Oxytocin Treatment of Social Cognitive and Functional Deficits in Schizophrenia

Completed · Phase 1

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

Purpose: Test whether intranasal administration of the neuropeptide, oxytocin, improves social cognition, psychotic symptoms and social functioning in schizophrenia. Participants: 80 adults with schizophrenia or schizoaffective disorder for at least one year. Procedures (methods): Oxytocin or placebo will be administered twice daily in an intranasal spray for 12 weeks. Before, during and at the end of the trial, each subject will undergo psychiatric symptom ratings and tests of mental abilities used in social functioning, cognition, and social competence.

Key facts

Study ID

NCT01394471

Run by

University of North Carolina, Chapel Hill

People needed

68

Starts

2011-07-01

Expected to finish

2015-01-01

Last updated by the study team

2015-06-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18-65 yrs of age;
• currently meeting DSM-IV criteria for schizophrenia or schizoaffective disorder with onset occurring > 1 year prior to enrollment in the study;
• score of <24 on the Reading the Mind in the Eyes Test ("Eyes Test", Baron-Cohen, et al 2001), which represents 0.5 SD below the mean in a large normative sample OR
• get a minimum score of "3" on at least two of the following "social" items on the PANSS ratings: suspiciousness/persecution (ideation), hostility, passive/apathetic social withdrawal, uncooperativeness, active social avoidance,
• stable symptoms as well as being on the same medication and psychosocial therapy regimen for > 1 month.

You may not qualify if…

• current or lifetime history of schizoaffective (bipolar type), delusional, other psychotic (shared, substance-induced, due to a medical disorder) disorders, bipolar, cyclothymic, somatoform, dissociative, eating or personality disorders, unipolar major depressive episodes with psychotic features, dementia;
• history of mania or hypomania within the past two years
• substance use or abuse disorder during the past 3 months (except tobacco, caffeine);
• treatment currently or within the past 6 months with high dose sedative-hypnotics, stimulants, chronic glucocorticoids (other medications that are adequately controlling acute or chronic disorders [e.g., hypertension, diabetes, hypo or hyperthyroidism, asthma, allergies, mild infections etc.] are allowed);
• debilitating or inadequately controlled medical conditions (including dialysis, HIV infection without AIDS is not exclusionary);
• major surgery/trauma in the past 4 months;
• pregnancy, childbirth or breast-feeding in the past year;
• significant physical exam, laboratory or EKG abnormalities;
• reading level < 5th grade on the Wide Range Achievement Test (WRAT, Wilkinson 1993);
• inability to read English well enough to complete study questionnaires.

Where it is running

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

Full record on ClinicalTrials.gov

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