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Adult Oxytocin Study

NCT02577575 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-05-21

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Oxytocin

40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.

DRUG

Saline Nasal Spray

40 IU of the saline nasal spray will be administered once at the beginning of the visit.

Sponsors & Collaborators

Principal Investigators

  • Joshua D Woolley, MD/PhD · University of California San Francisco, San Francisco Veterans Affairs Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02577575 on ClinicalTrials.gov