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| Name | Class |
|---|---|
| Tonix Pharmaceuticals, Inc. | INDUSTRY |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Arm 1 | Experimental | Main visit 1: 6 IU intranasal oxytocin; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: intranasal placebo |
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| Part A Arm 2 | Experimental | Main visit 1: 6 IU intranasal oxytocin; Main visit 2: intranasal placebo; Main visit 3: 24 IU intranasal oxytocin |
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| Part A Arm 3 | Experimental | Main visit 1: 24 IU intranasal oxytocin; Main visit 2: 6 IU intranasal oxytocin; Main visit 3: intranasal placebo |
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| Part A Arm 4 | Experimental | Main visit 1: 24 IU intranasal oxytocin; Main visit 2: intranasal placebo; Main visit 3: 6 IU intranasal oxytocin |
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| Part A Arm 5 | Experimental | Main visit 1: intranasal placebo; Main visit 2: 6 IU intranasal oxytocin; Main visit 3: 24 IU intranasal oxytocin |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal Oxytocin (IN-OXT) | Drug | 6 IU single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 20 minutes following intervention at each main visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 20 minutes following intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesca Galbiati, MD | Contact | (617) 726-3870 | FGALBIATI@BWH.HARVARD.EDU | |
| Elisa Asanza, MSN, MPH | Contact | 617-726-3870 | easanza@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth A Lawson, MD, MMSc | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital, Neuroendocrine Unit | Recruiting | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D020790 | Diabetes Insipidus, Neurogenic |
| D007018 | Hypopituitarism |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003919 | Diabetes Insipidus |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Randomized, double-blind, placebo-controlled, single dose crossover study evaluating 2 different dose levels of intranasal oxytocin vs placebo (Part A), followed by Part B, an optional 2-week randomized, double-blind, placebo-controlled substudy investigating intranasal oxytocin 6 IU vs. placebo three times a day.
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| Part A Arm 6 | Experimental | Main visit 1: intranasal placebo; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: 6 IU intranasal oxytocin |
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| Part B Arm 1 | Active Comparator | Intranasal oxytocin 6 IU three times a day for 14 days |
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| Part B Arm 2 | Experimental | Intranasal placebo three times a day for 14 days |
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| Intranasal Oxytocin (IN-OXT) | Drug | IN-OXT 6 IU three times a day for 2 weeks |
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| Placebo | Drug | Intranasal placebo three times a day for 2 weeks |
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| Intranasal Oxytocin (IN-OXT) | Drug | 24 IU single dose |
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| Placebo | Drug | placebo single dose |
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| 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. |
| 30 minutes following intervention at each main visit |
| 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. | 40 minutes following intervention at each main visit |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |