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Hormone Therapy

Oxytocin for Schizophrenia

Phase 4
Waitlist Available
Led By Stephen Marder, MD
Research Sponsored by University of California, Los Angeles
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 16 weeks
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will test whether oxytocin can help people learn social skills.

Who is the study for?
This trial is for stable individuals with schizophrenia or schizoaffective disorder who are consistently taking antipsychotic medication. It's not suitable for pregnant individuals or those with a history of head injury.
What is being tested?
The study tests if oxytocin nasal spray affects learning during social cognition training in schizophrenia patients, compared to a placebo spray. Health management techniques are also part of the program.
What are the potential side effects?
Oxytocin nasal spray may cause side effects like irritation in the nose, headache, and possible emotional changes due to its impact on social behavior.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 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
Social Cognition Composite Score
Secondary study objectives
Composite score of non-social cognition from the MATRICS Consensus Cognitive Battery

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.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Oxytocin with SCSTExperimental Treatment2 Interventions
Oxytocin with SCST (active condition)
Group II: Oxytocin with Health ManagementPlacebo Group2 Interventions
Administration of OT with control psychosocial treatment
Group III: Placebo with HMPlacebo Group2 Interventions
Administration of Placebo with control psychosocial treatment
Group IV: Placebo with SCSTPlacebo Group2 Interventions
Administration of Placebo with active psychosocial treatment
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?

National Institute of Mental Health (NIMH)NIH
2,893 Previous Clinical Trials
2,722,657 Total Patients Enrolled
253 Trials studying Schizophrenia
89,731 Patients Enrolled for Schizophrenia
University of California, Los AngelesLead Sponsor
1,559 Previous Clinical Trials
10,258,751 Total Patients Enrolled
38 Trials studying Schizophrenia
4,747 Patients Enrolled for Schizophrenia
Stephen Marder, MDPrincipal InvestigatorUniversity of California, Los Angeles
3 Previous Clinical Trials
257 Total Patients Enrolled
2 Trials studying Schizophrenia
217 Patients Enrolled for Schizophrenia

Media Library

Oxytocin nasal spray (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03245437 — Phase 4
Schizophrenia Clinical Trial 2023: Oxytocin nasal spray Highlights & Side Effects. Trial Name: NCT03245437 — Phase 4
Oxytocin nasal spray (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03245437 — Phase 4
Schizophrenia Research Study Groups: Oxytocin with Health Management, Oxytocin with SCST, Placebo with HM, Placebo with SCST
~15 spots leftby Oct 2025
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