Oxytocin Treatment of Schizophrenia

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Purpose: Test whether intranasal administration of the neuropeptide, oxytocin, improves social cognition, social functioning and decreases paranoia and other psychotic symptoms in schizophrenia.

Participants: Up to 80 adults with schizophrenia for at least one year and with a high rating for paranoia.

Procedures (methods): Oxytocin or placebo will be administered twice daily in an intranasal spray (6 insufflations/dose or 24 IU) for 6 weeks. Before, during and at the end of the trial, each subject will undergo social cognitive measures (primary outcomes) and psychiatric symptom ratings (secondary outcomes).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Treatments: Oxytocin

Criteria

Inclusion Criteria:

• Meeting DSM-IV criteria for paranoid or undifferentiated schizophrenia for at least 1 year.

• Scoring > or equal to 4 on the suspiciousness/persecution (paranoia) subscale of the Positive and Negative Symptoms Scale (PANSS), a full PANSS score > or equal to 60: stability of symptom severity and on the same medication(s) and dose(s) for at least 1 month; low to moderate depressive symptoms.

Exclusion Criteria:

• Low literacy as indicated by an inability to read and understand the consent form.

• Dependence on substances other than tobacco or caffeine.

• Positive urine drug screen for illegal substances or drugs that have not been prescribed.

• Debilitating medical conditions (including AIDS; HIV infection alone will not be grounds for exclusion).

• Major surgery or trauma in the past year will be grounds for exclusion although subjects determined to be recovered and stable may be included at the discretion of the PI.

• Pregnancy, breast-feeding.

• Having given birth in the past 6 months or breast-feeding in the past 3 months.

• Individuals judged unable to learn self-administration of intranasal treatments and/or not sufficiently reliable to do so will be excluded.

• Abnormalities found during medical evaluation will be grounds for exclusion although subjects with laboratory measures barely outside the normal range may be included at the discretion of the Principal Investigator.