Oxytocin Treatment of Schizophrenia

Completed · Not applicable

Conditions studied: Paranoia, Schizophrenia, Schizoaffective Disorder

In brief

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).

Key facts

Study ID

NCT01028677

Run by

University of North Carolina, Chapel Hill

People needed

17

Starts

2009-11-01

Expected to finish

2011-03-01

Last updated by the study team

2017-04-18

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of North Carolina Hospitals — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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