N/A
N=270
The Biology of Resilience
Oxytocin · Placebo
Bottom Line
View on ClinicalTrials.gov: NCT01011465 ↗Enrolled (actual)
270
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcome: Primary: Systolic Blood Pressure Change From Baseline to Second Stress Task Experience - Autonomic Stress Response Measure — 9.4; 12.9; 11.3; 11.1 mm Hg — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- intranasal oxytocin (Drug); Placebo (Drug); Social support (Behavioral); No Social Support (Behavioral)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Harvard School of Public Health (HSPH)
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Systolic Blood Pressure Change From Baseline to Second Stress Task Experience - Autonomic Stress Response Measure |
9.4; 12.9; 11.3; 11.1; 10.7; 11.7 | 0.03 sig |
| PRIMARY Difference of Pre-count and Baseline Self-reported Negative Affect (Using Negative Sub-scale of Positive and Negative Affect Schedule (PANAS) Measure). |
1.4; 1.8; 2.1; 1.2; 1.8; 1.2 | 0.43 |
| PRIMARY Speech Threat and Challenge |
4.6; 4.6; 4.5; 4.6; 4.6; 4.6 | 0.83 |
Summary
Positive social relationships have consistently been associated with better health, although the neurobiological underpinnings of these observed effects remain largely unknown. The overall goal of the proposed work is to explore novel biological pathways that may explain how social relationships influence health. Recent theorizing suggests that the oxytocin system may underlie some of the observed beneficial effects. Four hypotheses will be examined:
1. Oxytocin ameliorates the deleterious neuroendocrine, cardiovascular, and subjective effects of stress.
2. Oxytocin and social support have similar and additive stress-buffering effects.
3. Effects of oxytocin are evident among younger and older adults.
4. Effects of oxytocin are stronger in women vs men.
Eligibility Criteria
Inclusion Criteria
- age 22-65, BMI 140/90 mm Hg
- subject does not have a close friend available to participate in the study with him/her
Data sourced from ClinicalTrials.gov (NCT01011465). 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.