M., & Lehmkuhl, G. (2009). Self-esteem in adolescent patients with attention-deficit/hyperactivity disorder during open-label atomoxetine treatment: Psychometric evaluation of the Rosenberg Self-Esteem Scale and clinical findings. Attention Deficit and Hyperactivity Disorders, 1, 187–200.PubMedCrossRef
55.
Rosenberg, M. (1965). Society and the adolescent self-image. Princeton, NJ: Princeton University Press.
56.
Landgraf, J. M., Rich, M., & Rappaport, L. (2002). Measuring quality of life in children with attention-deficit/hyperactivity disorder and their families development and evaluation of a new tool. Archives of Pediatrics and Adolescent Medicine, 156(4), 384–391.PubMed
57.
Riley, A. W., Lyman, L. M., Spiel, G., Döpfner, M., Lorenzo, M. J., & Ralston, S. J. (2006). The family strain index (FSI). Reliability, validity, and factor structure of a brief questionnaire for families of children with ADHD. European Child and Adolescent Psychiatry, 15(Suppl 1), i72–i78. (published online).PubMedCrossRef
58.
Kelsey, D. K., Sumner, C. R., Casat, C. D., Coury, D. L., Quintana, H., Saylor, K. E., et al. (2004). Once-daily atomoxetine treatment for children with attention-deficit/hyperactivity disorder, including an assessment of evening and morning behavior: A double-blind, placebo-controlled trial. Pediatrics, 114(1), e1–e8.PubMedCrossRef
59.
Michelson, D., Fries, D. E., Wernicke, J., Kelsey, D. K., Kendrick, K.L., Sallee, F. R., Spencer, T., Atomoxetine ADHD Study Group. (2001). Atomoxetine in the treatment of children and adolescents with attention deficit/hyperactivity disorder: A randomized, placebo-controlled dose-response study. Pediatrics, 108, e83 http: www.​pediatrics.​org/​cgi/​content/​full/​108/​5/​e83).
60.
Michelson, D., Allen, A. J., Busner, J., Casat, C., Dunn, D., Kratochvil, C., et al. (2002). Once-daily atomoxetine treatment for children and adolescents with attention deficit hyperactivity disorder: A randomized, placebo-controlled study. American Journal of Psychiatry, 159(11), 1896–1901.PubMedCrossRef
61.
Spencer, T., Biederman, J., Wilens, T., Prince, J., Hatch, M., Jones, J., et al. (1998). Effectiveness and tolerability of tomoxetine in adults with attention deficit hyperactivity disorder. American Journal of Psychiatry, 155(5), 693–695.PubMed
62.
Spencer, T., Biederman, J., Heiligenstein, J., Wilens, T. E., Faries, D., Prince, J., et al. (2001). An open-label, dose-ranging study of atomoxetine in children with attention deficit hyperactivity disorder. Journal of Child and Adolescent Psychopharmacology, 11(3), 251–265.PubMedCrossRef
63.
Spencer, T., Heiligenstein, J. H., Biederman, J., Faries, D. E., Kratochvil, C. J., Conners, C. K., et al. (2002). Results from 2 proof-of-concept, placebo-controlled studies of atomoxetine in children with attention-deficit/hyperactivity disorder. Journal of Clinical Psychiatry, 63(12), 1140–1147.PubMedCrossRef
Metagegevens
Titel
Effect of atomoxetine on quality of life and family burden: results from a randomized, placebo-controlled, double-blind study in children and adolescents with ADHD and comorbid oppositional defiant or conduct disorder
Auteurs
Peter M. Wehmeier
Alexander Schacht
Ralf W. Dittmann
Karin Helsberg
Christian Schneider-Fresenius
Martin Lehmann
Monika Bullinger
Ulrike Ravens-Sieberer
Publicatiedatum
01-06-2011
Uitgeverij
Springer Netherlands
Gepubliceerd in
Quality of Life Research / Uitgave 5/2011
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-010-9803-5

Andere artikelen Uitgave 5/2011

The extent to which common health-related quality of life indices capture constructs beyond symptoms and function

Psychometric validation of the S-QoL Chinese (Taiwan) version for patients with schizophrenia

  • Brief Communication

Anhedonia is associated with poor health status and more somatic and cognitive symptoms in patients with coronary artery disease

  • Open Access

Race and gender associations between obesity and nine health-related quality-of-life measures

Measurement properties of the Community Wellbeing Index in older adults

Comparison of 7-day and repeated 24-h recall of type 2 diabetes