Background: A large body of research has shown that Oxytocin (OXT) is an important prosocial
peptide and there is also initial evidence that the central OXT system is altered in several
mental disorders that are characterized by severe social disturbances and deficits, such as
anxiety disorders with prominent social dysfunction (e.g., schizophrenia), mood disorders and
borderline personality disorder. OXT may reduce psychotic symptoms and may diminish certain
social cognition deficits that are not improved by current antipsychotic medications.
Aims: The project has two main aims, listed below:
1. To assess the efficacy of intranasal OXT in reducing negative symptoms in patients with
schizophrenia in association with second-generation antipsychotics (SGA);
2. To use an Emotional Priming Paradigm task to assess pre- and post-treatment change in
the patients general cognitive and emotional status.
Study Design: Randomized, double-blind, placebo-controlled, cross over design. Materials and
methods: Patients involved in the study will be recruited in six centres in the north of
Italy. Each subject (aged 18-45, with a duration of the disorder no longer than 10 years)
will be enrolled after a screening phase. 80 patients will be randomly assigned to either 40
IU OXT once daily or vehicle placebo, in addition to their pre-study antipsychotic medication
regimen: all reasonable attempts maintain the same SGA dosages throughout the study will be
made. The study ratio is 1:1. The total study duration for each individual subject will be
approximately 8 months, which includes an up to 7-day screening period, a baseline
randomization visit, and a four month long cross-over treatment period. Subjects will be
trained by researchers about the self-administration of intranasal OXT. A trustworthy
caregiver will be trained as well. Each patient will receive every morning a SMS text message
on his mobile phone as a reminder for OXT administration.
Before starting the treatment, all patients will be assessed with standardized assessment
instruments and will undergo an in depth neuropsychological assessment; additional
evaluations, including safety evaluations, will be performed at 4 and 8 month follow-ups.
The primary outcome measure will be the negative score in the Positive and Negative Syndrome
Scale (PANSS) performed at 2,4,6 and 8 months since the start of the treatment.