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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00320528
First received: April 28, 2006
Last updated: December 2, 2009
Last verified: December 2009

April 28, 2006
December 2, 2009
April 2006
October 2008   (final data collection date for primary outcome measure)
Change From Baseline to 12 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE), Achievement Domain [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Achievement of Child Health and Illness Profile–Child Edition (CHIP-CE) of ADHD children and adolescents
  • describe efficacy of atomoxetine given in open-label manner for 12 weeks in improving psychosocial functioning evaluated by mean change of score of domains
Complete list of historical versions of study NCT00320528 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Change From Baseline to 12 Week Endpoint in Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 12 Week Endpoint in CHIP-CE Satisfaction, Comfort, Resilience and Risk Avoidance Domains [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 12 Week Endpoint in Pediatric Anxiety Rating Scale (PARS) [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 12 Week Endpoint in Children's Depression Rating Scale-Revised (CDRS-R) [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 12 Week Endpoint in SNAP-IV Oppositional Scale [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4) [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4) [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 12 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form (CTRS-R:S) [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • 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.
Not Provided
Not Provided
 
Efficacy of Atomoxetine on Psychosocial Function of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
An Open-Label Study of the Efficacy of Atomoxetine Hydrochloride on Quality of Life of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder With or Without Comorbid Conditions

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Attention Deficit Disorder With Hyperactivity
Drug: atomoxetine
0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
Other Names:
  • LY139603
  • Strattera
  • Experimental: Pure ADHD
    Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
    Intervention: Drug: atomoxetine
  • Experimental: ADHD+Internalizing Disorders
    Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
    Intervention: Drug: atomoxetine
  • Experimental: ADHD+Externalizing Disorders
    Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
    Intervention: Drug: atomoxetine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
269
October 2008
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Child or adolescent patients, male or female outpatients, who are at least 6 years of age, but must not yet have reached their 16th birthday prior to Visit 1, when informed consent is obtained
  • Patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnostic criteria for ADHD (any subtype) and score at least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV ADHD Subscale) score at both Visit 1 and 2
  • Laboratory results, including serum chemistries, hematology, and urinalysis, must show no clinically significant abnormalities (clinically significant is defined as laboratory values requiring acute medical intervention, indicating a serious medical illness, or requiring further medical evaluation in the judgment of the investigator)
  • An electrocardiogram (ECG) must be performed to exclude cardiac diseases at the baseline/screening visit and the results must be reviewed by the investigator at Visit 2 prior to dispensing of study material
  • Patients and parents have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including venipuncture, and examinations required by the protocol.

Exclusion Criteria:

  • Patients who have a documented history of Bipolar I or II disorder, any history of psychosis or pervasive development disorder
  • Patients with a history of any seizure disorder (other than febrile seizures) or patients who have taken (or are currently taking) anticonvulsants for seizure control are not eligible to participate
  • Patients at serious suicidal risk as assessed by the investigator
  • Patients with significant cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure
  • Patients who have any medical condition that would increase sympathetic nervous system activity markedly (for example, catecholamine-secreting neural tumor), or who are taking a medication on a daily basis (for example, albuterol, inhalation aerosols, pseudoephedrine), that has sympathomimetic activity. Such medications can be taken on an as-needed basis
Both
6 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00320528
9867, B4Z-IT-LYDS
No
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP