Trial · NCT03593473
Inhaled Oxytocin and HPA Axis Reactivity
NCT03593473, Phase 2, Completed, University of North Carolina, Chapel Hill; results first posted 2024-05-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Inhaled Oxytocin and HPA Axis Reactivity. Trials, record NCT03593473. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03593473
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Inhaled Oxytocin and HPA Axis Reactivity
- NCT number
- NCT03593473
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 109 participants, actual
- Lead sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Depression, Postpartum, Anxiety Disorders, Stress, Psychological
- Interventions
- Intranasal Oxytocin, Placebo
- First posted
- 2018-07-20
- Last updated
- 2025-08-08
- Results first posted
- 2024-05-24
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Cortisol (CRT) During Trier Social Stress Test (TSST) | -40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutes | 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 | Mean Adrenocorticotropic Hormone (ACTH ) During TSST | -40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutes | 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). |
| Secondary | Lagged Association Between ACTH and CRT During the TSST | 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 | 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). |
| Secondary | Changes in High Frequency Respiratory Sinus Arrhythmia Power, an Index of Parasympathetic Activity, During the TSST | 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 | 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. |
| Secondary | Changes in Pre-ejection Period, an Index of Sympathetic Activity, During the TSST | 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 | 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. |
| Other | Assessment of Effect Modification by Maternal Depression / Anxiety on Changes in Cortisol (CRT) During Trier Social Stress Test (TSST) | -40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutes | Stratified analyses will be performed to determine the extent to which maternal depression/anxiety modifies the effect of OT/placebo on CRT during the TSST. |
| Other | Assessment of Effect Modification by Maternal Depression / Anxiety on Changes in Adrenocorticotropic Hormone (ACTH ) During TSST | -40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutes | Stratified analyses will be performed to determine the extent to which maternal depression/anxiety modifies the effect of OT/placebo on ACTH during the TSST. |
| Other | Assessment of Effect Modification by Maternal Depression / Anxiety on Changes in High Frequency Heart Rate Variability, an Index of Parasympathetic Activity, During the TSST | 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 | Stratified analyses will be performed to determine the extent to which maternal depression/anxiety modifies the effect of OT/placebo on parasympathetic activity during the TSST. |
| Other | Assessment of Effect Modification by Maternal Depression / Anxiety on Changes in Pre-ejection Period, an Index of Sympathetic Activity, During the TSST | 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 | Stratified analyses will be performed to determine the extent to which maternal depression/anxiety modifies the effect of OT/placebo on sympathetic activity during the TSST. |
| Other | Assessment of Effect Modification by Oxytocin Receptor (OXTR) Genotype on Changes in Cortisol (CRT) During Trier Social Stress Test (TSST) | -40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutes | Stratified analyses will be performed to determine the extent to which maternal depression/anxiety modifies the effect of OT/placebo on CRT during the TSST. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Cortisol (CRT) During Trier Social Stress Test (TSST) | -40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutes | Samples were collected by IV. In some participants, an IV was not able to be placed and samples could not be collected. In some participants, an IV was successfully placed, but the IV infiltrated before the end of the observation period and not all timepoints were collected. One participant had a vasovagal episode when the IV was placed and samples were not collected. All collected data are reported herein. | pg/mL | MEAN |
| SECONDARY | Mean Adrenocorticotropic Hormone (ACTH ) During TSST | -40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutes | Samples were collected by IV. In some participants, an IV was not able to be placed and samples could not be collected. In some participants, an IV was successfully placed, but the IV infiltrated before the end of the observation period and not all timepoints were collected. One participant had a vasovagal episode when the IV was placed and samples were not collected. All collected data are reported herein. | pg/mL | MEAN |
| SECONDARY | Lagged Association Between ACTH and CRT During the TSST | 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 | Samples were collected by IV. In some participants, an IV was not able to be placed and samples could not be collected. In some participants, an IV was successfully placed, but the IV infiltrated before the end of the observation period and not all timepoints were collected. One participant had a vasovagal episode when the IV was placed and samples were not collected. All collected data are reported herein. | Correlation coefficient | NUMBER |
| SECONDARY | Changes in High Frequency Respiratory Sinus Arrhythmia Power, an Index of Parasympathetic Activity, During the TSST | 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 | For two participants in each arm, cardiograph recording was unsuccessful. For some time periods for some participants, data quality or quantity (in terms of lacking sufficient numbers of epochs within a period) was insufficient for analysis. All valid, analyzable data are reported herein. | ms squared | MEAN |
| SECONDARY | Changes in Pre-ejection Period, an Index of Sympathetic Activity, During the TSST | 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 | For some participants in each arm, cardiograph recording was unsuccessful. For some time periods for some participants, data quality or quantity (in terms of lacking sufficient numbers of epochs within a period) was insufficient for analysis. All valid, analyzable data are reported herein. | milliseconds | MEAN |
| OTHER_PRE_SPECIFIED | Assessment of Effect Modification by Maternal Depression / Anxiety on Changes in Cortisol (CRT) During Trier Social Stress Test (TSST) | -40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutes | |||
| OTHER_PRE_SPECIFIED | Assessment of Effect Modification by Maternal Depression / Anxiety on Changes in Adrenocorticotropic Hormone (ACTH ) During TSST | -40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutes | |||
| OTHER_PRE_SPECIFIED | Assessment of Effect Modification by Maternal Depression / Anxiety on Changes in High Frequency Heart Rate Variability, an Index of Parasympathetic Activity, During the TSST | 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 | |||
| OTHER_PRE_SPECIFIED | Assessment of Effect Modification by Maternal Depression / Anxiety on Changes in Pre-ejection Period, an Index of Sympathetic Activity, During the TSST | 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 | |||
| OTHER_PRE_SPECIFIED | Assessment of Effect Modification by Oxytocin Receptor (OXTR) Genotype on Changes in Cortisol (CRT) During Trier Social Stress Test (TSST) | -40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutes |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group114
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Cortisol (CRT) During Trier Social Stress Test (TSST) | Intranasal Oxytocin | -40 minutes | 19.17 | Standard Deviation 13.46 | pg/mL |
| Mean Cortisol (CRT) During Trier Social Stress Test (TSST) | Placebo | -40 minutes | 16.87 | Standard Deviation 10.84 | pg/mL |
| Mean Cortisol (CRT) During Trier Social Stress Test (TSST) | Intranasal Oxytocin | -20 minutes | 15.71 | Standard Deviation 10.16 | pg/mL |
| Mean Cortisol (CRT) During Trier Social Stress Test (TSST) | Placebo | -20 minutes | 13.89 | Standard Deviation 9.68 | pg/mL |
| Mean Cortisol (CRT) During Trier Social Stress Test (TSST) | Intranasal Oxytocin | 0 minutes | 14.06 | Standard Deviation 10.41 | pg/mL |
| Mean Cortisol (CRT) During Trier Social Stress Test (TSST) | Placebo | 0 minutes | 13.03 | Standard Deviation 8.99 | pg/mL |
| Mean Cortisol (CRT) During Trier Social Stress Test (TSST) | Intranasal Oxytocin | +10 minutes | 14.39 | Standard Deviation 10.55 | pg/mL |
| Mean Cortisol (CRT) During Trier Social Stress Test (TSST) | Placebo | +10 minutes | 13.60 | Standard Deviation 9.45 | pg/mL |
| Mean Cortisol (CRT) During Trier Social Stress Test (TSST) | Intranasal Oxytocin | +15 minutes | 15.27 | Standard Deviation 12.56 | pg/mL |
| Mean Cortisol (CRT) During Trier Social Stress Test (TSST) | Placebo | +15 minutes | 15.64 | Standard Deviation 10.16 | pg/mL |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intranasal Oxytocin | 53 | |
| Overall Study | STARTED | Placebo | 56 | |
| Overall Study | Randomized | Intranasal Oxytocin | 53 | |
| Overall Study | Randomized | Placebo | 56 | |
| Overall Study | Received Intervention | Intranasal Oxytocin | 51 | |
| Overall Study | Received Intervention | Placebo | 54 | |
| Overall Study | COMPLETED | Intranasal Oxytocin | 51 | |
| Overall Study | COMPLETED | Placebo | 54 | |
| Overall Study | NOT COMPLETED | Intranasal Oxytocin | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypotension | General disorders | Intranasal Oxytocin | 0 | 51 | 0 |
| other | Hypotension | General disorders | Placebo | 1 | 54 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intranasal Oxytocin | 0 | 51 |
| Total, all-cause mortality | Placebo | 0 | 54 |
| Total, other adverse events | Intranasal Oxytocin | 0 | 51 |
| Total, other adverse events | Placebo | 1 | 54 |
| Total, serious adverse events | Intranasal Oxytocin | 0 | 51 |
| Total, serious adverse events | Placebo | 0 | 54 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37883133 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HD093901 | Mood, mother, and child: The psychobiology of dyadic resilience | STUEBE, ALISON M; MILLS-KOONCE, WILLIAM ROGER | UNIV OF NORTH CAROLINA CHAPEL HILL | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2018 to 2022 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intranasal Oxytocin vs Placebo: deaths from any cause | Trial comparisons |
| Intranasal Oxytocin vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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