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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Social Cognition Composite Score
Secondary outcome measures
Composite score of non-social cognition from the MATRICS Consensus Cognitive Battery
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
2,783 Previous Clinical Trials
2,689,007 Total Patients Enrolled
248 Trials studying Schizophrenia
89,304 Patients Enrolled for Schizophrenia
University of California, Los AngelesLead Sponsor
1,529 Previous Clinical Trials
10,277,682 Total Patients Enrolled
38 Trials studying Schizophrenia
4,770 Patients Enrolled for Schizophrenia
Stephen Marder, MDPrincipal InvestigatorUniversity of California, Los Angeles
3 Previous Clinical Trials
276 Total Patients Enrolled
2 Trials studying Schizophrenia
236 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What psychological maladies are ameliorated by employing Social Cognition Skills Training?
"Social Cognition Skills Training is frequently administered to treat hemorrhage and has been applied with success in cases of labour, uterine contraction and inducing labor."
Answered by AI
Is enrollment still possible for this research endeavor?
"Affirmative. According to the clinicaltrials.gov listing, this medical study is accepting applicants from 1 site and needs 120 people in total for its trial. It was first published on April 1st 2018 and last updated September 1st 2022."
Answered by AI
What criteria must participants satisfy to be included in this clinical trial?
"This research study is in search of 120 participants between 18 and 65 years old suffering from schizophrenia or schizoaffective disorder."
Answered by AI
What impact has Social Cognition Skills Training been demonstrated to have on individuals?
"As this is a Phase 4 trial, indicating an approved treatment option, Social Cognition Skills Training was given the highest score of 3 for safety."
Answered by AI
What is the current size of this research endeavor?
"Affirmative. According to the records found on clinicaltrials.gov, this experiment is still accepting participants and was first posted in April 2018. The most recent update occurred on September 1st 2022, with an aim of enrolling 120 people at a single site."
Answered by AI
Are there any age restrictions for participating in this medical trial?
"This study seeks participants aged 18-65."
Answered by AI
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