Oxytocin
Drug40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
Other names: Syntocinon
NCT Number: NCT02567032
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.
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Notify Me18 year–45 year
Male
Interventional
Early Phase 1
San Francisco Veterans Affairs Medical Center, San Francisco, California, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Patients:
Inclusion criteria
for healthy volunteers:
Exclusion criteria
for Patients:
Exclusion criteria
for Healthy Controls:
40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
Other names: Syntocinon
40 IU of the saline nasal spray will be administered once at the beginning of the visit.
Other names: Placebo
Time frame: Through study completion, 2-3 weeks
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.
Time frame: Through study completion, 2-3 weeks
Sensors will be attached to measure heart rate, respiration, and skin conductance during computer tasks.
Time frame: At baseline visit, up to 4 hours
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.
University of California, San Francisco
Other
Mechanisms and Effects of Oxytocin on Social Cognition in Schizophrenia - Behavioral
Acronym: ASO-Behavioral
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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