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Studying the impact of Lorazepam on approach/avoidance behaviour in healthy individuals

A randomised, double-blind, placebo-controlled study on the impact of Lorazepam on approach/avoidance behaviour in healthy individuals

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12590498
Enrollment
60
Registered
2014-12-08
Start date
2014-12-01
Completion date
Unknown
Last updated
2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Validation of a human version of the rodent approach/avoidance conflict model Mental and Behavioural Disorders

Interventions

A single dose 1 mg of lorazepam or placebo Approach/avoidance behaviour task: We have developed a human approach-avoidance task that emulates rodent anxiety paradigms

Sponsors

Psychiatric University Hospital (Psychiatrische Universitätsklinik) Zürich (PUK ZH)
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026