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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
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
2,918 Previous Clinical Trials
2,739,845 Total Patients Enrolled
254 Trials studying Schizophrenia
89,911 Patients Enrolled for Schizophrenia
University of California, Los AngelesLead Sponsor
1,564 Previous Clinical Trials
10,262,513 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
Eligibility Criteria:
This trial includes the following eligibility criteria:Awards:
This trial has 4 awards, including:- 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.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Oxytocin with Health Management
- Group 2: Oxytocin with SCST
- Group 3: Placebo with HM
- Group 4: Placebo with SCST
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