Inhaled Oxytocin and HPA Axis Reactivity
Depression, Postpartum · Anxiety Disorders · Stress, Psychological
Bottom Line
View on ClinicalTrials.gov: NCT03593473 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Intranasal Oxytocin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Cortisol (CRT) During Trier Social Stress Test (TSST) |
19.17; 16.87; 15.71; 13.89; 14.06; 13.03 | 0.37 |
| SECONDARY Mean Adrenocorticotropic Hormone (ACTH ) During TSST |
79.96; 86.77; 85.73; 87.61; 84.31; 86.10 | 0.71 |
| SECONDARY Lagged Association Between ACTH and CRT During the TSST |
0.07; 0.44; 0.04; 0.31; 0.16; 0.46 | 0.07 |
| SECONDARY Changes in High Frequency Respiratory Sinus Arrhythmia Power, an Index of Parasympathetic Activity, During the TSST |
9.4867; 25.2298; -54.8211; -76.7692; 25.9791; -34.2107 | 0.8441 |
| SECONDARY Changes in Pre-ejection Period, an Index of Sympathetic Activity, During the TSST |
-0.0133; -0.5344; -0.4379; -1.578; -0.0765; -1.2421 | 0.6452 |
Summary
Eligibility Criteria
This study will follow-up the existing Mood, Mother and Infant (MMI) prospective longitudinal cohort (R01HD073220), comprised of 222 mother-infant dyads who were recruited between May 2013 and April 2017 and completed the 12-month MMI visit. In the MMI study, 222 mothers ages 18-45 and their infants were enrolled. Participants were recruited from community clinics in the third trimester of pregnancy and continued to participate in the study through 12 months postpartum. At the 12-month visit, mothers were invited to continue to be followed via online surveys at 6-month intervals; more than 80% of women who have completed the MMI study to date have continued to participate. Enrolled participants in the MMI study met the following inclusion and exclusion criteria:
Inclusion Criteria
- Singleton pregnancy;
- Intention to breastfeed (due to the centrality of breastfeeding to the oxytocin assessment);
- Intention to remain within 40 miles of the University of North Carolina - Chapel Hill through infant's first birthday;
- Ability to communicate in English.
Exclusion Criteria
- Maternal diagnosis of Axis I disorders other than unipolar depression or anxiety disorders. Women with a history of bipolar disorder were excluded, given their increased risk of postpartum psychosis.
- Active substance abuse at enrollment in the 3rd trimester of pregnancy (Tobacco, alcohol, illicit substances);
- Major congenital anomaly;
- Chronic medication/medical condition contraindicated for breastfeeding;
- Current use of tricyclic antidepressants, which alter cortisol and heart rate variability.
At enrollment, all participants underwent a Structured Clinical Interview Non-Patient version (SCID-NP).
Inclusion Criteria for Inhaled Oxytocin and HPA Axis Reactivity, a substudy of the Psychobiology of Resilience in Mother-Child Pairs follow-up study: 1) Participated in the MMI study 2) Both mother and child willing and able to participate in the 6-year follow-up visits 3) Not pregnant, verified by urine pregnancy test on day of study visit.
Data sourced from ClinicalTrials.gov (NCT03593473). 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.