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Oxytocin · 1 trial · 1 indication
We will assess emotion management, emotion perception, social context processing/social perception, theory of mind, attributional bias, and empathic accuracy. The primary summary measure for each test will be mean-centered and standardized to create a Z-score that will be averaged to create a single composite score for social cognition, serving as the primary outcome measure. Parallel follow-up analyses will be conducted on individual components to determine which measures are most affected by treatment. Similar secondary analyses will be employed for the event related potential (ERP) and basic cognition measures.
| Arm | Type | Description |
|---|---|---|
| Placebo+Social Cognitive Skills Training | ACTIVE_COMPARATOR | The training utilizes skill building techniques that are commonly used in psychiatric rehabilitation. These include breaking down complex social cognitive processes into their components and automating these skills through repetition and practice. The training programs will include 12 sessions and will be administered in a small group format (6-8 participants per group) twice a week for 6 weeks. The treatment groups will include individuals who are assigned to placebo. Each training session will last for about 90 minutes (1 hour training and 30 minutes between placebo administration and start of training). |
| Oxytocin+Social Cognitive Skill Training | EXPERIMENTAL | The training utilizes skill building techniques that are commonly used in psychiatric rehabilitation. These include breaking down complex social cognitive processes into their components and automating these skills through repetition and practice. The training programs will include 12 sessions and will be administered in a small group format (6-8 participants per group) twice a week for 6 weeks. The treatment groups will include individuals who are assigned to oxytocin. Each training session will last 90 minutes (1 hour training and 30 minutes between oxytocin administration and start of training). |
| Name | Type | Description |
|---|---|---|
| Oxytocin | DRUG | Oxytocin 40 IU, intranasal inhalation |
| Placebo | OTHER | Placebo, matched to Oxytocin, intranasal inhalation |
| Social Cognitive Skills Training | BEHAVIORAL | The training utilizes skill building techniques that are commonly used in psychiatric rehabilitation. These include breaking down complex social cognitive processes into their components and automating these skills through repetition and practice. The training programs will include 12 sessions and will be administered in a small group format (6-8 participants per group) twice a week for 6 weeks. Each training session will last for about 90 minutes (1 hour training and 30 minutes between drug administration and start of training). |
Inclusion Criteria: * Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders 4th edition * Stable on an antipsychotic medication * No change in antipsychotic dose of \>10% during the past 3 months Exclusion Criteria: * Unable to provide informed consent ...
Oxytocin is an investigational small molecule being studied for use in schizophrenia. It is being evaluated as a pharmacological approach to improve the outcome of social cognition training in patients with this condition. The drug is currently in Phase 1 clinical development.
Oxytocin is being developed by National Healthcare Corp., a company traded under the ticker NHC. The company is conducting clinical research on the drug for schizophrenia, with the drug currently in Phase 1 development.
Oxytocin is in Phase 1 clinical development for schizophrenia. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy.
Oxytocin has one completed clinical trial registered under NCT01517360, titled "Pharmacological Approach to Improve the Outcome of Social Cognition Training." This Phase 1 trial enrolled 27 male participants aged 18 years and older with schizophrenia in the United States.
Oxytocin is the drug name used in clinical development for this investigational treatment for schizophrenia. No alternative names have been established for this drug in the available clinical trial information.