Attention Deficit Hyperactivity DisorderPhase 4DrivPerfATXNCT00938743
Driving in Adults With Attention-deficit/Hyperactivity Disorder (ADHD) Before and During Treatment With Atomoxetine
A Phase 4 study testing Atomoxetine in people with Attention Deficit Hyperactivity Disorder, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
Trial summary
According available data individuals with ADHD are impaired in their driving ability which can be improved by stimulant medication. The impact of the specific noradrenalin-reuptake-inhibitor atomoxetine on driving ability of patients with ADHD has never been studied so far. Read more about this study
- Who is it for?
- Ages 18 to 55 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
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2008to Dec 2009
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Informed Consent Form signed by the patients.
- Patients are 16-50 years of age when the informed consent document is obtained (Visit 1).
- Patients have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including venipuncture and examinations, required by the protocol.
- Patients must meet DSM-IV-TR criteria for ADHD assessed by the Conners' Adult ADHD Diagnostic Interview for DSM-IV (CAADID) and KIDDIE-SADDS-PL respectively and according to expert consensus.
- Patients must also have a significant other evaluation of their current ADHD using the Conners' Adult ADHD Rating Scale Observer: Screening Version (CAARS-O: SV) and Conners' Rating Scales- Revised (CRS-R):SV respectively
- Patients must have a CGI-ADHD-S score of more than 4 points (moderate symptoms) at Visit 1.
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- Patients aged 18 and older must have a valid driver's license.
- Patients must have laboratory results assessed at Visit 1, including serum chemistries, haematology, and thyroid function, that show no significant abnormalities. Significant would include laboratory deviations requiring acute medical intervention or further medical evaluation.
- Patients must have a negative urinary drug screen at Visit 1.
- Patients must have no medical history of heart disease that could be destabilized by increases in heart rate or blood pressure. The screening electrocardiogram (ECG) performed at Visit 1 must not show significant abnormalities. Significant would include a heart rate of less than 40 bpm and more than 120 bpm respectively, any disturbances in rhythm and conduction as well as ECG-findings pointing to myocardial infarction.
- Females of childbearing potential defined as women not surgically sterilized and between menarche and 1 year post-menopause must test negative for pregnancy at Visit 1 based on an urinary pregnancy test and agree to use a reliable method of birth control (e.g., oral contraceptives, a reliable barrier method of birth control like diaphragms, intrauterine devices; partner with vasectomy or abstinence) during the study.
Who cannot join
- The exclusion criteria are designed to eliminate patients who do not meet study population criteria or whose participation in the study would be inappropriate due to underlying safety issues and to ensure that patients participating in the study are in a stable physical condition. They further are designed to maintain consistency with the approved global labeling for atomoxetine.
- Patients will be excluded from the study if they meet any of the following criteria:
- Patients who are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- Patients who meet full DSM-IV diagnostic criteria for any history of bipolar or psychotic disorder, current major depression, current generalized anxiety disorder or panic disorder will be excluded from the study. Assessment will be done by clinical history and a Structured Clinical Interview for DSM-IV Axis-I disorders (SCID).
- Patients who are currently using alcohol, drugs of abuse, or any prescribed or over-the-counter medication in a manner which the investigator considers indicative of abuse or who meet DSM-IV-TR criteria for substance abuse, assessed by clinical history and a Structured Clinical Interview for DSM-IV (SCID). Patients must not use drugs of abuse or illicitly obtained prescription drugs during the study, and a urine drug screen may be obtained at any time during the study. Alcohol use should be discouraged, and if, in the investigator's judgment, the patient is using alcohol to excess, the patient should be discontinued.
- Patients, who in the opinion of the investigator, are at serious suicidal or homicidal risk.
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- Patients with organic brain disease, for example, dementia, traumatic brain injury residual, or a history of any seizure disorder (except febrile seizures during childhood).
- Patients with a history of severe allergies to more than one class of medications or multiple adverse drug reactions.
- Patients who have a known history of narrow angle glaucoma.
- Males with prostatic symptoms.
- Patients with significant medical conditions that are likely to become unstable during the trial or would likely be destabilized by treatment with atomoxetine, (for example, cardiovascular disease that would be at aggravated by increased heart-rate), or require treatment with excluded medications.
- Patients who have any medical condition or who are taking a medication on a daily basis (for example albuterol, inhalation aerosols) that has sympathomimetic activity.
- Patients with hypertension. For the purposes of this protocol, hypertension will be defined as average systolic or diastolic blood pressure, measured on at least 2 separate occasions, greater than or equal to 140/90. Patients whose blood pressure is controlled with non-excluded medication are eligible for inclusion.
- Patient taking any psychotropic medications on a daily basis within 2 weeks before Visit1. However, zolpidem to a dose of 10 mg may be used intermittently as needed for insomnia provided they are not used more than 3 times weekly.
- Patients who have received regular treatment within the last 30 days with a drug that has not received regulatory approval for any indication or taking any antipsychotic medication at the time of study entry.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Central Institute of Mental Health, Adult ADHD Outpatient Department
Mannheim
About this study
Official title: Driving Ability in Adults With ADHD Before and After 10-weeks of Treatment With 40-80mg Atomoxetine vs. Untreated Adults With ADHD
According available data individuals with ADHD are impaired in their driving ability which can be improved by stimulant medication. The impact of the specific noradrenalin-reuptake-inhibitor atomoxetine on driving ability of patients with ADHD has never been studied so far.
The present study aims to evaluate the effects of atomoxetine treatment in patients with ADHD on practical driving abilities which will be assessed with a standardized driving test, a structured one-week driving diary and driving related neuropsychological processing especially different aspects of attention and executive functions which will be assessed with a neuropsychological test battery designed for the assessment of drivers fitness. A functional magnetic resonance imaging (fMRI) - investigation will also be performed at the beginning and after a 10-week treatment with atomoxetine. The study will be conducted in a single-blind placebo controlled parallel group design in cooperation of the academic Adult ADHD-outpatient clinics of the Central Institute of Mental Health, Mannheim and the Institute of Legal and Traffic Medicine of the University of Heidelberg, Germany.
It is expected that treatment with atomoxetine will improve practical driving abilities and driving related neuropsychological processing. It is expected that risk taking and impulsive decision making will be reduced and sustained attention and overview of complex traffic situations will be improved while driving.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Atomoxetine
- Keywords
- ADHD, adults, driving performance, 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
40-80 mg atomoxetine once daily, including titration 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Atomoxetine | Active comparator | Treatment with a final dosis of 40-80mg atomoxetine daily Receives: Drug: Atomoxetine |
| Waiting list | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized practical driving test
Measured: 1/2010
Secondary outcomes (3)
Action-Reaction-Test Battery
Measured: 1/2010
Performance criteria for drivers' fitness according to the "Guidelines of Driver Fitness"
Measured: 1/2010
Safety measures including vital signs, laboratory test, ECG, assessment of SAEs
Measured: 1/2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2009 (estimated)
- Study startJan 2008
- Primary completionDec 2009
- Study completionDec 2009
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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938743
- Sponsor's protocol ID
- 2007-004309-90
- Acronym
- DrivPerfATX
- Status last verified
- Jan 2011
- First submitted
- 13 Jul 2009
- Last updated
- 20 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Driving Ability in Adults With ADHD Before and After 10-weeks of Treatment With 40-80mg Atomoxetine vs. Untreated Adults With ADHD
- ClinicalTrials.gov ID
- NCT00938743
- Acronym / sponsor ID
- DrivPerfATX / 2007-004309-90
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, adults, driving performance, atomoxetine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Collaborators
- Heidelberg University
- Study start
- Jan 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 14 Jul 2009 (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.
According available data individuals with ADHD are impaired in their driving ability which can be improved by stimulant medication. The impact of the specific noradrenalin-reuptake-inhibitor atomoxetine on driving ability of patients with ADHD has never been studied so far.
The present study aims to evaluate the effects of atomoxetine treatment in patients with ADHD on practical driving abilities which will be assessed with a standardized driving test, a structured one-week driving diary and driving related neuropsychological processing especially different aspects of attention and executive functions which will be assessed with a neuropsychological test battery designed for the assessment of drivers fitness. A functional magnetic resonance imaging (fMRI) - investigation will also be performed at the beginning and after a 10-week treatment with atomoxetine. The study will be conducted in a single-blind placebo controlled parallel group design in cooperation of the academic Adult ADHD-outpatient clinics of the Central Institute of Mental Health, Mannheim and the Institute of Legal and Traffic Medicine of the University of Heidelberg, Germany.
It is expected that treatment with atomoxetine will improve practical driving abilities and driving related neuropsychological processing. It is expected that risk taking and impulsive decision making will be reduced and sustained attention and overview of complex traffic situations will be improved while driving.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atomoxetine | Active comparator | Drug: AtomoxetineTreatment with a final dosis of 40-80mg atomoxetine daily |
| Waiting list | No intervention | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Informed Consent Form signed by the patients.
- Patients are 16-50 years of age when the informed consent document is obtained (Visit 1).
- Patients have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including venipuncture and examinations, required by the protocol.
- Patients must meet DSM-IV-TR criteria for ADHD assessed by the Conners' Adult ADHD Diagnostic Interview for DSM-IV (CAADID) and KIDDIE-SADDS-PL respectively and according to expert consensus.
- Patients must also have a significant other evaluation of their current ADHD using the Conners' Adult ADHD Rating Scale Observer: Screening Version (CAARS-O: SV) and Conners' Rating Scales- Revised (CRS-R):SV respectively
Key exclusion criteria (15 listed)
- The exclusion criteria are designed to eliminate patients who do not meet study population criteria or whose participation in the study would be inappropriate due to underlying safety issues and to ensure that patients participating in the study are in a stable physical condition. They further are designed to maintain consistency with the approved global labeling for atomoxetine.
- Patients who are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- Patients who meet full DSM-IV diagnostic criteria for any history of bipolar or psychotic disorder, current major depression, current generalized anxiety disorder or panic disorder will be excluded from the study. Assessment will be done by clinical history and a Structured Clinical Interview for DSM-IV Axis-I disorders (SCID).
- Patients who are currently using alcohol, drugs of abuse, or any prescribed or over-the-counter medication in a manner which the investigator considers indicative of abuse or who meet DSM-IV-TR criteria for substance abuse, assessed by clinical history and a Structured Clinical Interview for DSM-IV (SCID). Patients must not use drugs of abuse or illicitly obtained prescription drugs during the study, and a urine drug screen may be obtained at any time during the study. Alcohol use should be discouraged, and if, in the investigator's judgment, the patient is using alcohol to excess, the patient should be discontinued.
- Patients, who in the opinion of the investigator, are at serious suicidal or homicidal risk.
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 |
|---|---|---|
| Atomoxetine40-80 mg atomoxetine once daily, including titration 10 weeks | Drug | Atomoxetine |
Primary outcome
Standardized practical driving test
Time frame: 1/2010
3 secondary outcomes
Action-Reaction-Test Battery
Time frame: 1/2010
Performance criteria for drivers' fitness according to the "Guidelines of Driver Fitness"
Time frame: 1/2010
Safety measures including vital signs, laboratory test, ECG, assessment of SAEs
Time frame: 1/2010
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 20 Jan 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.
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 Attention Deficit Hyperactivity Disorder, run by Central Institute of Mental Health, Mannheim 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 11 inclusion and 15 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 20 Jan 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 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?
Standardized practical driving test (time frame: 1/2010). 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 Jan 2011.