Proposed Study to Evaluate Oxytocin and CBSST for Social Dysfunction in Schizophrenia

A significant proportion of people with schizophrenia are characterized by impaired ability to socially engage with others, reflecting social aversion, decreased motivation, or impaired reinforcement value of social interactions. These impairments are linked to social skill deficits and reduced ability to identify emotional facial expressions and empathize. Current pharmacological interventions offer limited benefits for impaired social function, and psychosocial interventions provide only partial relief. The development of an effective intervention remains a central therapeutic challenge. Oxytocin, critical for normal social affiliative behavior, is hypothesized to enhance social affiliation by reducing anxiety, boosting prosocial motivation, or modulating social cue processing. People with schizophrenia often have decreased oxytocin levels, associated with impaired facial emotion identification and reduced prosocial behaviors.

This study is designed as a multi-phase investigation, including a 2-week Evaluation Phase, a 24-week Double-blind Treatment Phase, and a 3-month Follow-up Phase. The core intervention involves Oxytocin administration combined with Cognitive Behavioral Social Skills Training (CBSST). The primary objective is to determine whether this combined approach can enhance social function in individuals with schizophrenia. The double-blind design implies a rigorous comparison against a control arm, though specific details on dosage, route, or participant numbers (n) are not provided in this protocol description.