Clinical trial NCT00406354: Comparison of Atomoxetine Versus Placebo in Children and Adolescents With ADHD and Comorbid ODD in Germany
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Oppositional Defiant Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-12-04
Enrollment: 181
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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, participants 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 Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) ODD subscale score.


Eligibility 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 presence of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria A through C for ODD (NOTE: diagnosis for conduct disorder not exclusionary)
* Normal intelligence
* Able to swallow capsules

Exclusion Criteria:

* Weigh less than 20 kilogram (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 (measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle) prolongation , inherited cardiac disorders

Primary outcomes:
measure: Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) Oppositional Defiant Disorder: (ODD) Score
timeFrame: 9 weeks
Secondary outcomes:
measure: Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Combined Score
timeFrame: 9 weeks
measure: Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Inattention Score
timeFrame: 9 weeks
measure: Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): Hyperactivity/Impulsivity Score
timeFrame: 9 weeks
measure: Parent-Rated Attention-Deficit Scale (FBB-HKS), Total Score: Severity
timeFrame: 9 weeks
measure: Parent-Rated Oppositional Defiant/Conduct Disorders Scale (FBB-SSV): Total Score, Severity
timeFrame: 9 weeks
measure: Investigator-Rated Individual Target Behaviors (ITB-Inv): Intensity Score
timeFrame: 9 weeks
measure: Investigator-Rated Individual Target Behaviors (ITB-Inv): Frequency Score
timeFrame: 9 weeks
measure: Impact on Family Scale (FaBel), Total Impact Score
timeFrame: 9 weeks
measure: Clinical Global Impressions - Severity (CGI-S): ADHD Score
timeFrame: 9 weeks
measure: Clinical Global Impressions - Severity (CGI-S): ODD Score
timeFrame: 9 weeks
measure: Clinical Global Impressions - Severity (CGI-S): Combined ADHD and ODD Scores
timeFrame: 9 weeks
measure: German Revised Children's Quality of Life Questionnaire (KINDL-R): Total Quality of Life Score
timeFrame: 9 weeks
measure: German Revised Children's Quality of Life Questionnaire (KINDL-R): Physical Well-Being Score
timeFrame: 9 weeks
measure: German Revised Children's Quality of Life Questionnaire (KINDL-R): Emotional Well-Being Score
timeFrame: 9 weeks
measure: German Revised Children's Quality of Life Questionnaire (KINDL-R): Self Esteem Score
timeFrame: 9 weeks
measure: German Revised Children's Quality of Life Questionnaire (KINDL-R): Family Score
timeFrame: 9 weeks
measure: German Revised Children's Quality of Life Questionnaire (KINDL-R): Friends Score
timeFrame: 9 weeks
measure: German Revised Children's Quality of Life Questionnaire (KINDL-R): School Score
timeFrame: 9 weeks
measure: Number of Participants Discontinuing Treatment
timeFrame: 9 weeks
measure: Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Initial Three Weeks of Study Treatment
timeFrame: 3 weeks
measure: Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Nine-Week Study Treatment Period
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: 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.
city: Dusseldorf
country: Germany
facility: 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.
city: Fulda
country: Germany
facility: 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.
city: Hamburg
country: Germany
facility: 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.
city: Heppenheim
country: Germany
facility: 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.
city: Munchen
country: Germany
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: Bangs ME, Wietecha LA, Wang S, Buchanan AS, Kelsey DK. Meta-analysis of suicide-related behavior or ideation in child, adolescent, and adult patients treated with atomoxetine. J Child Adolesc Psychopharmacol. 2014 Oct;24(8):426-34. doi: 10.1089/cap.2014.0005. Epub 2014 Jul 14.