A double-blind randomized controlled trial of oxytocin nasal spray and social cognition training for young people with early psychosis
Open accessAbstract
Social-cognitive deficits contribute to poor functional outcomes in early psychosis; however, no effective pharmacological treatments exist for these problems. This study was the first to investigate the efficacy of an extended treatment of oxytocin nasal spray combined with social cognition training (SCT) to improve social cognition, clinical symptoms, and social functioning in early psychosis. In a double-blind, randomized, placebo-controlled, between-subjects trial, 52 individuals (aged 16-35 years) diagnosed with an early psychosis schizophrenia-spectrum illness were recruited. Participants received oxytocin (24 International Units) or placebo nasal spray twice-daily for 6 weeks, combined with group SCT (2 × 1 hour weekly sessions for 6 weeks). An additional dose of oxytocin was administered before each weekly session. Assessments were conducted at baseline, post-treatment, and at 3-month follow-up. Primary outcomes included the Reading the Mind in the Eyes Test, the Scale for the Assessment of Positive and Negative Symptoms, and the Social Functioning Scale. Secondary outcomes included self-report and behavioral assessments of social cognition, symptom severity, and social functioning. Results showed that on all primary and secondary outcomes, there was no benefit of oxytocin nasal spray treatment in comparison to placebo. Exploratory post hoc analysis suggested that increased use of nasal spray was, however, associated with reductions in negative symptoms in the oxytocin condition only. This study represents the first evaluation of oxytocin treatment for early psychosis. Although results suggest no benefit of oxytocin treatment, results also highlight an urgent need to consider nasal spray delivery and dose-related variables for future clinical trials.
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Recent trials found no effect of intranasal oxytocin in early psychosis.
“or in early psychosis (104)”
From Intranasal Oxytocin: Myths and Delusions (2016) · cites this paper as [104]
Several recent trials meet some of these recommended conditions, especially by reporting clear primary outcomes.
“Several recent trials conform to some of these conditions, particularly in reporting clear primary outcomes.”
From Intranasal Oxytocin: Myths and Delusions (2016) · cites this paper as [104]
Several studies have reported lower oxytocin levels in ASD, while others have not exhibited any differences, and one report of increased oxytocin levels in ASD.
“Several studies have reported lower oxytocin levels in ASD, [17][18][19] while others have not exhibited any differences, 20,21 and one report of increased oxytocin levels in ASD.22”
From Beyond the hype and hope: critical considerations for intranasal oxytocin research in autism spectrum disorder (2017) · cites this paper as [20]
A series of negative results, mixed meta-analytic results and doubts surrounding oxytocin research methods dampened initial enthusiasm.
“However, a series of negative results,24, 25, 26 mixed meta-analytic results27 and doubts surrounding oxytocin research methods28 somewhat dampened initial enthusiasm.”
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- Authors
- Cacciotti-Saija, C., Langdon, R., Ward, P. B., Hickie, I. B., Scott, E. M., Naismith, S. L., Moore, L., Alvares, G. A., Redoblado Hodge, M. A., & Guastella, A. J.
- Affiliations
- ARC Centre of Excellence in Cognition and its Disorders (AU)
- UNSW Sydney (AU)
- The University of Sydney (AU)
- Corresponding author
- Guastella, Adam J.
- ORCID
- Venue
- Schizophrenia Bulletin
- Publisher
- Oxford University Press (OUP)
- Published
- 2014-06-23
- Volume
- 41
- Issue
- 2
- Pages
- 483-493
- ISSN
- 0586-7614 (ISSN-L)
- 1745-1701
- PMC
- PMC4332939
- OpenAlex
- W2126398688
- Cited by
- 119
- References
- 61
- Citations by year
- 2026: 3 · 2025: 3 · 2024: 6 · 2023: 7 · 2022: 8 · 2021: 10 · 2020: 6 · 2019: 15 · 2018: 13 · 2017: 17 · 2016: 12 · 2015: 15 · 2014: 2 · 2013: 1
- FWCI
- 11.70
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Schizophrenia Bulletin (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Social Sciences › Psychology › Social Psychology › Neuroendocrine regulation and behavior
- Social Sciences › Psychology › Clinical Psychology › Psychoanalysis and Psychopathology Research
- Keywords
- oxytocin, nasal spray
- MeSH terms
- Adolescent, Adult, Combined Modality Therapy, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Oxytocin, Psychotic Disorders, Social Perception, Cognitive Behavioral Therapy, Treatment Outcome, Young Adult, Nasal Sprays
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