Antipsychotic Effects of Oxytocin

This is two-site clinical study taking place at UCSD and UCI. Approximately 71 patients at
each site will be randomly assigned to either intranasal oxytocin or vehicle placebo at this
site.

The total duration for each individual subject will be 6 weeks on study medication (placebo
or oxytocin).

Inclusion Criteria:

- Adult men or women, 21 years of age or older.

- Meet DSM-IV criteria for Schizophrenia.

- Women of childbearing potential must test negative for pregnancy at the time of
enrollment based on urine pregnancy test and agree to use a reliable method of birth
control during the study.

- Must be on a therapeutic dose of an atypical antipsychotic medication (examples but
not limited to Clozapine Olanzapine, Risperidone, Ziprasidone, Aripiprazole,
Seroquel) with no major dose changes for at least 4 weeks.

- A minimum PANSS total score of 55 at screening and baseline and a score of at least 4
(moderate) on the subscale of the PANSS (suspiciousness/persecution) at screening.

- Have a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4
(moderately ill) at baseline.

- Must be able to communicate effectively with the investigator and study coordinator
and have the ability to provide informed consent.

- Must be able to use nasal spray.

- Must demonstrate an acceptable degree of compliance with medication and procedures in
the opinion of the investigator.

Exclusion Criteria:

- Are pregnant or are breastfeeding (negative pregnancy test at screening).

- A urine drug screen performed at screening must not show evidence of recent use of
drugs of abuse.

- Any active medical condition that in the opinion of the investigator will interfere
with the objectives of the study.

- Are unsuitable in any way to participate in this study, in the opinion of the
investigator.

- Another current DSM-IV diagnosis other than Schizophrenia.

Permitted:

- Subjects on one SSRI, and/or sleep medication (diphenhydramine, zolpidem, zaleplon,
or diazepam), at a reasonable dose, as judged by the investigator, is permitted in
this study. Minor adjustments in sleep medication are acceptable. Patients will be
asked to notify the study doctor of any changes to sleep aids.