Efficacy and Safety of Atomoxetine in Children With Recent Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191945
First received: September 12, 2005
Last updated: January 26, 2010
Last verified: January 2010

September 12, 2005
January 26, 2010
May 2005
February 2008   (final data collection date for primary outcome measure)
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 12 Week Endpoint [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
ADHDRS-IV-Parent:Inv total score.
Complete list of historical versions of study NCT00191945 on ClinicalTrials.gov Archive Site
  • Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 9 Weeks [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
  • Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 6 Weeks [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 4 Weeks [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score Change From Week 6 to Week 12 [ Time Frame: week 6 and week 12 ] [ Designated as safety issue: No ]
  • Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Changes From Baseline to Visit 7 (12 Weeks) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Change From Baseline to Endpoint (Visit 18) of the Open-Label Extension (107 Weeks) [ Time Frame: Baseline and Open-Label Endpoint (107 weeks) ] [ Designated as safety issue: No ]
  • Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Total Score Changes From Baseline to Endpoint (Week 12) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks) [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
  • Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) at 107 Weeks (Open-Label Extension) [ Time Frame: Week 107 ] [ Designated as safety issue: No ]
  • Vital Signs - Systolic Blood Pressure [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: Yes ]
  • Vital Signs - Diastolic Blood Pressure [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: Yes ]
  • Vital Signs - Pulse [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: Yes ]
  • Vital Signs - Weight [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: Yes ]
  • - Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity
  • - Conners' Parent Rating Scale-Revised: Short Form.
Not Provided
Not Provided
 
Efficacy and Safety of Atomoxetine in Children With Recent Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)
A Randomized Double-Blind, Placebo-Controlled Clinical Trial of Efficacy and Safety of Atomoxetine up to 12 Weeks in Newly Diagnosed Children and Adolescents Outpatients With Attention-Deficit/Hyperactivity Disorder

Double blinded clinical trial placebo controlled in 153 children (planned enrollment) with recent diagnosis of ADHD. Patients will be randomized to atomoxetine or placebo arm (2:1). The double blinded period will last 12 weeks and the treatment open phase will last up to 1 year, and atomoxetine treatment will be administered.

A gatekeeper strategy will be employed for sequentially testing the secondary objectives.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
  • Drug: Atomoxetine Hydrochloride
    Other Names:
    • LY139603
    • Strattera
  • Drug: placebo
  • Experimental: Atomoxetine
    atomoxetine: 0.5 mg/kg/day every day (QD),by mouth (PO) for 2 weeks, 1.2 - 1.4 mg/kg/day QD, PO for 10 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1 year
    Intervention: Drug: Atomoxetine Hydrochloride
  • Placebo Comparator: Placebo
    placebo every day (QD), by mouth (PO) for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1 year (open-label extension)
    Interventions:
    • Drug: Atomoxetine Hydrochloride
    • Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
151
February 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Child or adolescent patients must be at least 6 years of age, but must not yet have reached their 16th birthday prior to Visit 1, when informed consent is obtained.
  2. Patients must meet the Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition Text Revision (DSM-IV-TR) diagnostic criteria for ADHD. For the purposes of this study the diagnosis of ADHD will be confirmed during Visit 1 by administering the K-SADS-PL. Patients must also have an ADHDRS-IV-Parent:Inv score at least 1.5 standard deviations above the age norm for their diagnostic subtype at both Visit 1 and Visit 2. In addition, they must have a CGI-ADHD-S score 4 at both Visit 1 and Visit 2.
  3. Patients must have a newly diagnosed case of ADHD. Newly diagnosed case of ADHD means that a specialist (including pediatrician, child psychiatrist, or child neurologist) or child psychologist has diagnosed ADHD (according DSM-IV-TR or International Statistical Classification of Diseases and Related Health Problems [World Health Organisation; 10th Revision] [ICD 10] criteria) within 3 months prior to Visit 1.

Exclusion Criteria:

  1. Patients with history of ADHD diagnosis longer than 3 months prior to Visit 1. Diagnosis of ADHD means that a specialist (including pediatrician, child psychiatrist, or child neurologist) or child psychologist has diagnosed ADHD (according DSM-IV-TR or ICD 10 criteria) and has registered it in medical records or verbally informed parents about this diagnosis.
  2. Patients who weigh less than 20 kg at study entry (Visit 1). If a patient's weight changes after Visit 1 to a value outside of the stated range, the patient will still be eligible, and the weight should be rounded to the nearest value within the above range for dosing purposes.
Both
6 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00191945
8836, B4Z-XM-LYDM
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 to 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
January 2010

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