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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The purpose of the study is to learn how differences in learning under mildly-stressful circumstances may be changed by taking oxytocin. Oxytocin is a hormone made naturally in the body. The investigators will also examine the impact of any anxiety, depression, and stress related symptoms on learning processes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matched nasal spray placebo. |
|
| Oxytocin | Experimental | Liquid intranasal oxytocin administered in a nasal spray. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | Liquid metered-dose nasal spray, 30 IUs, administered once. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Differential Skin Conductance Response (SCR) During the First Two Extinction Trials | Differences in skin conductance response (SCR) between the active vs. placebo conditions trials will be used to assess for the impact of oxytocin on fear acquisition and extinction. We will take a mean of the first two extinction trials to get this measure. Data was gathered in micro-Siemens and then underwent a square root transformation. | Day 2 of Conditioning (1 day post Day 1 of Conditioning) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth A Hoge, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Anxiety and Traumatic Disorders, MGH | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matched nasal spray placebo. Placebo: Matched nasal spray placebo |
| FG001 | Oxytocin | Liquid intranasal oxytocin administered in a nasal spray. Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Although 60 participants were enrolled, only 30 participants had usable physiological data from recording electrodes, and therefore, the only data analyzed were from these 30 participants (16 placebo and 14 oxytocin).
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matched nasal spray placebo. Placebo: Matched nasal spray placebo |
| BG001 | Oxytocin | Liquid intranasal oxytocin administered in a nasal spray. Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Differential Skin Conductance Response (SCR) During the First Two Extinction Trials | Differences in skin conductance response (SCR) between the active vs. placebo conditions trials will be used to assess for the impact of oxytocin on fear acquisition and extinction. We will take a mean of the first two extinction trials to get this measure. Data was gathered in micro-Siemens and then underwent a square root transformation. | Posted | Mean | Standard Deviation | micro-Siemens (square rooted) | Day 2 of Conditioning (1 day post Day 1 of Conditioning) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Matched nasal spray placebo. Placebo: Matched nasal spray placebo |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bloody Nose | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Hoge, M.D. | Massachusetts General Hospital | 617-724-0859 | ehoge@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Placebo | Drug | Matched nasal spray placebo |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 0 |
| 16 |
| 1 |
| 16 |
| EG001 | Oxytocin | Liquid intranasal oxytocin administered in a nasal spray. Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once. | 0 | 14 | 0 | 14 |
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |