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Phase 1 N=21 Randomized Quadruple-blind Basic Science

Brain Dynamics of Oxytocin

Brain Dynamics in Healthy Adults

Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Number of Benevolent Rounds — 6.8; 6.8 number of rounds

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
Syntocinon Nasal Spray, 40IU (Drug); Syntocinon Placebo Formulation, 40IU (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Stony Brook University
Primary completion
May 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Benevolent Rounds
6.8; 6.8
PRIMARY
Number of Malevolent Rounds
2.8; 3.0
SECONDARY
Functional Connectivity Between OFC and AMY
0.45; 0.18

Summary

Oxytocin is a neuropeptide that is well known for its role in social and affiliative behavior in humans. Oxytocin receptors are significantly lowered in autistic individuals and administration of oxytocin has shown benefits in enhancing social recognition and behavior in autistic children. However, more recent research has refined the behavioral effects of oxytocin, moving away from the notion that the neuropeptide blindly induces love and trust, towards the view that it actually increases social perception in assessing friend vs. foe: supporting cohesion with 'insiders' and distrust and aggression for 'outsiders.' Oxytocin is responsible for the selective aggression shown by lactating female mammals protecting their young, an effect demonstrated also in humans, and has been shown to strengthen feelings of ethnocentrism. However, no neuroimaging study to date has investigated this effect, with the consequence that its neurobiological basis is still unknown. The general aim of our study is to determine meso-circuit brain dynamics that underlie oxytocin's amplification of both trust and aggression; and specifically, using neuroimaging (fMRI, magnetoencephalography, and behavioral testing) whether oxytocin amplifies kinship bias by attenuating social reward learning.

Eligibility Criteria

Inclusion Criteria

  • 18-45 years of age

Exclusion Criteria

  • any significant known medical condition, including mental disorders (confounds interpretation of brain activity)
  • metal in the body or claustrophobia (contraindicated for fMRI)
  • current use of any type of psychotropic medication (confounds interpretation of brain activity)
  • body mass index of greater than 30 (to permit matched dosing across subjects)
  • pregnancy (contraindicated for OT)
  • breastfeeding (lactation endogenously triggers OT, which would not permit a placebo condition)
  • smoking (affects use of nasal spray)
  • use of drugs of abuse (confounds interpretation of brain activity)
  • blood pressure above the normal range (140/90 mm Hg) or controlled with medication (may theoretically increase risk for OT side-effects)
  • anosmia (affects use of nasal spray)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01834261). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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