E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
There are no medical conditions or diseases under investigation. |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Not possible to specify |
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 goal of the study is to investigate if small amounts of dopamine could influence engagement during reading, comprehension of the story and vocabulary learning and to investigate if the effect of dopamine is different for carriers of the long or short variant of the DRD4 gene. Additionally, the effect of dopamine on how participants value reading is investigated. |
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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 |
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E.4 | Principal exclusion criteria |
- Serious reading problems (dyslexia)
- Medical illness, indicating a risk in using haloperidol (e.g., cardiac illness, depression, thyroid disorders, glaucoma)
- Current or recent use (<2 weeks before participation) of psycho-pharmacological medication (other than contraceptives), psychotropic drugs or drugs that might interfere with haloperidol.
- Known drugs allergies
- Pregnancy or lactation |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Task engagement: Index score for task engagement from EEG (beta/(alpha + theta))
- Story comprehension: Results for the comprehension questions
- Vocabulary: Results for the vocabulary measure
- Reading resistance: Presence or absence of attentional bias for reading related stimuli on the dot-probe task and/or the emotional Stroop task.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Task engagement is measured during reading. Story comprehension, vocabulary and reading resistance are measured immediatley after reading the text. |
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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 aim to investigate if dopamine functioning influences reading motivation and achievement and if there is a differential susceptibility to the effects of a rise in dopamine levels, based on the genotype for the dopamine receptor gene DRD4. |
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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 | 1 |
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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LVLS (last visit of the last subject undergoing the trial) |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |