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Comparison of Atomoxetine Versus Placebo in Children and Adolescents With ADHD and Comorbid ODD in Germany

This study is currently recruiting participants.
Verified by Eli Lilly and Company, September 2008

Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00406354
  Purpose

A three-arm, randomized, double-blind, placebo-controlled Phase 4 multicenter study to compare the efficacy and safety of atomoxetine versus placebo in children and adolescents aged 6 through 17 years with Attention-Deficit/Hyperactivity Disorder (ADHD) and comorbid Oppositional Defiant Disorder (ODD) who are treated as outpatients in Germany. After an initial 3- to 28-day screening and washout phase, patients will be assigned to double-blind treatment with atomoxetine or placebo. A 2 week up-titration period will be succeeded by a 7 week treatment period at the target dose. The primary efficacy measure will be the SNAP-IV ODD subscale score.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Oppositional Defiant Disorder
 Drug: Atomoxetine
Drug: Placebo
 Phase IV

MedlinePlus related topics:   Attention Deficit Hyperactivity Disorder   

ChemIDplus related topics:   Atomoxetine    Atomoxetine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Randomized, Double-Blind Comparison of Atomoxetine Versus Placebo in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder and Comorbid Oppositional Defiant Disorder

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • investigator-rated oppositional subscale of the Swanson, Nolan and Pelham Rating Scale-Revised (SNAP-IV) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SNAP-IV ADHD subscale scores (Inattention subscale score, Hyperactivity/Impulsivity subscale score, and combined score) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Parent Rating Scales for Attention Deficit/Hyperactivity Disorder (FBB-HKS) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Investigator-rated Individual Target Behaviors (ITB-Inv) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impressions-Severity of ADHD(CGI-S-ADHD) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Parent-rated quality of life questionnaire KINDL [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Parent-rated family burden questionnaire FaBel [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Time to treatment discontinuation [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • adverse events (AEs) [ Time Frame: 3 weeks, 9 weeks ] [ Designated as safety issue: No ]
  • Oppositional Defiant/Conduct Disorders (FBB-SSV)of the German Diagnostic System for Mental Disorders in Childhood and Adolescence (DISYPS-KJ) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impressions-Severity of ODD(CGI-S-ODD) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impressions-Severity of ADHD and ODD combined (CGI-S-ADHD+ODD) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:   180
Study Start Date:   November 2006
Estimated Study Completion Date:   February 2009
Estimated Primary Completion Date:   February 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Experimental
0.5 mg/kg/day QD, PO for 1 week then 1.2 mg/kg/day QD, PO for 8 weeks
Drug: Atomoxetine
B: Experimental
0.5 mg/kg/day QD, PO for 1 week then 0.8 mg/kg/day QD, PO for 1 week then 1.2 mg/kg/day QD, PO for 7 weeks
Drug: Atomoxetine
C: Placebo Comparator Drug: Placebo
QD, PO for 9 weeks

  Eligibility
Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Male or female outpatients who are at least 6 years of age, and who will not have reached their 18th birthday
  • Diagnosis of ADHD and ODD
  • Normal intelligence
  • Able to swallow capsules

Exclusion Criteria:

  • Weigh less than 20 kg or more than 90 kg at study entry
  • Prior treatment with atomoxetine
  • History of seizure disorder, suicidal risk, alcohol or drug abuse within the past 3 months
  • History of severe allergies or multiple adverse drug reactions
  • Cardiovascular disorders: hypertension, unexplained cardiac signs or symptoms, QT prolongation, inherited cardiac disorders
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406354

Contacts
Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or     1-317-615-4559    

Locations
Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.     Recruiting
      Achern, Germany, 77855
      Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.     Recruiting
      Bad Kreuznach, Germany, 55543
      Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.     Recruiting
      Berlin, Germany, 13125
      Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.     Recruiting
      Bretten, Germany, 75015
      Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.     Recruiting
      Dillingen, Germany, 66763
      Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.     Recruiting
      Dusseldorf, Germany, 40215
      Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.     Recruiting
      Freiburg, Germany, 79104
      Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.     Recruiting
      Fulda, Germany, 36037
      Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.     Recruiting
      Wurzburg, Germany, 97070
      Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.     Recruiting
      Heppenheim, Germany, 64646
      Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.     Recruiting
      Höchst, Germany, 64739
      Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.     Recruiting
      Köln, Germany, D-50931
      Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.     Recruiting
      Muenchen, Germany, 81241
      Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.     Recruiting
      Munchen, Germany, 80639
      Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.     Recruiting
      Reinheim, Germany, 64351
      Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.     Recruiting
      Waldsassen, Germany, 95652
      Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.     Recruiting
      Hamburg, Germany, 22459
      Contact: Eli Lilly            

Sponsors and Collaborators
Eli Lilly and Company

Investigators
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    
  More Information


Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Eli Lilly ( Chief Medical Officer )
Study ID Numbers:   11149, B4Z-SB-LYDW
First Received:   November 29, 2006
Last Updated:   September 19, 2008
ClinicalTrials.gov Identifier:   NCT00406354
Health Authority:   Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:
Signs and Symptoms
Oppositional defiant disorder
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Atomoxetine
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 20, 2008

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