104. Combined CBSST and Oxytocin for Social Function in People With Schizophrenia

Abstract

Background: A significant proportion of people with schizophrenia are characterized by impaired ability to socially engage with others, which may reflect social aversion secondary to defeatist beliefs; decreased motivation for social interactions; and/or impairment in the normal reinforcement value of social interactions. Unfortunately, pharmacological interventions have limited benefits for impaired social function, whereas psychosocial interventions provide only partial benefit for this critical aspect of the illness. The development of an effective intervention for functional outcomes remains a central therapeutic challenge. The current study assessed whether the addition of intranasal oxytocin to Cognitive Behavioral Social Skills Training (CBSST) improved social function. Method(s): Participants with DSM-IV-TR schizophrenia or schizoaffective disorder entered a 24-week, double-blind, placebo-controlled, randomized clinical trial with a 3-month follow-up evaluation. The study was conducted at two sites: Maryland and California. Participants were randomized to either: intranasal oxytocin 36 I.U. (3 sprays) BID (n =31) or intranasal placebo-oxytocin 3 sprays BID (n= 31). All participants received CBSST, which was delivered in four 6-session modules (cognitive, social and problem-solving CBSST modules plus a module adapted from Social Cognition and Interaction Training). The modules were delivered in twice weekly 1-hour sessions, for a total of 48 sessions over 24 weeks. Birchwood Social Functioning Scale (BSFS) was used to assess social function; the Defeatist Performance Attitude Scale (DPAS) was used to assess defeatist beliefs; the Asocial Beliefs Scale (ABS) was used to assess social disinterest and aversion. The Brief Psychiatric Rating Scale (BPRS) total score was used to assess global psychopathology and the BPRS positive symptom items was used to assess positive symptoms; the Scale for the Assessment of Negative Symptoms (SANS) total score was used to assess negative symptoms; and the Calgary Depression Scale (CDS) total score was used to assess depressive symptoms. The primary analytic approach for the efficacy measures was a mixed model for repeated measures ANCOVA, adjusting for the baseline score. Result(s): The primary outcome measure was the BSFS total score. There were no significant time (F=1.11; df=1,49.3; p=0.30), treatment (F=1,44; df=1,49.3; p=0.24), or treatment x time (F=1.44; df=1,49.3; p=0.24) effects. The DPAS and ABS were used to assess the effect of CBSST on defeatist attitudes and asocial beliefs; there was a trend effect of time for the DPAS (F=3.17; df=1,41.4; p=0.08). There were no significant effects for treatment (F=0.00; df=1,43.9; p=0.95) or treatment x time (F=1.78; df=1,41.4; p=0.19). There was also a trend effect of time for the ABS (F=3.16; df=1,44.1; p=0.08). There were no significant effects for treatment (F=0.20; df=1,47.2; p=0.66) or treatment x time (F=0.17; df=1,44.1; p=0.68). The time effect for the SANS total score was not significant (F=0.86; df=5,41.4; p=0.52). However, when the SANS items were divided into those related to emotional expression and avolition/asociality, there was a trend time effect for the avolition/asociality composite measure (F=2.44; df=5,41.4; p=0.05). There were no significant treatment (F=0.11; df=1,50.3; p=0.75) or treatment x time (F=1.10; df=5,41.4; p=0.37) effects for SANS total score. There were significant time (F=3.61; df=5,35.4; p=0.01) and treatment (F=5.06; df+1,47.7; p=0.03) effects for BPRS total score. The treatment x time effect was not significant (F=0.93; df=5,35.4; p=0.48). There was also a significant treatment effect for BPRS positive symptom item score (F=4.45; df=1,51.0; p=0.04). There was a trend for the time effect (F=2.31; df=5,37.1; p=0.06); the treatment x time effect was not significant (F=2.26; df=5,37.1; p=0.48). The time (F=0.69; df=5,43.0; p=0.63) and treatment x time (F=0.50; df=5,43.0; p=0.77) effects for CDS total score were not significant. However, there was a trend for the treatment effect (F=3.09; df=1,51.8; p=0.08). Conclusion(s): The study results suggest that there is no significant benefit of oxytocin for social function, as measured by BSFS total score. The observed time effects for the DPAS, ABS, and SANS avolition/asociality are consistent with the results from previous CBSST studies and suggest that CBSST was effective in the current study. The addition of oxytocin to CBSST did result in a significant reduction of global psychopathology and positive symptoms. There was no effect of oxytocin on negative symptoms; there was a trend effect for depressive symptoms. The observed effect on global psychopathology and positive symptoms is consistent with previous studies, which used high dose oxytocin. (clinicaltrials.gov, trial number: NCT01752712).