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| Name | Class |
|---|---|
| San Francisco Veterans Affairs Medical Center | FED |
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In this study, investigators will examine the behavioral effects and neurophysiological mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset schizophrenia and other psychotic disorders. Such research is a necessary first step towards identifying whether intranasal oxytocin administration can serve as an adjunct treatment for social impairments in schizophrenia and other psychotic disorders.
Aim 1: To quantify the effects of exogenous oxytocin on social cognition and behavior in patients with recent-onset schizophrenia.
Hypothesis A: Patients and healthy comparison subjects will show enhanced social cognition (e.g., improved interpretation of paralinguistic and emotional cues, such as those involved in emotional or sarcastic communication) after administration of oxytocin versus placebo.
Hypothesis B: Patients and healthy comparison subjects will show increased attention to others' eyes and patients will exhibit increased facial affect expressivity after administration of oxytocin versus placebo.
Part 2: A supplementary study will be added to the proposed parent study, which includes additional behavioral testing consisting of several social cognition computer tasks, clinical assessments, physiological measurements, and questionnaires. The study will be conducted with the same study arms and study interventions as in the proposed parent study. For this supplementary study, the inclusion criteria has broadened to include patients with bipolar disorder with psychotic features and brief psychotic disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin | Experimental | 40 IU Oxytocin |
|
| Saline Nasal Spray | Placebo Comparator | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | 40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Social Cognition Task Performance | Participants will undergo computer tasks that measure social cognition. Tasks will involve verbal responses, pressing buttons at specific times, listening, and viewing audio-visual stimuli. Investigators will be measuring the difference in accuracy and verbal content of the responses on the oxytocin day compared to the placebo day. | Through study completion, 2-3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Physiological Measurements | Sensors will be attached to measure heart rate, respiration, and skin conductance during computer tasks. | Through study completion, 2-3 weeks |
| Questionnaire | Participants will be asked questions about their current positive and negative symptoms, medical and psychiatric history. Self-report responses will be saved in writing or audio recording. |
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Inclusion Criteria for Patients:
Inclusion Criteria for healthy volunteers:
Exclusion Criteria for Patients:
Exclusion Criteria for Healthy Controls:
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| Name | Affiliation | Role |
|---|---|---|
| Josh D Woolley, MD/PhD | University of California San Francisco, San Francisco Veterans Affairs Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco Veterans Affairs Medical Center | San Francisco | California | 94121 | United States | ||
| University of California, San Francisco |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| 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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| Saline Nasal Spray | Drug | 40 IU of the saline nasal spray will be administered once at the beginning of the visit. |
|
|
| At baseline visit, up to 4 hours |
| San Francisco |
| California |
| 94143 |
| United States |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |