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The objective of this study is to test a single dose of intranasal oxytocin, compared to placebo, in a within subjects, crossover design, to see if oxytocin will improve satiety signaling (behaviorally and/or by self report) compared to placebo. If this single dose pilot paradigm shows an increase in satiety, it may be tested in follow-up studies as a prevention or treatment for weight gain and overeating in people with schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin/Placebo | Active Comparator | Each participant will receive intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects. |
|
| Placebo/Oxytocin | Active Comparator | Each participant will receive intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | Single dose intranasal oxytocin (24 IU) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Food Consumption After Intervention | We hypothesize that participants will have greater satiety signaling, indicated by less consumption of the "Test Meal" consumed 90 minutes after the preload. | 90 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly Warren, PhD | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maryland Psychiatric Research Center | Catonsville | Maryland | 21716 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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17 participants were randomized, 16 participants participated in the trial. All data is available for only 16 participants
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxytocin/ Placebo | Each participant will receive intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxytocin vs Placebo | Participants rated themselves as significantly less hungry when administered OT (M=36.37, SD=21.0) than placebo (M=44.81, SD=28.6) at 60 min. post-preload, F(5, 15)=8.05, p=0.012. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Food Consumption After Intervention | We hypothesize that participants will have greater satiety signaling, indicated by less consumption of the "Test Meal" consumed 90 minutes after the preload. | Posted | Mean | Standard Deviation | Grams | 90 minutes |
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Adverse events were collected over a period of about 4 weeks (on each of the visit days)
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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 | Oxytocin | Each participant will receive intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Loss of Appetite | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kimberly R. Warren, Ph.D. | Morgan State University | 443-885-3492 | kimberly.warren@gmail.com |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic 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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All participants will receive both active drug and placebo, differences between treatment conditions will be analyzed due to small sample order effects will not be analyzed
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| Placebo |
| Drug |
Placebo- Sugar pill |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 2 |
| 16 |
| EG001 | Placebo | Each participant will receive intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects. | 0 | 16 | 0 | 16 | 4 | 16 |
| Bruisng Easily | General disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Dizziness | General disorders | Systematic Assessment |
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| Enuresis | General disorders | Systematic Assessment |
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| Malise | General disorders | Systematic Assessment |
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| Hyersalavation | General disorders | Systematic Assessment |
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| Sedation | General disorders | Systematic Assessment |
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| Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |