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Peptide

Oxytocin for Schizophrenia

Phase 2
Waitlist Available
Led By Josh Woolley, BS
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
a diagnosis of schizophrenia, schizophreniform, schizoaffective, or brief psychotic disorder determined by the Structured Clinical Interview for DSM-5
age 18-70
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the baseline visit in the chronic ot administration portion of the study design to after three weeks of oxytocin administration
Awards & highlights

Study Summary

This trial will test whether oxytocin can help improve social functioning in veterans with schizophrenia, which is often poor due to the disabling symptoms of the disease.

Who is the study for?
This trial is for veterans aged 18-70 with schizophrenia or related disorders, who haven't had medication changes or hospitalizations in the past month. They must have a certain level of social functioning difficulty and not be undergoing specific psychosocial interventions. Exclusions include hearing impairments, metal implants that affect MRI safety, severe claustrophobia, recent substance abuse (except some cannabis), nasal passage issues, and significant neurological conditions.Check my eligibility
What is being tested?
The study tests if Oxytocin can improve social functioning in schizophrenia by comparing it to a placebo. Researchers will use brain imaging to see how Oxytocin affects behavior and identify who might benefit from this treatment.See study design
What are the potential side effects?
Oxytocin may cause side effects like irritation at the injection site, headaches, nausea, changes in heart rate or blood pressure. However, since it's naturally occurring in the body, many people tolerate it well.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a schizophrenia spectrum disorder.
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I am between 18 and 70 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the baseline visit in the chronic ot administration portion of the study design to after three weeks of oxytocin administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the baseline visit in the chronic ot administration portion of the study design to after three weeks of oxytocin administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Social Functioning Score
Secondary outcome measures
CAINS Score (clinical assessment interview for negative symptoms)
Other outcome measures
Hinting Task
QLS Scale (quality of life)

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-Fetus/Neonate
Oral Misoprostol-Fetus/Neonate
Oxytocin-Mothers

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intranasal OxytocinExperimental Treatment1 Intervention
Dosages of oxytocin: 20IU or 40IU.
Group II: PlaceboPlacebo Group1 Intervention
Saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxytocin
2016
Completed Phase 4
~2340

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,620 Previous Clinical Trials
3,323,380 Total Patients Enrolled
44 Trials studying Schizophrenia
5,138 Patients Enrolled for Schizophrenia
University of California, San FranciscoOTHER
2,518 Previous Clinical Trials
15,241,703 Total Patients Enrolled
17 Trials studying Schizophrenia
1,870 Patients Enrolled for Schizophrenia
VA Greater Los Angeles Healthcare SystemFED
51 Previous Clinical Trials
8,541 Total Patients Enrolled
7 Trials studying Schizophrenia
314 Patients Enrolled for Schizophrenia

Media Library

Oxytocin (Peptide) Clinical Trial Eligibility Overview. Trial Name: NCT03900754 — Phase 2
Schizophrenia Research Study Groups: Intranasal Oxytocin, Placebo
Schizophrenia Clinical Trial 2023: Oxytocin Highlights & Side Effects. Trial Name: NCT03900754 — Phase 2
Oxytocin (Peptide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03900754 — Phase 2
~5 spots leftby Jun 2025
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