Attention Deficit Hyperactivity DisorderPhase 4NCT00406354
Comparison of Atomoxetine Versus Placebo in Children and Adolescents With ADHD and Comorbid ODD in Germany
A Phase 4 study testing Atomoxetine in people with Attention Deficit Hyperactivity Disorder and Oppositional Defiant Disorder, run by Eli Lilly and Company at 6 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Oppositional Defiant Disorder
- What is being tested?
- Atomoxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 181 participants
- Where
- 6 sitesGermany
- Study dates
- Nov 2006to Jan 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
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.
Berlin, 10789
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.
Düsseldorf, 40215
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.
Fulda, 36037
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.
Hamburg, 22459
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.
Heppenheim an der Bergstrasse, 64646
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.
München, 80639
About this 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
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.
- Being tested
- Atomoxetine, Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Oppositional Defiant Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtomoxetineDrug
Also called LY139603, Strattera
Dosage form for the atomoxetine fast and slow titration arms consists of 2.5 mg, 10 mg, 20 mg, 25 mg, and 40 mg capsules. Double-blind treatment will consist of 3 capsules taken once per day for approximately 9 weeks.
PlaceboDrug
Double-blind treatment will consist of 3 matching placebo capsules taken once per day by mouth for approximately 9 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Atomoxetine Fast Titration | Experimental | 0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks Receives: Drug: Atomoxetine |
| Atomoxetine Slow Titration | Experimental | 0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks Receives: Drug: Atomoxetine |
| Placebo | Placebo comparator | matching placebo daily dose taken orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) Oppositional Defiant Disorder: (ODD) Score
The SNAP-IV, a 26-item scale, includes 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD and 1 item for each of the 8 symptoms contained in the DSM-IV diagnosis of ODD. Each item is scored on a 0 to 3 scale (0=Not at All, 1=Just a Little, 2=Pretty Much, 3=Very Much). The SNAP-IV yields scores in three domains: Inattention (items 1-9: subscore range=0-27), Hyperact-ivity/Impulsivity (items 10-18: subscale range=0-27), and Oppositional (items 19-26: subscale range=0-24). SNAP-IV: ADHD Combined Scale score (inattention + hyperactivity/impulsivity) ranges from 0-54.
Measured: 9 weeks
Secondary outcomes (21)
Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Combined Score
The SNAP-IV: ADHD Combined Subscale for inattention (items 1-9) and hyperactivity/impulsivity (items 11-19) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 54.
Measured: 9 weeks
Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Inattention Score
The SNAP-IV: ADHD Inattention Subscale (items 1-9) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 27.
Measured: 9 weeks
Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): Hyperactivity/Impulsivity Score
The SNAP-IV: ADHD Hyperactivity/Impulsivity Subscale (items 10-18) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 27.
Measured: 9 weeks
Parent-Rated Attention-Deficit Scale (FBB-HKS), Total Score: Severity
FBB-HKS ("Fremdbeurteilungsbogen fur Hyperkinetische Storungen"), the German, parent-rated scale for attention-deficit, is a 20-item rating scale which describes ADHD symptom criteria of DSM-IV and is grouped based upon the 3 ADHD domains: inattention (items 1-9); hyperactivity (items 10-16); impulsivity (items 17-20). Parents rated symptom severity of each item during the last 7 days on a 0 to 3 scale (0=not at all to 3=very much). The total score was calculated for ADHD overall (sum of ratings for items 1-20, divided by 20). Higher scores indicate higher severity of symptoms.
Measured: 9 weeks
Parent-Rated Oppositional Defiant/Conduct Disorders Scale (FBB-SSV): Total Score, Severity
FBB-SSV ("Fremdbeurteilungsbogen fur Storungen des Sozialverhaltens"), the German, parent-rated oppositional defiant/conduct disorders scale, covers 23 criteria for ODD and 25 for conduct disorder (CD) in four sections. Parents rated symptom severity of each item during the last 7 days on a 0 to 3 scale (0=not at all to 3=very much). The total score was calculated for ODD/CD overall (sum of ratings for items 1-17, divided by 17). Higher scores indicate higher severity of symptoms.
Measured: 9 weeks
Investigator-Rated Individual Target Behaviors (ITB-Inv): Intensity Score
ITB-Inv assesses frequency and intensity of individually-defined target behaviors. The investigator defines 3 individual behavior problems based on interviews and additional information. Those most impairing for the child or stressful for the parents will be chosen as target behavior. Intensity during the last 7 days is rated on a 10-point scale (0=no problems to 9=most severe problems) with the lowest possible score of 0 and the highest possible of 27.
Measured: 9 weeks
Investigator-Rated Individual Target Behaviors (ITB-Inv): Frequency Score
ITB-Inv assesses frequency and intensity of individually-defined target behaviors. The investigator defines 3 individual behavior problems based on interviews and additional information. Those most impairing for the child or stressful for the parents will be chosen as target behavior. Frequency of each target behavior during the last 7 days is rated on a 6-point scale (0=never to 5=always) with 0 as lowest possible score and 15 the highest possible score.
Measured: 9 weeks
Impact on Family Scale (FaBel), Total Impact Score
Family burden is assessed by the FaBel questionnaire (German version of the Impact on Family Scale). Questionnaire is answered by participant's caregiver and contains 33 Likert-scaled items to assess general negative impact (of a disability, disorder, disease) on parents, description of social relationships, concern for siblings, financial impact, problems in coping as well as a total score. Each item is rated on a 4-point scale (1=fully applies, 4=applies not at all). Total scores range from 24-96. Higher scores correspond to higher family burden.
Measured: 9 weeks
Clinical Global Impressions - Severity (CGI-S): ADHD Score
The physician-rated CGI-S ADHD measures the participant's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days.
Measured: 9 weeks
Clinical Global Impressions - Severity (CGI-S): ODD Score
The physician-rated CGI-S ODD measures the participant's overall severity of ODD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days.
Measured: 9 weeks
Clinical Global Impressions - Severity (CGI-S): Combined ADHD and ODD Scores
The physician-rated CGI-S Combined ADHD and ODD measures the participant's overall severity of both ADHD and ODD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days.
Measured: 9 weeks
German Revised Children's Quality of Life Questionnaire (KINDL-R): Total Quality of Life Score
KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score in the Total QOL score is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher score indicates better QOL.
Measured: 9 weeks
German Revised Children's Quality of Life Questionnaire (KINDL-R): Physical Well-Being Score
KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Physical Well-Being subscale is 0; highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL.
Measured: 9 weeks
German Revised Children's Quality of Life Questionnaire (KINDL-R): Emotional Well-Being Score
KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time).The lowest possible score for the Emotional Well-Being subscale is 0; highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL.
Measured: 9 weeks
German Revised Children's Quality of Life Questionnaire (KINDL-R): Self Esteem Score
KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Self Esteem subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL.
Measured: 9 weeks
German Revised Children's Quality of Life Questionnaire (KINDL-R): Family Score
KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1=never; 5=all the time). The lowest possible score on the Family subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL.
Measured: 9 weeks
German Revised Children's Quality of Life Questionnaire (KINDL-R): Friends Score
KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Friends subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL.
Measured: 9 weeks
German Revised Children's Quality of Life Questionnaire (KINDL-R): School Score
KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the School subscore is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL.
Measured: 9 weeks
Number of Participants Discontinuing Treatment
Originally, time to treatment discontinuation was analyzed, deeming participants 'censored' if they reached the end of the observation period, were lost to followup, or withdrew informed consent. Because the median was not reached, the number of participants who discontinued (i.e., those who were not censored) is reported here.
Measured: 9 weeks
Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Initial Three Weeks of Study Treatment
Number of participants who experienced pre-specified categories of clinically relevant adverse events during the initial three-weeks of study treatment. NOTE: this is a subset of the overall adverse events which are reported by participant and event.
Measured: 3 weeks
Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Nine-Week Study Treatment Period
Number of participants who experienced pre-specified categories of clinically relevant adverse events during the nine-week study treatment period. NOTE: this is a subset of the overall adverse events which are reported by participant and event.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startNov 2006
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00406354
- Sponsor's protocol ID
- 11149
- Other IDs
- B4Z-SB-LYDW
- Status last verified
- Feb 2010
- First submitted
- 29 Nov 2006
- Last updated
- 26 Feb 2010
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 25019647
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00406354
- Acronym / sponsor ID
- 11149
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 4 Dec 2006 (estimated)
- Results
- Posted 12 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atomoxetine Fast Titration | Experimental | Drug: Atomoxetine0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks |
| Atomoxetine Slow Titration | Experimental | Drug: Atomoxetine0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks |
| Placebo | Placebo comparator | Drug: Placebomatching placebo daily dose taken orally |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtomoxetineAlso: LY139603, StratteraDosage form for the atomoxetine fast and slow titration arms consists of 2.5 mg, 10 mg, 20 mg, 25 mg, and 40 mg capsules. Double-blind treatment will consist of 3 capsules taken once per day for approximately 9 weeks. | Drug | Atomoxetine Fast Titration, Atomoxetine Slow Titration |
| PlaceboDouble-blind treatment will consist of 3 matching placebo capsules taken once per day by mouth for approximately 9 weeks. | Drug | Placebo |
Primary outcome
Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) Oppositional Defiant Disorder: (ODD) Score
Time frame: 9 weeks
The SNAP-IV, a 26-item scale, includes 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD and 1 item for each of the 8 symptoms contained in the DSM-IV diagnosis of ODD. Each item is scored on a 0 to 3 scale (0=Not at All, 1=Just a Little, 2=Pretty Much, 3=Very Much). The SNAP-IV yields scores in three domains: Inattention (items 1-9: subscore range=0-27), Hyperact-ivity/Impulsivity (items 10-18: subscale range=0-27), and Oppositional (items 19-26: subscale range=0-24). SNAP-IV: ADHD Combined Scale score (inattention + hyperactivity/impulsivity) ranges from 0-54.
21 secondary outcomes
Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Combined Score
Time frame: 9 weeks
Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Inattention Score
Time frame: 9 weeks
Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): Hyperactivity/Impulsivity Score
Time frame: 9 weeks
Parent-Rated Attention-Deficit Scale (FBB-HKS), Total Score: Severity
Time frame: 9 weeks
Parent-Rated Oppositional Defiant/Conduct Disorders Scale (FBB-SSV): Total Score, Severity
Time frame: 9 weeks
Investigator-Rated Individual Target Behaviors (ITB-Inv): Intensity Score
Time frame: 9 weeks
Investigator-Rated Individual Target Behaviors (ITB-Inv): Frequency Score
Time frame: 9 weeks
Impact on Family Scale (FaBel), Total Impact Score
Time frame: 9 weeks
Clinical Global Impressions - Severity (CGI-S): ADHD Score
Time frame: 9 weeks
Clinical Global Impressions - Severity (CGI-S): ODD Score
Time frame: 9 weeks
Clinical Global Impressions - Severity (CGI-S): Combined ADHD and ODD Scores
Time frame: 9 weeks
German Revised Children's Quality of Life Questionnaire (KINDL-R): Total Quality of Life Score
Time frame: 9 weeks
German Revised Children's Quality of Life Questionnaire (KINDL-R): Physical Well-Being Score
Time frame: 9 weeks
German Revised Children's Quality of Life Questionnaire (KINDL-R): Emotional Well-Being Score
Time frame: 9 weeks
German Revised Children's Quality of Life Questionnaire (KINDL-R): Self Esteem Score
Time frame: 9 weeks
German Revised Children's Quality of Life Questionnaire (KINDL-R): Family Score
Time frame: 9 weeks
German Revised Children's Quality of Life Questionnaire (KINDL-R): Friends Score
Time frame: 9 weeks
German Revised Children's Quality of Life Questionnaire (KINDL-R): School Score
Time frame: 9 weeks
Number of Participants Discontinuing Treatment
Time frame: 9 weeks
Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Initial Three Weeks of Study Treatment
Time frame: 3 weeks
Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Nine-Week Study Treatment Period
Time frame: 9 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25019647Bangs 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.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
Related trials for Attention Deficit Hyperactivity Disorder
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atomoxetine in people with Attention Deficit Hyperactivity Disorder and Oppositional Defiant Disorder, run by Eli Lilly and Company at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) Oppositional Defiant Disorder: (ODD) Score (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00406354, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2010.