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Attention Deficit Hyperactivity DisorderPhase 4NCT00471354

A Study for Patients With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine

A Phase 4 study testing Atomoxetine in people with Attention Deficit Hyperactivity Disorder, run by Eli Lilly and Company at 8 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to investigate the relationship of changes in measures of academic performance and problem behaviors, to changes in core Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in Asian children treated with atomoxetine. Read more about this study

Who is it for?
Ages 8 to 11 years
Conditions the study is for
Attention Deficit Hyperactivity Disorder
What is being tested?
Atomoxetine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
228 participants
Where
8 sitesin 3 countries
Study dates
Apr 2007to Nov 2008
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 8 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Male or female outpatients between 8 and 11 years of age at study entry
  • Attention-Deficit/Hyperactivity Disorder (ADHD) meeting the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) disease diagnostic criteria
  • Patients who have never received medications psychotropic medications specifically to treat ADHD, or if they have received medication, that the trial of the psychotropic medication(s) was of less than 1 month duration, and occurred more than 6 months prior to study entry
  • Normal intelligence in the judgment of the investigator
  • Must be able to swallow capsules

Who cannot join

  • Current or past history of bipolar I or II disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, or conduct disorder
  • History of seizure disorder or currently taking anticonvulsants for seizure control
  • Serious suicidal risk as determined by investigator
  • Cardiovascular disease; current or past history of hypertension
  • Previous treatment with atomoxetine

Trial locations and contacts

8 sites in 3 countries.

8 sites in 3 countries

Taiwan4 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 ph

    Neihu Taipei, 114

  • 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 ph

    Niao Sung Hsiang, 833

  • 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 ph

    Taipei, 100

  • 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 ph

    Taoyuan, 333

Other trials in Taiwan

China2 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 ph

    Beijing, 100088

  • 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 ph

    Shanghai, 200127

Other trials in China

South Korea2 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 ph

    Pusan, 609-739

  • 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 ph

    Seoul, 138-736

Other trials in South Korea

About this study

Official title: Evaluation of Academic Performance in Asian Children Aged 8 to 11 Years With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine Hydrochloride

The purpose of the study is to investigate the relationship of changes in measures of academic performance and problem behaviors, to changes in core Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in Asian children treated with atomoxetine.

Being tested
Atomoxetine
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtomoxetineDrug

    Also called LY139603, Strattera

    atomoxetine 0.5 mg/kg/day once a day (QD), by mouth (PO) starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.

Study groups in NCT00471354
Study groupRoleWhat they receive
AtomoxetineExperimental0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
Receives: Drug: Atomoxetine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation Between Change From Baseline and 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent:Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and School Grade Average (SGA)

    Correlation was calculated between change from baseline and endpoint in ADHD-RS Total Score and change in SGA total score. ADHD-RS measures 18 symptoms associated with diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. SGA: Grades (0 to 100) in classes of Language, Math, and Science were obtained and average taken to get SGA Total Score between 0 and 100; higher scores indicating better grades/apptitude. Any ordinal grades were imputed to numerical grades based on communication with relevant schools.

    Measured: Baseline, 24 weeks

Secondary outcomes (6)

  1. Correlation Between Change From Baseline to 24 Week Endpoint in ADHDRS-IV-Parent:Inv Total Score and School Grade Averages in Separate Language, Math and Science Classes

    Correlation was calculated between change from baseline and endpoint in ADHD-RS Total Score and change in separate SGA language, math, and science scores. ADHD-RS measures 18 symptoms associated with diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. SGA: separate language, math, and science school grades on a scale of 0-100, with higher scores indicating better grades/apptitude in the respective class. Any ordinal grades were imputed to numerical grades based on communication with relevant schools.

    Measured: Baseline, 24 weeks

  2. Change From Baseline to 24 Week Endpoint in Academic Performance by School Grade Average (SGA) Total, and Separate Language, Math, and Science Scores

    Separate school grades in the classes of Language, Math, and Science were obtained. A score between 0 and 100 was provided for each of the three classes, and the average taken to get a SGA Total Score between 0 and 100, with higher scores indicating better grades/apptitude in each class and overall. Any ordinal grades were imputed to numerical grades based on communication with relevant schools.

    Measured: Baseline, 24 weeks

  3. Change From Baseline to 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored - Total Score

    Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.

    Measured: Baseline, 24 weeks

  4. Change From Baseline to 24 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder - Severity Scale (CGI-ADHD-S)

    Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).

    Measured: Baseline, 24 weeks

  5. CGI-ADHD-Improvement Scale (CGI-ADHD-I) at 24 Week Endpoint

    Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened).

    Measured: 24 weeks

  6. Change From Baseline to 24 Week Endpoint in Revised Conners' Parent Rating Scale: Short Form (CPRS-R:S) Attention-Deficit/Hyperactivity Disorder Index Score

    A 27-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the parent to assess problem behaviors related to ADHD. Subscale assessed: ADHD Index. ADHD Index is the sum of items 1, 5, 7, 10, 13, 15, 17, 19, 21, 23, 25, and 27. Subscale total scores range from 0 to 36. Higher scores reflect more severe problem behaviors related to ADHD.

    Measured: Baseline, 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2007 (estimated)
  2. Study startApr 2007
  3. Primary completionNov 2008
  4. Study completionNov 2008

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00471354
Sponsor's protocol ID
11098
Other IDs
B4Z-CR-S018
Status last verified
Jan 2010
First submitted
7 May 2007
Last updated
12 Jan 2010
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Atomoxetine in people with Attention Deficit Hyperactivity Disorder, run by Eli Lilly and Company at 8 sites in 3 countries.

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 5 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 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Taiwan, China, South Korea. 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. 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 31 Dec 2009). 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?

Correlation Between Change From Baseline and 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent:Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and School Grade Average (SGA) (time frame: Baseline, 24 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 NCT00471354.

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 12 Jan 2010.

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