ADHDPhase 4CAIACNCT03661788
Network Connectivity and Inhibitory Control Under Atomoxetin Challenge- A Pharmacological 'Resting State' and 'Inhibiton Task' Study in Patients With ADHD
A Phase 4 study testing Atomoxetine in people with ADHD, run by RWTH Aachen University at 1 site in Germany.
Trial summary
Attention deficit /hyperactivity disorder (ADHD) is a disorder which manifests in childhood but often persists through adulthood. The most prominent symptoms in adults are inattention, emotional instability, disorganized behavior, impulsivity and restlessness, which cause several restrictions in different areas of… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- ADHD
- 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
- 38 participants
- Where
- 1 siteGermany
- Study dates
- May 2016to 27 Jun 2018
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Male Age 18-45 years Diagnosis of ADHD (patients) or no axis I disorder (controls) according the DSM IV No substance abuse/ dependency Understanding of the study information and declaration of agreement Ability to read, understand and speak German No severe medical disorders No risk for suicide
Who cannot join
- Drug dependence or the a positive drug screening Other Severe physical disorders Current pharmacological therapy because of another psychiatric disorder Risk for seizure or cardiac problems Impaired liver and renal function Significant deviations in regard to clinical chemistry, haematology or EKG Relationship of dependency with the sponsor or the investigator Unable to keep to the study protocol Known Intolerance of the study medication fMRI scanner incompatibility
Trial locations and contacts
1 site in 1 country.
About this study
Attention deficit /hyperactivity disorder (ADHD) is a disorder which manifests in childhood but often persists through adulthood. The most prominent symptoms in adults are inattention, emotional instability, disorganized behavior, impulsivity and restlessness, which cause several restrictions in different areas of life. It is suggested that those symptoms can be attributed to a general deficit in inhibitory control. This hypothesis is supported by several studies revealing that patients with ADHD show poor performance completing inhibitory control tasks.
Furthermore, studies showed that a unique administration of atomoxetin (ATX) significantly improves inhibitory control in patients with ADHD as well as in healthy participtants. In contrast to other medication authorized for the treatment of patients with ADHD, does ATX has no risk for potential addiction. Due its indirect mode of action, ATX has a delayed effect occurence taking up to 2 weeks. However, this apects was unconsidered in those studies.
Read more
Although we directly often associate failures in cognitive control with disruptions at prefrontal areas of the brain, there exists a specific brain network which is called the default mode network (DMN), which is suggested to be at least partly responsibe for the ADHD symptomatic.
The following study is interested in which way a 2- week intake of ATX affects the DMN and surrounding networks in their connectivity during a inhibitory control task and during rest in patients with ADHD vs controls.
- Conditions
- ADHD
- Being tested
- Atomoxetine, Placebos
- Keywords
- Atomoxetin, fMRT
- 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 Strattera
14-day treatment interval: first week 40 mg atomoxetine (one pill), second week 80mg atomoxetine (two pills)
PlacebosDrug
14-day treatment interval: first week one placebo pill, second week two placebo pills
| Study group | Role | What they receive |
|---|---|---|
| First placebo, than atomoxetin | Experimental | Patients receive a placebo in the first of the two 14-day treatment intervals and atomoxetin in the second 14-day treatment intervals. Between the treatment intervals there is a wash-out phase of two weeks. The order of treatment is randomized. Receives: Drug: Atomoxetine; Drug: Placebos |
| First atomoxetin, than placebo | Experimental | Patients receive atomoxetin in the first of the two 14-day treatment intervals and a placebo in the second 14-day treatment interval. Between the treatment intervals there is a wash-out phase of two weeks. The order of treatment is randomized. Receives: Drug: Atomoxetine; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
FMRT resting state connecitivty of the default mode network
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study startMay 2016
- Primary completion6 Dec 2017
- Study completion27 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661788
- Sponsor's protocol ID
- 11-185 CAIAC
- Other IDs
- 2013-002386-18
- Acronym
- CAIAC
- Status last verified
- Sep 2018
- First submitted
- 4 Sep 2018
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data will be uploaded into the data pool of the Deutsches Netzwerk zu psychischen Erkrankungen.
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Network Connectivity and Inhibitory Control Under Atomoxetin Challenge- A Pharmacological 'Resting State' and 'Inhibiton Task' Study in Patients With ADHD
- ClinicalTrials.gov ID
- NCT03661788
- Acronym / sponsor ID
- CAIAC / 11-185 CAIAC
- Conditions
- ADHD
- Keywords
- Atomoxetin, fMRT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 6 Dec 2017 (actual)
- Study completion
- 27 Jun 2018 (actual)
- First posted
- 7 Sep 2018 (actual)
- 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 a disorder which manifests in childhood but often persists through adulthood. The most prominent symptoms in adults are inattention, emotional instability, disorganized behavior, impulsivity and restlessness, which cause several restrictions in different areas of life. It is suggested that those symptoms can be attributed to a general deficit in inhibitory control. This hypothesis is supported by several studies revealing that patients with ADHD show poor performance completing inhibitory control tasks.
Furthermore, studies showed that a unique administration of atomoxetin (ATX) significantly improves inhibitory control in patients with ADHD as well as in healthy participtants. In contrast to other medication authorized for the treatment of patients with ADHD, does ATX has no risk for potential addiction. Due its indirect mode of action, ATX has a delayed effect occurence taking up to 2 weeks. However, this apects was unconsidered in those studies.
Although we directly often associate failures in cognitive control with disruptions at prefrontal areas of the brain, there exists a specific brain network which is called the default mode network (DMN), which is suggested to be at least partly responsibe for the ADHD symptomatic.
The following study is interested in which way a 2- week intake of ATX affects the DMN and surrounding networks in their connectivity during a inhibitory control task and during rest in patients with ADHD vs controls.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First placebo, than atomoxetin | Experimental | Drug: Atomoxetine, Drug: PlacebosPatients receive a placebo in the first of the two 14-day treatment intervals and atomoxetin in the second 14-day treatment intervals. Between the treatment intervals there is a wash-out phase of two weeks. The order of treatment is randomized. |
| First atomoxetin, than placebo | Experimental | Drug: Atomoxetine, Drug: PlacebosPatients receive atomoxetin in the first of the two 14-day treatment intervals and a placebo in the second 14-day treatment interval. Between the treatment intervals there is a wash-out phase of two weeks. The order of treatment is randomized. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male Age 18-45 years Diagnosis of ADHD (patients) or no axis I disorder (controls) according the DSM IV No substance abuse/ dependency Understanding of the study information and declaration of agreement Ability to read, understand and speak German No severe medical disorders No risk for suicide
Key exclusion criteria (1 listed)
- Drug dependence or the a positive drug screening Other Severe physical disorders Current pharmacological therapy because of another psychiatric disorder Risk for seizure or cardiac problems Impaired liver and renal function Significant deviations in regard to clinical chemistry, haematology or EKG Relationship of dependency with the sponsor or the investigator Unable to keep to the study protocol Known Intolerance of the study medication fMRI scanner incompatibility
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: Strattera14-day treatment interval: first week 40 mg atomoxetine (one pill), second week 80mg atomoxetine (two pills) | Drug | First atomoxetin, than placebo, First placebo, than atomoxetin |
| Placebos14-day treatment interval: first week one placebo pill, second week two placebo pills | Drug | First atomoxetin, than placebo, First placebo, than atomoxetin |
Primary outcome
FMRT resting state connecitivty of the default mode network
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Individual participant dataSharing planned: Yes. Data will be uploaded into the data pool of the Deutsches Netzwerk zu psychischen Erkrankungen.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ADHD, run by RWTH Aachen University at 1 site 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 1 inclusion and 1 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 7 Sep 2018. 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 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
FMRT resting state connecitivty of the default mode network (time frame: 4 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 7 Sep 2018.