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NCT03593473 · ClinicalTrials.gov registry record · Phase 2
Inhaled Oxytocin and HPA Axis Reactivity
A Phase 2 study of Anxiety Disorders and Stress, Psychological, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 109
- Enrollment target
- 1
- Study location
NCT03593473: Completed Phase 2 study of Anxiety Disorders and Stress, Psychological, sponsored by University of North Carolina, Chapel Hill.
NCT03593473 is a Phase 2 study of Anxiety Disorders and Stress, Psychological that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 109 participants, below the 1,139-participant average among 84 other Anxiety Disorders trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03593473, a Phase 2 study of Anxiety Disorders and Stress, Psychological, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 109 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Intranasal Oxytocin
Study Locations (1)
North Carolina
- University of North Carolina School of Medicine - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2019-02-07 |
| Est. Completion | 2023-07-25 |
| Phase | Phase 2 |
What the finished NCT03593473 record still lists
NCT03593473 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 1,139-participant average among 84 other Anxiety Disorders trials with a reported enrollment target (90% lower).
The record links to 3 conditions, with Anxiety Disorders appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03593473 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03593473 about?
NCT03593473 is a clinical study titled "Inhaled Oxytocin and HPA Axis Reactivity". 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 par...
What is the current status of trial NCT03593473?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 109 participants. The study started on 2019-02-07. Estimated completion is 2023-07-25.
What conditions does trial NCT03593473 study?
This clinical trial studies the following conditions: Anxiety Disorders, Stress, Psychological, Depression, Postpartum.
What interventions are being tested in trial NCT03593473?
The interventions under investigation include: Placebo (DRUG), Intranasal Oxytocin (DRUG).
Who is sponsoring clinical trial NCT03593473?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03593473 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Anxiety Disorders
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03593473's enrollment target sits among peer trials
109 43rd of 84 higher than 42 of 84 other Anxiety Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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