Validation of a human version of the rodent approach/avoidance conflict model Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Informed Consent as documented by signature 2. Age 18 – 40 years
Exclusion criteria
Exclusion criteria: 1. Contraindications to benzodiazepines: dependence or former dependence, history of allergic reactions, history of hypotonia associated with benzodiazepines 2. Use of any drugs in the 2 weeks prior to the study with the exception of contraceptive drugs and incidental use of NSARs or paracetamol 3. Women who are pregnant or breast feeding 4. Intention to become pregnant during the course of the study 5. Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases 6. Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) 7. Any history of psychiatric, neurological, dependence or systemic/rheumatic disease 8. Known or suspected non-compliance, drug or alcohol abuse 9. Inability to follow the procedures of the study, e.g. due to language problems 10. Participation in another study with investigational drug within the 30 days preceding and during the present study 11. Previous enrolment into the current study 12. Members of the study team and their family members and dependents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is the overall probability of being in the safe quadrant in the computer game. Probability of being in the safe quadrant will be assessed over all rounds of the experiment and analysed in a time x task x threat level factorial design. Probability of being in the safe quadrant is a surrogate marker for passive avoidance, and was highly sensitive in distinguishing between patients with hippocampal lesions and healthy controls in a previous study. Measured during the entire computer game (average behaviour in the computer game). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are distance from threat, distance from walls, probability of being in the threat quadrant, probability of being in the safe place, rate of token collection and speed when on grid, in the computer game. All secondary outcomes will be assessed over all rounds of the experiment and analyzed in a time x task x threat level factorial design. Measured during the entire computer game (average behaviour in the computer game). | — |
Countries
Switzerland