Attention Deficit Hyperactivity DisorderPhase 4NCT01339286
Associated Genes With Atomoxetine Response in Attention Deficit Hyperactivity Disorder (ADHD)
A Phase 4 study testing atomoxetine in people with Attention Deficit Hyperactivity Disorder, run by Peking University at 1 site in China.
Trial summary
Attention deficit hyperactivity disorder (ADHD) is the most common behavior disorder, with the prevalence of 3% to 6% in children and adolescents. The patients' academic achievements, professions and social livings are impaired. Comorbid antisocial behavior, substance abuse and delinquency burden family and society. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- atomoxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Mar 2011to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The subject should meet with the DSM-IV ADHD criteria, confirmed by semi-structured interview.
- The subject has not accepted any treatment for ADHD before, or he/she received methylphenidate or atomoxetine treatment but has stopped for 1 or 4 weeks respectively.
- Han Chinese
- Parent sign the informed consent
Who cannot join
- Who are allergy to atomoxetine
- Who can not complete the titration procedure because of untolerable of the side effect
- Who combined other psychotropic drugs or non-drug intervention for ADHD.
- Children who can not be compliant with the blood withdraw.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Sixth Hospital
Beijing, Beijing Municipality, 100191
Li Yang, MD PHD, 86-10-62350880, lyangli375@126.com
About this study
Official title: Study of Associated Gene Polymorphisms With Atomoxetine Response Prediction in ADHD Treatment
Attention deficit hyperactivity disorder (ADHD) is the most common behavior disorder, with the prevalence of 3% to 6% in children and adolescents. The patients' academic achievements, professions and social livings are impaired. Comorbid antisocial behavior, substance abuse and delinquency burden family and society. Stimulants used to be the first line drug. But the medication compliance is poor because of strict drug administration. Atomoxetine is a new non-stimulant drug, which can effectively improve ADHD symptoms. But it achieves effect slowly, the drug responses differ significantly, and side effects interfere compliance. Since genetic factors is the most important cause for different drug responses, this project studies candidate genes potentially associated with atomoxetine medication, with the aim to find 2 to 3 gene polymorphisms influencing the drug response of ADHD. The study adopts cohort design. A sample of more than 100 ADHD cases with atomoxetine medication is to be collected. The rapid genotyping of large sample depends on high-through laboratory. New statistic method is to be used to improve the sensitivity of the target gene detection. There has been no such report in country and overseas. This project will provide basic information for forecasting drug response, improving clinical effects, tolerance and long-term compliance.
- Conditions
- Attention Deficit Hyperactivity Disorder
- 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
Atomoxetine will be titrated to optimal dose, beginning with 0.5mg/kg.d, then increasing to 1.2mg/kg.d in two weeks and maintaining for 4 weeks. If the optimal dose does not achieved, the dose can be increased further to 1.4mg/kg.d and maintained for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| atomoxetine | Experimental | Not described Receives: Drug: atomoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Investigator Rated)
Change from baseline in ADHD Rating Scale: IV (Investigator Rated) after optimal dose treated for 4 weeks
Measured: an expected average of 8 weeks
Secondary outcomes (6)
Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Parent Rated)
Change from baseline in ADHD Rating Scale: IV (Parent Rated) after optimal dose treated for 4 weeks
Measured: an expected average of 8 weeks
Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Teacher Rated)
Change from baseline in ADHD Rating Scale: IV (Teacher Rated) after optimal dose treated for 4 weeks
Measured: An expected average of 8 weeks
Improvement of behaviors as rated by IOWA Conners Rating Scale (Parent Rated)
Change from baseline in IOWA Conners Rating Scale (Parent Rated) after optimal dose treated for 4 weeks
Measured: An expected average of 8 weeks
Improvement of behaviors as rated by IOWA Conners Rating Scale (Teacher Rated)
Change from baseline in IOWA Conners Rating Scale (Teacher Rated) after optimal dose treated for 4 weeks
Measured: An expected average of 8 weeks
Improvement in Clinical Global Impression: Severity
Change from baseline in Clinical Global Impression: Severity after optimal dose treated for 4 weeks
Measured: An expected average of 8 weeks
Side effect
Number of Subjects with Side effects
Measured: An expected average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339286
- Sponsor's protocol ID
- NSFC30800302
- Status last verified
- Apr 2011
- First submitted
- 14 Apr 2011
- Last updated
- 20 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Associated Gene Polymorphisms With Atomoxetine Response Prediction in ADHD Treatment
- ClinicalTrials.gov ID
- NCT01339286
- Acronym / sponsor ID
- NSFC30800302
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (estimated)
- First posted
- 20 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Attention deficit hyperactivity disorder (ADHD) is the most common behavior disorder, with the prevalence of 3% to 6% in children and adolescents. The patients' academic achievements, professions and social livings are impaired. Comorbid antisocial behavior, substance abuse and delinquency burden family and society. Stimulants used to be the first line drug. But the medication compliance is poor because of strict drug administration. Atomoxetine is a new non-stimulant drug, which can effectively improve ADHD symptoms. But it achieves effect slowly, the drug responses differ significantly, and side effects interfere compliance. Since genetic factors is the most important cause for different drug responses, this project studies candidate genes potentially associated with atomoxetine medication, with the aim to find 2 to 3 gene polymorphisms influencing the drug response of ADHD. The study adopts cohort design. A sample of more than 100 ADHD cases with atomoxetine medication is to be collected. The rapid genotyping of large sample depends on high-through laboratory. New statistic method is to be used to improve the sensitivity of the target gene detection. There has been no such report in country and overseas. This project will provide basic information for forecasting drug response, improving clinical effects, tolerance and long-term compliance.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| atomoxetine | Experimental | Drug: atomoxetine |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The subject should meet with the DSM-IV ADHD criteria, confirmed by semi-structured interview.
- The subject has not accepted any treatment for ADHD before, or he/she received methylphenidate or atomoxetine treatment but has stopped for 1 or 4 weeks respectively.
- Han Chinese
- Parent sign the informed consent
Key exclusion criteria (4 listed)
- Who are allergy to atomoxetine
- Who can not complete the titration procedure because of untolerable of the side effect
- Who combined other psychotropic drugs or non-drug intervention for ADHD.
- Children who can not be compliant with the blood withdraw.
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 |
|---|---|---|
| atomoxetineAtomoxetine will be titrated to optimal dose, beginning with 0.5mg/kg.d, then increasing to 1.2mg/kg.d in two weeks and maintaining for 4 weeks. If the optimal dose does not achieved, the dose can be increased further to 1.4mg/kg.d and maintained for 4 weeks. | Drug | atomoxetine |
Primary outcome
Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Investigator Rated)
Time frame: an expected average of 8 weeks
Change from baseline in ADHD Rating Scale: IV (Investigator Rated) after optimal dose treated for 4 weeks
6 secondary outcomes
Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Parent Rated)
Time frame: an expected average of 8 weeks
Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Teacher Rated)
Time frame: An expected average of 8 weeks
Improvement of behaviors as rated by IOWA Conners Rating Scale (Parent Rated)
Time frame: An expected average of 8 weeks
Improvement of behaviors as rated by IOWA Conners Rating Scale (Teacher Rated)
Time frame: An expected average of 8 weeks
Improvement in Clinical Global Impression: Severity
Time frame: An expected average of 8 weeks
Side effect
Time frame: An expected average of 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2011.
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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.
1 site 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, run by Peking University at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 20 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Yang, MD PHD (86-10-62350880, lyangli375@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Investigator Rated) (time frame: an expected average of 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2011.