The Combination of Oxytocin with Mindfulness-Based Group Therapy Reduces Negative Symptoms in Schizophrenia Spectrum Disorders: A Triple-Blind, Placebo-Controlled, Randomized, Controlled Clinical Pilot Trial (OXYMIND)

Summary

Combining intranasal oxytocin with mindfulness-based group therapy may improve negative symptoms in schizophrenia spectrum disorders. In a pilot study, 47 participants received either oxytocin or placebo before four therapy sessions. Only the oxytocin group showed significant reductions in negative symptoms from baseline to post-intervention and at a 4-week follow-up, with small between-group effects favoring oxytocin at follow-up. No serious adverse events occurred. The findings support further large-scale trials.

Study at a glance

Abstract

Abstract Background Negative symptoms in schizophrenia spectrum disorders (SSD) remain insufficiently treated and require novel therapeutic approaches. Oxytocin may improve negative symptoms, although its effects appear highly context-dependent according to the social salience hypothesis. We conducted a randomized, triple-blind, placebo-controlled pilot study combining intranasal oxytocin with mindfulness-based group therapy (MBGT), hypothesizing that the positive social context of MBGT would enhance oxytocin-related effects. Methods 47 participants with SSD (34% female) were randomized to receive either 24 IU oxytocin (MBGT+OXT; n = 26) or placebo (MBGT+PLA; n = 21) before four MBGT sessions. Primary outcome was negative symptoms assessed with the Positive and Negative Syndrome Scale negative subscale (PANSS-N) at post-intervention and 4-week follow-up. Secondary outcomes included the Brief Negative Symptom Scale (BNSS), Self-Evaluation of Negative Symptoms Scale (SNS), and additional clinical measures. Linear mixed models estimated within- and between-group effects. Results Overall dropout rate was 14.89%, with one dropout potentially treatment-related. Blinding was successful. Participants completed 95.63% of sessions. Only the MBGT+OXT group showed significant improvements in PANSS-N from baseline to post-intervention (d = −0.74) and follow-up (d = −0.77), with a small between-group effect at follow-up (d = 0.39). BNSS total improved significantly only in the MBGT+OXT group from baseline to post-intervention ( d = −0.88) and follow-up ( d = −0.91), with between-group effects favoring MBGT+OXT at follow-up (d = −0.38). No serious adverse events occurred. Conclusions These findings suggest, oxytocin combined with MBGT may improve negative symptoms in SSD and support further large-scale trials. Clinical Trials Registration https://clinicaltrials.gov/study/NCT06136390 , Registration number: NCT06136390

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