E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
emotional information processing.
(Disease of interest is depression, however this trial is in healthy volunteers; we will use a test battery that has previously been shown sensitive to the administration of antidepressant medication in healthy volunteers). |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10057840 |
E.1.2 | Term | Major depression |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012378 |
E.1.2 | Term | Depression |
|
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 |
In healthy individuals, study the effects of a single dose of ARA290 on the cognitive and neural processing of emotions. |
|
E.2.2 | Secondary objectives of the trial |
In healthy individuals, study the effects of a single dose of ARA290 on subjective mood state and memory, attention and speed of information processing. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Dutch-speaking • Age 18-35 • Right-handedness • BMI 18 to 33 kg/m2
|
|
E.4 | Principal exclusion criteria |
• Major physical illness, such as diabetes, thyroid disease, epilepsy, stroke, multiple sclerosis, pituitary disease, or any other serious medical condition. • Any current or past psychiatric disorder, as determined by a MINI International Neuropsychiatric Interview (MINI), including subclinical claustrophobia if severe enough to cause anxiety during scanning. • Using medication likely to interfere with the study, including OTC (over the counter) medication (e.g., St John’s Wort) and benzodiazepines. • Pregnancy or breastfeeding • Use of any nicotine products or soft drugs (hash, marihuana) in the three months prior to the study. • Any hard drug use (including XTC) (lifetime) • Alcohol use of more than 14 units per week or more than 4 units on any day during the week prior to the study or during the study period. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
• Accuracy and speed to recognize facial expressions of emotions • Number of positive personal descriptions recalled in a memory task • Decision making as assessed with computerized social cognitive test • Neural processing of emotions, in particular amygdala, hippocampal and ventromedial prefrontal cortex (VMPFC) response to viewing facial stimuli expressing a negative or positive emotion. • Functional brain connectivity of brain regions expected to be affected: amygdala and VMPFC. |
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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 | Yes |
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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
E.8.1.6 | Cross over | No |
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.8.3 |
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 | Information not present in EudraCT |
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
|
End of the trial will be the last visit of the last participant. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |