Daily Intranasal Oxytocin for Childhood-Onset Schizophrenia

Background: Recent studies with intranasal oxytocin administration indicate moderate efficacy in symptom reduction in adult patients with schizophrenia, and moderate to good response in improving social cognition in patients with autism. The majority (about 75%) of patients with childhood-onset schizophrenia (COS) continue to show impairing social and psychotic symptoms after drug treatment optimization, and almost 30% of children with COS have co-morbid autism spectrum disorder (ASD). Oxytocin may be a safe and effective adjunctive treatment to improve social cognition, reduce anxiety, and indirectly reduce psychotic symptoms in medication-stable COS patients. Objective: To study whether intranasal oxytocin (study medication) would be safe, improve emotional/social cognition, and reduce symptom severity in clinically stable COS children and whether the study medication would also result in specific neurocircuitry changes, as measured by multimodal neuroimaging. Study Population: 72 patients (36 per group) with COS, ages 10 and above will be recruited. All patients will be on stable medications for at least one month prior to this study. Design: Two-week double-blind, placebo-controlled, parallel design trial of daily intranasal oxytocin. Subsequent to the study period, a two-week extension of open label study medication will be offered to all participants, regardless of study group assignment. Outcome Measures: Primary Outcome Measures: To evaluate the safety of intranasal oxytocin in COS patients. To assess whether intranasal administration of oxytocin will improve both positive and negative symptoms of schizophrenia compared to placebo, as measured by PANSS, SAPS, SANS, and BPRS. To evaluate whether intranasal oxytocin has significant effects on the social and emotional processing and behavior of children with COS, as measured by the Diagnostic Analysis of Nonverbal Behavior (DANVA-2), Developmental Neuropsychological Assessment (NEPSY-2) standardized social perception battery, Brune Theory of Mind Pictures Stories Task, Reading the Mind in the Eyes Test. Social Responsiveness Scale (SRS). To measure alterations in neurocircuitry after oxytocin administration, as measured by fMRI, DTI, and MEG. To evaluate changes in blood plasma oxytocin levels measured over the course of the study.