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Neuropeptide

Oxytocin Treatment of Schizophrenia (OTS Trial)

N/A
Waitlist Available
Led By Cort A Pedersen, M.D.
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions

Summary

Purpose: Test whether intranasal administration of the neuropeptide, oxytocin, improves social cognition, social functioning and decreases paranoia and other psychotic symptoms in schizophrenia. Participants: Up to 80 adults with schizophrenia for at least one year and with a high rating for paranoia. Procedures (methods): Oxytocin or placebo will be administered twice daily in an intranasal spray (6 insufflations/dose or 24 IU) for 6 weeks. Before, during and at the end of the trial, each subject will undergo social cognitive measures (primary outcomes) and psychiatric symptom ratings (secondary outcomes).

Eligible Conditions
  • Schizophrenia
  • Paranoia
  • Schizoaffective Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point
Empathy as Measured by the Interpersonal Reactivity Index (IRI) at 6 Weeks
Social Perception as Measured by the Trustworthiness Task at 6 Weeks
+2 more
Secondary study objectives
Clinical Psychiatric Symptoms as Measured by Positive and Negative Syndrome Scale (PANSS) at 6 Weeks

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: intranasal spray with oxytocinExperimental Treatment1 Intervention
Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks
Group II: intranasal spray without oxytocinPlacebo Group1 Intervention
Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.
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 North Carolina, Chapel HillLead Sponsor
1,569 Previous Clinical Trials
4,319,690 Total Patients Enrolled
26 Trials studying Schizophrenia
2,638 Patients Enrolled for Schizophrenia
Cort A Pedersen, M.D.Principal InvestigatorUniversity of North Carolina, Chapel Hill
1 Previous Clinical Trials
14 Total Patients Enrolled
~1 spots leftby Jan 2026
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