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Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Jun 2026 → Jun 2027
See other at-risk trials from Elizabeth Austen Lawson

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Jun 2026 to Jun 2027v10
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 2025 to Sep 10, 2025
    • Site details revised
    v9
  3. Primary and study completion dates: Jun 30, 2025 to Jun 2026v8 Show 9 more changesShow less
    • Start date: Jun 2023 to Jul 2025
    • Enrollment target: 30 to 40
    • Interventions: Oxytocin nasal spray (Drug) to Intranasal Oxytocin (IN-OXT) (Drug), Intranasal Oxytocin (IN-OXT) (Drug), Intranasal Oxytocin (IN-OXT) (Drug), Placebo (Drug), Placebo…
    • Secondary endpoints: details revised at 3 of 3 entries
    • Site contact updated
    • Study arms: 6 to 8
    • Eligibility criteria expanded, about 1 word
    • Collaborators expanded, about 3 words
    • Study title shortened, about 1 word
  4. Primary and study completion dates: Mar 31, 2023 to Jun 30, 2025
    • Start date: Aug 2022 to Jun 2023
    v7
  5. Start date: Feb 2022 to Aug 2022v6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: Nov 1, 2021 to Feb 2022v5
  2. Start date: Aug 1, 2021 to Nov 1, 2021
    • Trial status: Recruiting to Not Yet Recruiting
    • Site details revised
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 1, 2021 to Aug 1, 2021
    • Site details revised
    v3
  4. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a randomized, double-blind, placebo-controlled crossover pilot study of single-dose intranasal oxytocin (6 IU and 24 IU) vs. placebo in adult men and women (aged 18 years and above) with arginine-vasopressin deficiency to evaluate the effect of oxytocin on anxiety, depression, and socioemotional functioning (Part A), with an optional randomized, double-blind, placebo-controlled 2-week repeated dose substudy of intranasal oxytocin 6 IU or placebo (Part B). Following a screening visit to determine eligibility, participants will return for three main study visits in Part A. During the main study visits, study participants will receive either oxytocin or placebo, followed by assessments of emotional behavior. In Part A, thirty participants will be equally randomized to one of six possible groups: 1. 6 IU oxytocin - 24 IU oxytocin - placebo 2. 6 IU oxytocin - placebo - 24 IU oxytocin 3. 24 IU oxytocin - 6 IU oxytocin - placebo 4. 24 IU oxytocin - placebo - 6 IU oxytocin 5. placebo - 6 IU oxytocin - 24 IU oxytocin 6. placebo - 24 IU oxytocin - 6 IU oxytocin Following completion of the Part A crossover portion of the study, in Part B participants may also choose to continue participation in an optional, randomized, double-blind, placebo-controlled substudy of intranasal oxytocin 6 IU or placebo three times a day for two weeks, followed by assessments of emotional behavior.
Trial Details
NCT Number NCT04789148
Lead Sponsor Elizabeth Austen Lawson
Collaborators: Tonix Pharmaceuticals, Inc.
Conditions
(from sponsor)		 Vasopressin Deficiency
Related terms Anxiety Disorders, Depression, Diabetes Insipidus, Neurogenic, Hypopituitarism
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov