Schizophrenia Clinical Trial
Official title:
Does Acute Oxytocin Administration Enhance Social Cognition in Individuals With Schizophrenia?
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | August 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | West Los Angeles VA Healthcare Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
VA Greater Los Angeles Healthcare System |
United States,
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Davis MC, Lee J, Horan WP, Clarke AD, McGee MR, Green MF, Marder SR. Effects of single dose intranasal oxytocin on social cognition in schizophrenia. Schizophr Res. 2013 Jul;147(2-3):393-7. doi: 10.1016/j.schres.2013.04.023. Epub 2013 May 12. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Social Cognition Composite Measure | Our primary outcome measure will be a composite score created by calculating the mean of the four main social cognition measures assessed in this study (two "high-level" measures and two "low-level" measures). Because these measures are not on the same scale, we will first z-score (center and scale) each of the four measures at each time point using the baseline mean and standard deviation of the whole sample and then calculate the mean of the z-scores to create the composite social cognition score. | Visit 2 (baseline), Visit 3 (1 week following, post-treatment) | No |
Secondary | Theory of Mind Assessment (High Level Social Cognition) | The Awareness of Social Inference Test (TASIT Part III: Social Inference - Enriched) will be administered to assess theory of mind. | Visit 2 (baseline), Visit 3 (1 week following, post-treatment) | No |
Secondary | Empathy | Empathy was assessed using the Emotional Perspective Taking Task (EPTT) (Derntl et al., 2009). In this task, subjects are presented with 60 digital images depicting two individuals in a social interaction, with one individual's face masked. Subjects are asked to infer the emotional expression of the masked face, selecting between two choices. Scenes portray 5 basic emotions as well as neutrality and each image is displayed for 4 s each. | Visit 2 (baseline), Visit 3 (1 week following, post-treatment) | No |
Secondary | Social Perception Assessment (Low Level Social Cognition) | We will assess social perception using the Half-Profile of Nonverbal Sensitivity (Half-PONS). Brief scenes are shown that include facial expressions, voice intonations, and/or body gestures. Subjects select a label that best describes the situation. The dependent measure is the total number of correct labels. | Visit 2 (baseline), Visit 3 (1 week following, post-treatment) | No |
Secondary | Facial Affect Recognition (Low Level Social Cognition) | Participants are asked to identify facial expressions of emotion in still photographs from the standardized stimulus set developed by Ekman. The test includes digitized color photos of eight different posers displaying facial expressions of six basic emotions plus neutral expressions. On each trial, a photo and a list of the seven possible expressions are simultaneously presented on the screen. The participant verbally identifies the emotion he/she believes is correct and the experimenter enters the response. The dependent measure is the total number correct. | Visit 2 (baseline), Visit 3 (1 week following, post-treatment) | No |
Secondary | Positive and Negative Syndrome Scale (PANSS) for Schizophrenia Total Score | This is a frequently used instrument, initially developed by Kay, Opler, and Fiszbein, that assesses 30 different symptoms (categorized into positive, negative, and general psychopathology) on a scale from 1 to 7, based on clinical interview. It will be used to compare the psychopathology between the two treatment groups. The maximum Total Score on the scale is 210 and the minimum score is 30, with higher values indicating more severe symptoms. The maximum scale of 210 is the sum of the scores from each symptom category (positive symptoms = range 7 to 49; negative symptoms = range 7 to 49; general psychopathology = range to 16 to 112). Our outcome measure refers to the change in the PANSS Total Score. A greater decrease on the scale indicates greater improvement in symptoms (e.g., a participant with a change score of -20 improved more on the PANSS than a participant with a change score of -5). |
Visit 2 (baseline), Visit 3 (1 week following, post-treatment) | No |
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