N/A
N=24
Does Acute Oxytocin Administration Enhance Social Cognition in Individuals With Schizophrenia?
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01312272 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Social Cognition Composite Measure — 0.10; 0.23 Change in z-score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Oxytocin (Drug); Inactive placebo nasal spray (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- VA Greater Los Angeles Healthcare System
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Social Cognition Composite Measure |
0.10; 0.23 | — |
| SECONDARY Theory of Mind Assessment (High Level Social Cognition) |
-0.01; 0.18 | — |
| SECONDARY Empathy |
0.24; 0.61 | — |
| SECONDARY Social Perception Assessment (Low Level Social Cognition) |
0.15; 0 | — |
| SECONDARY Facial Affect Recognition (Low Level Social Cognition) |
0.05; 0.22 | — |
| SECONDARY Positive and Negative Syndrome Scale (PANSS) for Schizophrenia Total Score |
-10.83; -8.89 | — |
Summary
Individuals with schizophrenia have been found to have deficits in social cognition, which is defined as the functions that are engaged during social interactions. Social cognition has been found to be critical in predicting multiple aspects of community functioning. There are no currently available medications that have been consistently found to improve social cognition in individuals with schizophrenia. Oxytocin functions as a neurotransmitter that is thought to be involved in multiple aspects of social behavior and related emotions. In this study, we test the hypothesis that acute administration of intranasal oxytocin will improve social cognition in individuals with schizophrenia.
Eligibility Criteria
Inclusion Criteria
- Veteran being treated in the Veterans Administration Healthcare System
- Meet DSM-IV-TR criteria for Schizophrenia
- At least 6 months since any hospitalization or substantial increase in level of care for an acute exacerbation of psychotic symptoms
- At least 1 month since meeting the criteria for having a major depressive episode
- At least 6 months since any behaviors suggesting any potential danger to self or others
- Adherence to the regular administration of an antipsychotic medication (e.g., risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, paliperidone, iloperidone, asenapine, fluphenazine, haloperidol, loxapine, molindone, perphenazine, thiothixene, chlorpromazine, clozapine)
- Dose of antipsychotic medication not varying by more than 25% over the 3 months prior to study participation
- No acute medical problems
- Chronic medical conditions (e.g., hypertension, diabetes, dyslipidemia) consistently treated and stable for at least 3 months prior to study participation
- Ability to provide signed informed consent and to cooperate with study procedures
Exclusion Criteria
- Documented history of mental retardation or severe learning disability
- History of treatment with electroconvulsive therapy within 6 months prior to study participation
- History of neurological or neuropsychiatric condition (e.g., stroke, severe traumatic brain injury, epilepsy, etc.)
- Documented history of persistent substance abuse or dependence within 6 months prior to study participation
- History of hyponatremia within the past 6 months
- Allergic rhinitis or other inflammation of the nasal mucosa
Data sourced from ClinicalTrials.gov (NCT01312272). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.