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Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency

ConditionVasopressin Deficiency
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorElizabeth Austen Lawson

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 and above

Arginine-vasopressin deficiency

Normal FT4 or T4

Normal serum/plasma sodium

Disqualifiers

Active substance use disorder within the last 6 months

History of psychosis

Suicidal behavior and/or active suicidal ideation with plan and/or intent, e.g., suicidal ideation of type 4 or type 5 as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS), in the last month

Medication changes within 4 weeks of enrollment or planned medication changes during the study

Trial design

Design model

Crossover

Treatments tested in this trial

  • Intranasal Oxytocin (IN-OXT)

    Drug

    6 IU single dose

  • Intranasal Oxytocin (IN-OXT)

    Drug

    IN-OXT 6 IU three times a day for 2 weeks

  • Placebo

    Drug

    Intranasal placebo three times a day for 2 weeks

  • Intranasal Oxytocin (IN-OXT)

    Drug

    24 IU single dose

  • Placebo

    Drug

    placebo single dose

Treatment groups

40 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Part A Arm 1Experimental treatment 2 interventions
Group B: Part A Arm 2Experimental treatment 2 interventions
Group C: Part A Arm 3Experimental treatment 2 interventions
Group D: Part A Arm 4Experimental treatment 2 interventions
Group E: Part A Arm 5Experimental treatment 2 interventions
Group F: Part A Arm 6Experimental treatment 2 interventions
Group G: Part B Arm 1Active comparator 1 intervention
Group H: Part B Arm 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dot-probe task - anxious behavior between low dose oxytocin and placebo

Difference in response times (in milliseconds) to dots appearing in the location of the previously shown negative versus the neutral face between 6 IU oxytocin vs placebo in the dot-probe task.

Time frame
20 minutes following intervention at each main visit

Secondary outcomes

1

Dot-probe task - anxious behavior between all three interventions

Difference in response time (in milliseconds) to dots appearing in the location of the previously shown negative versus neutral face between 6 IU oxytocin, 24 IU oxytocin, and placebo in the dot-probe task.

Time frame
20 minutes following intervention
2

Depressive behavior - probabilistic reward task between all three interventions

Response bias developed toward the more frequently reinforced alternative between 6 IU oxytocin, 24 IU oxytocin, and placebo in the probabilistic reward task.

Time frame
30 minutes following intervention at each main visit
3

Socioemotional functioning - Emotion recognition task between all three interventions

Accuracy in identifying correct emotion between 6 IU oxytocin, 24 IU oxytocin, and placebo in the emotion recognition task.

Time frame
40 minutes following intervention at each main visit

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Elizabeth Austen Lawson

Lead sponsor

Massachusetts General Hospital

Sponsor institution

Tonix Pharmaceuticals, Inc.

Collaborator

Source ClinicalTrials.gov
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