N/A
N=449
Biological Basis of Individual Variation in Social Cooperation
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01566539 ↗Enrolled (actual)
449
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Men — 0.21; 0.07 percent signal change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intranasal Oxytocin (OT) 24 IU (Drug); Intranasal Vasopressin (AVP) (Drug); Intranasal Placebo (Drug); Intranasal Vasopressin (AVP) 40 IU (Drug); Lorazepam (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Men |
0.21; 0.07 | — |
| PRIMARY Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Women |
0.04; 0.15 | — |
| PRIMARY Healthy Volunteers-AVP, Placebo: Mean Percent Signal Change in Left Insula in Men |
0.13; -0.02 | — |
| PRIMARY Healthy Volunteers-AVP, Placebo: Mean Percent Signal Change in Left Insula in Women |
-0.05; 0.10 | — |
| PRIMARY Within Subject Group: Mean Percent Signal Change in Left Caudate Nucleus in Men and Women |
0.21; 0.19; 0.06; 0.10 | — |
| SECONDARY Healthy Volunteer Groups: Total Number of Cooperate Choices Made by Men During the Prisoners Dilemma Game |
15.71; 16.18; 17.68 | — |
| SECONDARY Healthy Volunteer Groups: Total Number of Cooperate Choices Made by Women During the Prisoners Dilemma Game |
15.84; 18.14; 16.92 | — |
| SECONDARY Within Subject Group: Mean Difference in Number of Cooperate Choices Made by Male During the Prisoners Dilemma Game |
-1.10 | — |
| SECONDARY Within Subject Group: Mean Difference in Number of Cooperate Choices Made by Female During the Prisoners Dilemma Game |
16.13; 15.53 | — |
| SECONDARY Faces Task Groups: Mean Percent Signal Change in Nucleus Accumbens to Faces in Men |
0.03; -0.14; 0.14; -0.13 | — |
| SECONDARY Faces Task Groups: Mean Percent Signal Change in Nucleus Accumbens to Faces in Women |
-0.08; 0.12; 0.003; 0.13 | — |
| SECONDARY Faces Task Groups: Mean Approachability Rating of Faces in Men |
0.31; -0.06; 1.00; 0.81; 0.78; 0.25 | — |
| SECONDARY Faces Task Group: Mean Approachability Rating of Faces in Women |
0.37; 0.21; -0.04; 0.28; 0.37; 0.23 | — |
| SECONDARY Faces Task Groups: Mean Attractiveness Rating of Faces in Men |
0.35; -0.06; 1.79; 1.60; 0.52; -0.08 | — |
| SECONDARY Faces Task Groups: Mean Attractiveness Rating of Faces in Women |
1.56; 1.02; 0.55; 0.61; 1.29; 0.82 | — |
| SECONDARY Empathy Task Groups: Mean Percent Signal Change in Early Visual Cortex in Response to Animation in Women |
-.910; -.377 | — |
| SECONDARY Empathy Task Groups: Mean Percent Signal Change in Early Visual Cortex in Response to Animation in Men |
-.429; -.382 | — |
Summary
The project has three overall objectives. The first is to determine whether and how administration of intranasal oxytocin (OT) and intranasal vasopressin (AVP) influence cooperative decision-making and neural responses to cooperative and un-cooperative social interactions. The second is to determine whether and how intranasal vasopressin influences subjective evaluations of and neural responses to same and opposite-sex face stimuli and to determine if any of these effects persist beyond the period of AVP exposure. The third objective is to determine if intranasal OT influences empathy-related behavior and associated brain activity.
Eligibility Criteria
Inclusion Criteria
- 18-30 years of age
- 21-30 for Faces component
- Normal or corrected-to-normal vision of 20/40
- Unmedicated depressed or anxious men between 18-22 years of age for Anxious and Depressed component
Exclusion Criteria
- Pregnancy, recent birth, or breastfeeding
- History of seizures
- Neurological Disorder
- Current psychiatric disorder
- Previous psychiatric disorder (can be included as discretion of PI)
- Current use of psychoactive drugs
- Previous use of psychoactive drugs (can be included as discretion of PI)
- Previous head trauma (can be included at discretion of PI)
- Alcoholism or substance abuse
- Hypertension
- Cardiovascular Disease
- Nephritis
- Diabetes
- Endocrine disease or malignancy
- Asthma (can be included as discretion of PI, if episodes are infrequent, nonmedicated, and no active problems at time of study)
- Migraines (can be included as discretion of PI, if episodes are infrequent, nonmedicated, and no active problems at time of study)
- Claustrophobia (at discretion of PI)
Additional exclusion criteria for Lorazepam arm
- Acute narrow-angle glaucoma
- Compromised respiratory function (e.g. sleep apnea and chronic obstructive pulmonary disease)
- Impaired renal and hepatic function
Data sourced from ClinicalTrials.gov (NCT01566539). 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.