Oxytocin, friendship and dealing with emotions

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2017
INTERVENTION: Trade Name: Syntocinon nasal spray Product Name: Syntocinon Product Code: RVG 03716 Pharmaceutical Form: Nasal spray INN or Proposed INN: OXYTOCIN CAS Number: 50‐56‐6 Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 24‐ Pharmaceutical form of the placebo: Nasal spray Route of administration of the placebo: Nasal use CONDITION: Therapeutic area: Psychiatry and Psychology [F] ‐ Psychological processes [F02] There are no medical conditions or disease under investigation. PRIMARY OUTCOME: Main Objective: Main objective is to examine effects of oxytocin on stress reactivity Primary end point(s): stress reactivity: heart rate reactivity, salivary cortisol levels and subjective stress measured with questionnaires.; Stress reactivity of 4 groups of participants will be measured:; 1) participants who receive intranasal oxytocin and receive social support from a friend during stress; 2) participants who receive intranasal oxytocin and who do not receive social support from a friend during stress; 3) participants who receive a placebo and receive social support from a friend during stress; 4) participants who receive a placebooxytocin and who do not receive social support from a friend during stress; ; Expected end point: reduced stress reactivity in the oxytocin condition, with most pronounced oxytocin effects when there is social support from a friend Secondary Objective: Combined effects of oxytocin and social support on stress reactivity: to examine whether oxytocin enhances the beneficial effects of social support Timepoint(s) of evaluation of this end point: we will examine effects of intranasal oxytocin on stress reactivity during a social stress test (a virtual version of the Trier Social Stress Test) and a physical stress test (the Cold Pressor Test). Stress levels will be measured before oxytocin administration, immediately after administration, during the stress tests and afterwards. Saliva will be collected to measure cortisol, heart rate will be measured with the VU‐AMS device, and subjective stress will be measured with questionnaires. SECONDARY OUTCOME: Secondary end point(s): not applicable Timepoint(s) of evaluation of this end point: we will examine effects of oxytocin on stress reactivity during a social stress test and a physical stress test. Stress levels will be measured before oxytocin administration, immediately after administration, during the stress tests and afterwards. INCLUSION CRITERIA: 18‐30 years, women 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 180 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Epistemonikos ID: 160517617e6b1191f03adc06750309ca99c86bac
First added on: Aug 23, 2024