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Atomoxetine treatment and ADHD-related difficulties as assessed by adolescent patients, their parents and physicians.

Dittmann RW, Wehmeier PM, Schacht A, Minarzyk A, Lehmann M, Sevecke K, Lehmkuhl G - Child Adolesc Psychiatry Ment Health (2009)

Bottom Line: For all raters, GIPD scores significantly improved over time.ADHD-RS and CGI-S scores significantly improved over the course of the study (based on 95% CIs).Tolerability results were consistent with earlier reports.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Child and Adolescent Psychiatry, Central Institute of Mental Health Mannheim, University of Heidelberg, Germany. ralf.dittmann@zi-mannheim.de

ABSTRACT

Background: The degree of ADHD-related difficulties - reflecting overall impairment, social functioning, and quality of life - may be perceived differently by adolescent patients, parents and physicians. The primary aim of this study was to investigate ADHD-related difficulties during atomoxetine treatment, as perceived by the three different raters. Secondary objectives focused on effectiveness and tolerability of atomoxetine treatment in a population of adolescent patients with ADHD.

Methods: Adolescents with ADHD, aged 12-17 years, received open-label atomoxetine (0.5-1.2 mg/kg/day) up to 24 weeks. ADHD-related difficulties at various times of the day were rated using the Global Impression of Perceived Difficulties (GIPD) instrument. Inter-rater agreement was analyzed using Cohen's Kappa with 95% confidence intervals (95% CI). ADHD-Rating Scale (ADHD-RS) and Clinical Global Impression Severity (GGI-S) scores were assessed by the investigator; and spontaneous adverse events, vital signs and laboratory parameters were collected for tolerability assessments.

Results: 159 patients received atomoxetine. Patients' baseline mean GIPD total ratings were significantly lower than parents' and physicians' scores (12.5 [95%CI 11.6;13.5] vs. 17.2 [16.2;18.2] and 18.8 [17.8;19.8]). For all raters, GIPD scores significantly improved over time. Changes were greatest within the first two weeks. Kappa coefficients varied between 0.186 [0.112;0.259] and 0.662 [0.529;0.795], with strongest agreements between parent and physician assessments, and significant improvements of patient/physician agreements over time (based on 95% CIs). ADHD-RS and CGI-S scores significantly improved over the course of the study (based on 95% CIs). Tolerability results were consistent with earlier reports.

Conclusion: ADHD-related difficulties were perceived differently by the raters in this open-label trial, but consistently improved during atomoxetine treatment. The GIPD instrument appeared sensitive to treatment-related change. These primarily quantitative findings may guide future studies to more systematically investigate the clinical and practical relevance of the differences observed. Additionally, in order to further validate these results, placebo- and comparator-controlled trials are recommended as well as inclusion of healthy controls and other patient populations.

Clinical trial registry: ClinicalTrials.gov: NCT00191737.

No MeSH data available.


Related in: MedlinePlus

Patient disposition.
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Figure 1: Patient disposition.

Mentions: Of the 160 patients screened, 159 patients (100%) were enrolled in the study and treated with atomoxetine, 137 (86.2%) patients completed the treatment period and continued into the extension period. 20 (12.6%) patients discontinued early over the course of the 8 week treatment period, two more (1.3%) completed the treatment period, but did not continue into the extension period based on the decision of the physician. 26 (16.4%) patients discontinued between weeks 8 and 24. 111 (69.8%) patients completed the study at week 24. Discontinuations were mostly due to lack of efficacy. All reasons for discontinuation are shown in Figure 1.


Atomoxetine treatment and ADHD-related difficulties as assessed by adolescent patients, their parents and physicians.

Dittmann RW, Wehmeier PM, Schacht A, Minarzyk A, Lehmann M, Sevecke K, Lehmkuhl G - Child Adolesc Psychiatry Ment Health (2009)

Patient disposition.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2746185&req=5

Figure 1: Patient disposition.
Mentions: Of the 160 patients screened, 159 patients (100%) were enrolled in the study and treated with atomoxetine, 137 (86.2%) patients completed the treatment period and continued into the extension period. 20 (12.6%) patients discontinued early over the course of the 8 week treatment period, two more (1.3%) completed the treatment period, but did not continue into the extension period based on the decision of the physician. 26 (16.4%) patients discontinued between weeks 8 and 24. 111 (69.8%) patients completed the study at week 24. Discontinuations were mostly due to lack of efficacy. All reasons for discontinuation are shown in Figure 1.

Bottom Line: For all raters, GIPD scores significantly improved over time.ADHD-RS and CGI-S scores significantly improved over the course of the study (based on 95% CIs).Tolerability results were consistent with earlier reports.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Child and Adolescent Psychiatry, Central Institute of Mental Health Mannheim, University of Heidelberg, Germany. ralf.dittmann@zi-mannheim.de

ABSTRACT

Background: The degree of ADHD-related difficulties - reflecting overall impairment, social functioning, and quality of life - may be perceived differently by adolescent patients, parents and physicians. The primary aim of this study was to investigate ADHD-related difficulties during atomoxetine treatment, as perceived by the three different raters. Secondary objectives focused on effectiveness and tolerability of atomoxetine treatment in a population of adolescent patients with ADHD.

Methods: Adolescents with ADHD, aged 12-17 years, received open-label atomoxetine (0.5-1.2 mg/kg/day) up to 24 weeks. ADHD-related difficulties at various times of the day were rated using the Global Impression of Perceived Difficulties (GIPD) instrument. Inter-rater agreement was analyzed using Cohen's Kappa with 95% confidence intervals (95% CI). ADHD-Rating Scale (ADHD-RS) and Clinical Global Impression Severity (GGI-S) scores were assessed by the investigator; and spontaneous adverse events, vital signs and laboratory parameters were collected for tolerability assessments.

Results: 159 patients received atomoxetine. Patients' baseline mean GIPD total ratings were significantly lower than parents' and physicians' scores (12.5 [95%CI 11.6;13.5] vs. 17.2 [16.2;18.2] and 18.8 [17.8;19.8]). For all raters, GIPD scores significantly improved over time. Changes were greatest within the first two weeks. Kappa coefficients varied between 0.186 [0.112;0.259] and 0.662 [0.529;0.795], with strongest agreements between parent and physician assessments, and significant improvements of patient/physician agreements over time (based on 95% CIs). ADHD-RS and CGI-S scores significantly improved over the course of the study (based on 95% CIs). Tolerability results were consistent with earlier reports.

Conclusion: ADHD-related difficulties were perceived differently by the raters in this open-label trial, but consistently improved during atomoxetine treatment. The GIPD instrument appeared sensitive to treatment-related change. These primarily quantitative findings may guide future studies to more systematically investigate the clinical and practical relevance of the differences observed. Additionally, in order to further validate these results, placebo- and comparator-controlled trials are recommended as well as inclusion of healthy controls and other patient populations.

Clinical trial registry: ClinicalTrials.gov: NCT00191737.

No MeSH data available.


Related in: MedlinePlus