Clinical Trial: Efficacy of Atomoxetine on Psychosocial Function of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open-Label Study of the Efficacy of Atomoxetine Hydrochloride on Quality of Life of Children and Adolescents With Attention-Deficit/Hyperactivity

Brief Summary: This study aims to assess the effectiveness of atomoxetine on psychosocial functioning and emotional well being of children and adolescents with ADHD and to evaluate whether and in what measure the presence of comorbid conditions (internalizing and externalizing disorders) influences atomoxetine's ability to improve the quality of life of ADHD subjects.

Detailed Summary:
Sponsor: Eli Lilly and Company

Current Primary Outcome: Change From Baseline to 12 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE), Achievement Domain [ Time Frame: Baseline, 12 Weeks ]

Original Primary Outcome:

  • describe efficacy of atomoxetine given in open-label manner for 12 weeks in improving psychosocial functioning evaluated by mean change of score of domains
  • Achievement of Child Health and Illness Profile-Child Edition (CHIP-CE) of ADHD children and adolescents


Current Secondary Outcome:

  • Change From Baseline to 12 Week Endpoint in the Attention-Deficit/Hyperactivity Disorder (ADHD) Subscales of 18-Item Swanson, Nolan and Pelham Rating Scale (SNAP-IV) [ Time Frame: Baseline, 12 Weeks ]
  • Change From Baseline to 12 Week Endpoint in Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) [ Time Frame: Baseline, 12 Weeks ]
  • Change From Baseline to 12 Week Endpoint in CHIP-CE Satisfaction, Comfort, Resilience and Risk Avoidance Domains [ Time Frame: Baseline, 12 Weeks ]
  • Change From Baseline to 12 Week Endpoint in Pediatric Anxiety Rating Scale (PARS) [ Time Frame: Baseline, 12 Weeks ]
  • Change From Baseline to 12 Week Endpoint in Children's Depression Rating Scale-Revised (CDRS-R) [ Time Frame: Baseline, 12 Weeks ]
  • Change From Baseline to 12 Week Endpoint in SNAP-IV Oppositional Scale [ Time Frame: Baseline, 12 Weeks ]
  • Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4) [ Time Frame: Baseline, 12 Weeks ]
  • Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4) [ Time Frame: Baseline, 12 Weeks ]
  • Change From Baseline to 12 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form (CTRS-R:S) [ Time Frame: Baseline, 12 Weeks ]


Original Secondary Outcome:

  • To assess whether the effect of atomoxetine in improving ADHD core symptoms is influenced by the presence of comorbid conditions,
  • using the mean change on the 18 items of the ADHD subscale SNAP-IV and the Clinical Global Impressions-ADHD-Severity
  • To assess whether atomoxetine has a different impact on the various aspects of life evaluated by the score of the other domains of the CHIP-CE.
  • To investigate the effect of atomoxetine on internalizing and externalizing comorbid disorders as measured by the investigator-rated scales for anxiety and mood disorders.
  • To evaluate ADHD symptoms change and comorbidity symptoms change assessed by parents and teachers.


Information By: Eli Lilly and Company

Dates:
Date Received: April 28, 2006
Date Started: April 2006
Date Completion:
Last Updated: December 2, 2009
Last Verified: December 2009