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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 belowSelect...
I have been diagnosed with a schizophrenia spectrum disorder.
Select...
I am between 18 and 70 years old.
Timeline
Screening ~ 3 weeks3 visits
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
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
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)
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
1,609 Previous Clinical Trials
3,306,577 Total Patients Enrolled
44 Trials studying Schizophrenia
5,138 Patients Enrolled for Schizophrenia
University of California, San FranciscoOTHER
2,503 Previous Clinical Trials
15,236,629 Total Patients Enrolled
17 Trials studying Schizophrenia
1,870 Patients Enrolled for Schizophrenia
VA Greater Los Angeles Healthcare SystemFED
51 Previous Clinical Trials
8,543 Total Patients Enrolled
7 Trials studying Schizophrenia
314 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently in a program to help with my social skills.I have had extensive dental work done.You have a fear of enclosed spaces.You have recently struggled with addiction to drugs or alcohol, except for mild or moderate addiction to cannabis.I have a condition affecting my nasal passages.I have a serious brain or nerve condition.I have been diagnosed with a schizophrenia spectrum disorder.You have a pacemaker.I am currently on high doses of testosterone or estrogen/progesterone.I am deaf.I cannot complete the voice test.The study is only open to military veterans.I am between 18 and 70 years old.I haven't changed my medications or been hospitalized for psychiatric reasons in the last month.
Research Study Groups:
This trial has the following groups:- Group 1: Intranasal Oxytocin
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What risks have been identified with Oxytocin use?
"Despite the fact that Oxytocin has not yet been proven to be efficacious, our team at Power has still assigned it a safety rating of 2 due to the existing clinical data."
Answered by AI
Is the trial currently accepting participants?
"According to information posted on clinicaltrials.gov, this trial is actively seeking participants since its initial posting in January 2020 and last edit in January 2022."
Answered by AI
How many individuals are currently taking part in the experiment?
"Indeed, the data on clinicaltrials.gov states that enrollment for this medical trial is currently ongoing. The study was first uploaded in January 2020 and its information has been most recently updated in January 2022; 188 individuals need to be recruited from two distinct locations."
Answered by AI
What medical conditions is Oxytocin typically utilized to alleviate?
"Oxytocin has been prescribed to manage intrapartum hemorrhage, labor induction, and uterine contractions."
Answered by AI
Does this trial accept participants aged 20 or older?
"Patients between the age of 18 and 70 are eligible to enrol in this trial. Additionally, there are 55 clinical trials for minors and 195 studies specifically designed for those over 65 years old."
Answered by AI
Who qualifies to partake in this medical research program?
"A total of 188 individuals suffering from schizophrenia, aged between 18 and 70 will be eligible to join this medical trial."
Answered by AI
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