Adult Oxytocin Study
Completed · Early Phase 1 · Has a placebo group
Conditions studied: Schizophrenia, Oxytocin, Social Cognition
In brief
In this study, investigators will examine the behavioral effects and neurophysiological mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset schizophrenia. Such research is a necessary first step towards identifying whether intranasal oxytocin administration can serve as an adjunct treatment for social impairments in schizophrenia. 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. Aim 2: To examine the effects of exogenous oxytocin on persistent negative symptoms in schizophrenia (PNS) activity in patients with recent-onset schizophrenia. Hypothesis A: Patients and healthy comparison subjects will demonstrate increased PNS activity during social tasks after administration of oxytocin versus placebo. Hypothesis B (exploratory): Patients and healthy comparison subjects' improvements in social cognition and behavior will be predicted by the degree to which oxytocin increases their PNS activity.
Key facts
- Study ID
- NCT02577575
- Run by
- University of California, San Francisco
- People needed
- 120
- Starts
- 2010-08-01
- Expected to finish
- 2015-11-01
- Last updated by the study team
- 2019-05-21
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Active substance abuse or dependence as determined by a Urine Toxicology Drug Screening
- A current DSM-IV diagnosis of any disorder other than schizophrenia
- Medical conditions (atrophic rhinitis, recurrent nose bleeds and cranial-surgical procedures (hypophysectomy), congestion or sinus problems) that could interfere with the study as per the opinion of the investigator
- Hearing deficits
- Pregnancy
- Severe brain trauma
Where it is running
- San Francisco Veterans Affairs Medical Center — San Francisco, California, United States
- University of California, San Francisco — San Francisco, California, United States
Full record on ClinicalTrials.gov
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