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A 12-week randomized controlled trial of twice-daily intranasal oxytocin for social cognitive deficits in people with schizophrenia.

ABSTRACT: Social cognition is impaired in people with schizophrenia and these deficits are strongly correlated with social functioning. Oxytocin is a hypothalamic peptide that contributes to maternal infant bonding and has diverse pro-social effects in adults. This study tested the hypothesis that 12weeks of intranasal oxytocin will improve social cognitive function in outpatients with schizophrenia and schizoaffective disorder. Sixty-eight eligible participants were randomized to oxytocin (24IU twice daily) or placebo. Social cognitive function was assessed using the Emotion Recognition-40, Brüne Theory of Mind, Reading the Mind in the Eyes test, Trustworthiness task and Ambiguous Intentions Hostility Questionnaire at baseline, 6weeks and 12weeks. In addition, social function was assessed using the Specific Levels of Functioning Scale and a role-play test, and psychopathology was assessed using the Positive and Negative Syndrome Scale (PANSS). Fifty-five participants completed the 12-week trial. The study found no evidence for a differential advantage of oxytocin over placebo on social cognition. Among secondary outcomes, there was a modest advantage for oxytocin over placebo on a component of social functioning, although there was also evidence that the placebo group outperformed the oxytocin group on the role-play task. No between-group differences emerged on measures of psychopathology in pre-specified comparisons, but oxytocin showed significant within-group reduction in PANSS negative symptoms and significant between-group improvement in negative symptoms in the schizophrenia subgroup. Further testing is needed to clarify whether oxytocin has therapeutic potential for social cognitive deficits and/or negative symptoms in people with schizophrenia.

SUBMITTER: Jarskog LF

PROVIDER: S-EPMC5474129 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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A 12-week randomized controlled trial of twice-daily intranasal oxytocin for social cognitive deficits in people with schizophrenia.

Jarskog L Fredrik LF Pedersen Cort A CA Johnson Jacqueline L JL Hamer Robert M RM Rau Shane W SW Elliott Tonya T Penn David L DL

Schizophrenia research 20170113

Social cognition is impaired in people with schizophrenia and these deficits are strongly correlated with social functioning. Oxytocin is a hypothalamic peptide that contributes to maternal infant bonding and has diverse pro-social effects in adults. This study tested the hypothesis that 12weeks of intranasal oxytocin will improve social cognitive function in outpatients with schizophrenia and schizoaffective disorder. Sixty-eight eligible participants were randomized to oxytocin (24IU twice dai ...[more]

PMID: 28094169

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Project description: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. Methods: 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 twice in biweekly 1-hour sessions, for a total of 48 sessions over 24 weeks. Birchwood Social Functioning Scale (SFS) 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; and the Scale for the Assessment of Negative Symptoms (SANS) total score was used to assess negative symptoms. Results: In the intent-to-treat analyses, there were no significant group differences in the SFS total score (Treatment × Week interaction: F = 0.96; df = 2, 40; P = .39) or ABS total score (Treatment × Week interaction: F = .12; df = 2, 39.7; P = .89). There was a trend for a significant reduction in defeatist beliefs among the participants randomized to oxytocin (Treatment × Week interaction: F = 2.86; df = 2, 67.2; P = .07). There were no significant group differences in SANS total score (Treatment × Week interaction: F = 0.96; df = 6, 39.7; P = 0.46), though the interpretation of the effect of oxytocin on SANS total score was complicated by the presence of a significant site effect: there was a significant placebo effect at the California site, which was markedly greater in magnitude than the observed oxytocin effect for these symptoms. Conclusion: The results of the intent-to-treat analyses provide minimal support for the utility of add-on intranasal oxytocin to CBSST for improvement in social function. Oxytocin was associated with trend improvement in defeatist attitudes and greater reduction in negative symptoms at one of the two study sites. (clinicaltrials.gov, trial number: NCT01752712)

Dataset Information

A 12-week randomized controlled trial of twice-daily intranasal oxytocin for social cognitive deficits in people with schizophrenia.

Publications

A 12-week randomized controlled trial of twice-daily intranasal oxytocin for social cognitive deficits in people with schizophrenia.

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