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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Inhaled Oxytocin and HPA Axis Reactivity

NCTNCT03593473 (opens ClinicalTrials.gov in a new tab)Other id12-2061Other idR01HD093901-01A1
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
109 participants (actual)
Sponsor
University of North Carolina, Chapel Hill · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
7 Feb 2019
Primary completion
25 Jul 2023
Completion
25 Jul 2023
First posted
20 Jul 2018
Last update posted
8 Aug 2025
Conditions
Depression, Postpartum · Anxiety Disorders · Stress, Psychological

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021202220232024
  1. Ph 2

    Inhaled Oxytocin and HPA Axis Reactivity

    NCT03593473

    7 Feb 2019 to 25 Jul 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Mothers who were enrolled in the Mood, Mother and Infant study will be eligible to participate in the 6-year follow-up maternal visit. At the time of this visit, mothers will be randomized to a single 24 IU dose of nasal oxytocin or placebo. Following administration of the study drug, women will participate in the Trier Social Stress Test (TSST), and blood samples will be collected to quantify HPA axis reactivity.

Interventions

  • Intranasal OxytocinDrug
  • PlaceboDrug

Arms2

  • Experimental

    Intranasal Oxytocin

    Participants block randomized to Oxytocin intranasal spray by risk status at enrollment in the Mood, Mother and Infant (MMI) study and as verified by structured clinical diagnostic interview (no history of depression or anxiety, past depression or anxiety, current depression or anxiety).

  • Placebo comparator

    Placebo

    Participants block randomized to placebo Intranasal spray with all equivalent ingredients except oxytocin. Blocks will be stratified by risk status at enrollment in the Mood, Mother and Infant (MMI) study and as verified by structured clinical diagnostic interview (no history of depression or anxiety, past depression or anxiety, current depression or anxiety).

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Mean Cortisol (CRT) During Trier Social Stress Test (TSST)

    Time frame · -40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutes

    Registry description

    The study drug will be administered 40 minutes before the TSST. Serum cortisol will be measured via peripheral IV 40 (-40) and 20 (-20) minutes before the TSST, at the start of the TSST (0 minutes), and at minutes 10 (during the speech task), 15 (during the math task), 28, 38, and 48 (during recovery).

Secondary outcomes(4)

  1. Mean Adrenocorticotropic Hormone (ACTH ) During TSST

    Time frame · -40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutes

    Registry description

    The study drug will be administered 40 minutes before the TSST. Adrenocorticotropic hormone will be measured via peripheral IV 40 (-40) and 20 (-20) minutes before the TSST, at the start of the TSST (0 minutes), and at minutes 10 (during the speech task), 15 (during the math task), 28, 38, and 48 (during recovery).

  2. Lagged Association Between ACTH and CRT During the TSST

    Time frame · ACTH at -40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes and Cortisol at -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutes

    Registry description

    Correlations will be quantified between ACTH at time j and CRT at time j+1 to test the extent to which CRT response is blunted by exogenous oxytocin (OT).

  3. Changes in High Frequency Respiratory Sinus Arrhythmia Power, an Index of Parasympathetic Activity, During the TSST

    Time frame · Minutes -40 to -35, -35 to -30, -30 to -25, -25 to -20, -20 to -15, -15 to -10, -10 to -5, -5 to 0, 5 to 8, 8 to 13, 13 to 18, 18 to 23, 23 to 28, 28 to 33, 33 to 38, 38 to 43, 43 to 48

    Registry description

    Recording of autonomic activity beginning prior to study drug administration (-40 minutes) until the end of recovery from the TSST (+38 minutes). Mobile Impedance Cardiographs (MindWare Tech Ltd, Gahanna, OH) was used to measure cardiac rate and interbeat interval (IBI). MindWare Heart Rate Variability (HRV) software was used to derive respiration and to calculate high frequency respiratory sinus arrhythmia power from the IBI series as an index of parasympathetic activity. Results are reported as difference from the mean of high frequency respiratory sinus arrhythmia power measured in the first ten minutes of the study visit, prior to administration of OT or placebo.

  4. Changes in Pre-ejection Period, an Index of Sympathetic Activity, During the TSST

    Time frame · Minutes -40 to -35, -35 to -30, -30 to -25, -25 to -20, -20 to -15, -15 to -10, -10 to -5, -5 to 0, 5 to 8, 8 to 13, 13 to 18, 18 to 23, 23 to 28, 28 to 33, 33 to 38, 38 to 43, 43 to 48

    Registry description

    Recording of autonomic activity beginning prior to study drug administration (-40 minutes) until the end of recovery from the TSST (+38 minutes). Mobile Impedance Cardiographs (MindWare Tech Ltd, Gahanna, OH) will be used to measure pre-ejection period (PEP). PEP will index sympathetic activation. Results are reported as difference from the mean of pre-ejection period measured in the first ten minutes of the study visit, prior to administration of OT or placebo.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· -40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutes

Mean Cortisol (CRT) During Trier Social Stress Test (TSST)

GroupValue (pg/mL)Spread
Intranasal Oxytocin19.1713.46
Placebo16.8710.84
Secondary and other outcome results(7)
Secondary outcomeMean· -40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutes

Mean Adrenocorticotropic Hormone (ACTH ) During TSST

GroupValue (pg/mL)Spread
Intranasal Oxytocin79.9664.89
Placebo86.77103.00
Secondary outcomeNumber· ACTH at -40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes and Cortisol at -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutes

Lagged Association Between ACTH and CRT During the TSST

GroupValue (Correlation coefficient)
Intranasal Oxytocin0.07
Placebo0.44
Secondary outcomeMean· Minutes -40 to -35, -35 to -30, -30 to -25, -25 to -20, -20 to -15, -15 to -10, -10 to -5, -5 to 0, 5 to 8, 8 to 13, 13 to 18, 18 to 23, 23 to 28, 28 to 33, 33 to 38, 38 to 43, 43 to 48

Changes in High Frequency Respiratory Sinus Arrhythmia Power, an Index of Parasympathetic Activity, During the TSST

GroupValue (ms squared)Spread
Intranasal Oxytocin9.4867367.6
Placebo25.2298426.2
Secondary outcomeMean· Minutes -40 to -35, -35 to -30, -30 to -25, -25 to -20, -20 to -15, -15 to -10, -10 to -5, -5 to 0, 5 to 8, 8 to 13, 13 to 18, 18 to 23, 23 to 28, 28 to 33, 33 to 38, 38 to 43, 43 to 48

Changes in Pre-ejection Period, an Index of Sympathetic Activity, During the TSST

GroupValue (milliseconds)Spread
Intranasal Oxytocin-0.01335.0895
Placebo-0.53445.2068
Other pre specified outcome· -40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutes

Assessment of Effect Modification by Maternal Depression / Anxiety on Changes in Cortisol (CRT) During Trier Social Stress Test (TSST)

GroupValue
Other pre specified outcome· -40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutes

Assessment of Effect Modification by Maternal Depression / Anxiety on Changes in Adrenocorticotropic Hormone (ACTH ) During TSST

GroupValue
Other pre specified outcome· Minutes -40 to -35, -35 to -30, -30 to -25, -25 to -20, -20 to -15, -15 to -10, -10 to -5, -5 to 0, 0 to 5, 5 to 8, 8 to 13, 13 to 18, 18 to 23, 23 to 28, 28 to 33, 33 to 38, 38 to 43, 43 to 48

Assessment of Effect Modification by Maternal Depression / Anxiety on Changes in High Frequency Heart Rate Variability, an Index of Parasympathetic Activity, During the TSST

GroupValue

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Intranasal OxytocinParticipants block randomized to Oxytocin intranasal spray by risk status at enrollment in the Mood, Mother and Infant (MMI) study and as verified by structured clinical diagnostic interview (no history of depression or anxiety, past depression or anxiety, current depression or anxiety). Intranasal Oxytocin: Six intranasal sprays of oxytocin. Each insufflation delivers 4 IUs of oxytocin for a total oxytocin dosage of 24 IUs.0 / 510 / 510 / 51
PlaceboParticipants block randomized to placebo Intranasal spray with all equivalent ingredients except oxytocin. Blocks will be stratified by risk status at enrollment in the Mood, Mother and Infant (MMI) study and as verified by structured clinical diagnostic interview (no history of depression or anxiety, past depression or anxiety, current depression or anxiety). Placebo: Six intranasal sprays of placebo manufactured to mimic oxytocin nasal spray containing all equivalent ingredients except oxytocin.0 / 540 / 541 / 54

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2023

The Mood, Mother and Child Study: Protocol for a Prospective Longitudinal Study and Randomized Controlled Trial.

Mills-Koonce et al. 2023JMIR research protocols

PMID 37883133PMC10636628DOI 10.2196/51132PUB-37883133

CC BY
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Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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: 1. Singleton pregnancy; 2. Intention to breastfeed (due to the centrality of breastfeeding to the oxytocin assessment); 3. Intention to remain within 40 miles of the University of North Carolina - Chapel Hill through infant's first birthday; 4. Ability to communicate in English. Exclusion Criteria: 1. 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. 2. Active substance abuse at enrollment in the 3rd trimester of pregnancy (Tobacco, alcohol, illicit substances); 3. Major congenital anomaly; 4. Chronic medication/medical condition contraindicated for breastfeeding; 5. 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.

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