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The effects of ARA290 on the cognitive and neural processing of emotions in healthy volunteers - Cognitive and neural effects of ARA290

The effects of ARA290 on the cognitive and neural processing of emotions in healthy volunteers - Cognitive and neural effects of ARA290

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-024364-18-NL
Enrollment
Unknown
Registered
2011-01-06
Start date
2011-04-12
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

emotional information processing. (Disease of interest is depression, however this trial is in healthy volunteers

Interventions

Product Name: ARA290 Product Code: ARA290 Pharmaceutical Form: Solution for infusion Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use

Sponsors

Leiden University
Lead Sponsor
Leiden University Medical Center
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • Dutch-speaking • Age 18-35 • Right-handedness • BMI 18 to 33 kg/m2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Main Objective: In healthy individuals, study the effects of a single dose of ARA290 on the cognitive and neural processing of emotions. ;Secondary Objective: In healthy individuals, study the effects of a single dose of ARA290 on subjective mood state and memory, attention and speed of information processing. ;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.—

Countries

Netherlands

Outcome results

None listed

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