There are no medical conditions or diseases under investigation.
Conditions
Interventions
Trade Name: Sinemet
Product Name: Sinemet
Product Code: RVG 08740
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: healthy, female, 18 years old or older, of caucasian descent 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 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: pregnancy, breastfeeding, drug or alcohol abuse, prior psychiatric or neurological disorder,use of medication (except oral contraceptives), existing medical condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We aim to investigate whether the dopamine receptor D4 (DRD4) genotype confers differential susceptibility to the effects of early life stress, on caregiving behavior in adults. We also aim to study whether DRD4 genotype and resting frontal asymmetry confer differential susceptibility to effects of a dopaminergic pharmacological intervention on caregiving-related neurocognitive processes, behaviors, and attitudes. The following questions will be addressed: 1. What is the relationship between DRD4 genotype and adult empathy and prosocial behavior, and does early life experience moderate this effect? 2. What is the effect of L-Dopa administration (a pharmacological intervention that heightens levels of dopamine) on parenting-related neurocognitive processes, behaviors, and attitudes? 3. Does the DRD4 genotype moderate the efficacy of the pharmacological intervention? 4. Can resting frontal asymmetry serve as an endophenotype for differential susceptibility? ;Secondary Objective: Rigorous statistical probing will be conducted, including the use of simulations to test the integrity of the data. Results of these statistical assessments will be used to correct the data accordingly. These analyses will help to improve the quality of data-analysis and conclusions, and provide statistical guidelines for future data-analysis of similar designs.;Primary end point(s): -Theory of Mind. An adult version of the Reading the Mind in the Eyes Test will be carried out, to determine the baseline level of interpretation of emotion. -Prosociality. - Resting frontal asymmetry. Participants’ resting EEG will be recorded and an asymmetry index will be computed (see below). As described above, we will investigate whether resting frontal alpha asymmetry can be considered an endophenotype for differential susceptibility. - Neural indices of the processing of and attention to infant faces and sounds. ERP components indicative of processing depth and attention will be computed | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Self-reported caregiving attitudes and empathy. We will investigate whether L-Dopa administration affects questionnaire measures (see below) of empathy and caregiving attitudes, and whether potential effects are moderated by genotype and resting frontal asymmetry.;Timepoint(s) of evaluation of this end point: Secondary parameters will be assessed during the same two identical experimental sessions, separated by 4 weeks. | — |
Countries
Netherlands
Outcome results
None listed