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Oxytocin for Schizophrenia (OT Trial)

Phase < 1
Waitlist Available
Led By Joshua D Woolley, MD/PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-days at least 1-week apart
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions

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.

Eligible Conditions
  • Schizophrenia
  • Oxytocin
  • Social Cognition

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-days at least 1-week apart
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-days at least 1-week apart for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Improvement in social cognition task performance
Secondary study objectives
Change in Auditory Perception correctness
Change in Auditory Perception reaction time
Change in Working Memory capacity
+5 more

Side effects data

From 2023 Phase 4 trial • 108 Patients • NCT04028765
6%
Blood transfusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Misoprostol-Mothers
Oxytocin-Mothers
Oral Misoprostol-Fetus/Neonate
Oxytocin-Fetus/Neonate

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OxytocinExperimental Treatment1 Intervention
40 IU Oxytocin
Group II: Saline Nasal SprayPlacebo Group1 Intervention
Placebo Comparator
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxytocin
FDA approved

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,587 Previous Clinical Trials
14,901,056 Total Patients Enrolled
17 Trials studying Schizophrenia
1,776 Patients Enrolled for Schizophrenia
San Francisco Veterans Affairs Medical CenterFED
51 Previous Clinical Trials
211,139 Total Patients Enrolled
3 Trials studying Schizophrenia
585 Patients Enrolled for Schizophrenia
Joshua D Woolley, MD/PhDPrincipal InvestigatorUniversity of California San Francisco, San Francisco Veterans Affairs Medical Center
~8 spots leftby Nov 2025