E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with Attention-Deficit/Hyperactivity Disorders (ADHD) |
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E.1.1.1 | Medical condition in easily understood language |
Patients with ADHD which is a disorders causing inattention, hyperactivity and impulsivity |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective is to assess the changes in DMN connectivity and in fMRI BOLD response in patients with ADHD compared to healthy controls during a 2 week treatment with atomoxetine. Atomoxetine is proven to normalize the brain activity of patients with ADHD and improves their cognitive performance.
One of the main aims of our study is to improve our knowledge about ADHD and its underlying neurophysiological mechanisms of functioning. Furthermore, we are planning to examine the meaning of normalized DMN activity and reward processing of patients with ADHD for an improved cognitive performance. Moreover, we are confident that the results of our study will enable us to make new interferences for future psychotherapeutic treatment.
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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
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E.4 | Principal exclusion criteria |
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
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E.5 End points |
E.5.1 | Primary end point(s) |
To examine the influence of atomoxetine related changes in brain activity on cognitive performance in patients with ADHD compared to controls. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
end of the second fMRI session |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
We are just planning to manipulate brain activity in patients with ADHD compared to controls by treating them with atomoxetine. This will help us to gain some new insights into the neurophysiological mechanism associated with aberrant cognitive functioning in patients with ADHD. |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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- severe side effects due to the intake of atomoxetine requiring an immediate stopp
- other acute clinical conditions requiring an immediate treatment
- positive drug screening |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |