title: A double-blind randomized controlled trial of oxytocin nasal spray and social cognition training for young people with early psychosis.
abstract: 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.
authors: Brain & Mind Research Institute, University of Sydney, Sydney, Australia;
authors: Cristina
authors: C
authors: Cacciotti-Saija
authors: ARC Centre of Excellence in Cognition and its Disorders (CCD), Macquarie University, Sydney, Australia;
authors: Robyn
authors: R
authors: Langdon
authors: School of Psychiatry, University of New South Wales, Sydney, Australia;
authors: Philip B
authors: PB
authors: Ward
authors: Brain & Mind Research Institute, University of Sydney, Sydney, Australia;
authors: Ian B
authors: IB
authors: Hickie
authors: Brain & Mind Research Institute, University of Sydney, Sydney, Australia;
authors: Elizabeth M
authors: EM
authors: Scott
authors: Brain & Mind Research Institute, University of Sydney, Sydney, Australia;
authors: Sharon L
authors: SL
authors: Naismith
authors: Brain & Mind Research Institute, University of Sydney, Sydney, Australia;
authors: Loretta
authors: L
authors: Moore
authors: Brain & Mind Research Institute, University of Sydney, Sydney, Australia;
authors: Gail A
authors: GA
authors: Alvares
authors: Child Development Unit, The Children's Hospital at Westmead, Sydney, Australia.
authors: Marie Antoinette
authors: MA
authors: Redoblado Hodge
authors: Brain & Mind Research Institute, University of Sydney, Sydney, Australia; adam.guastella@sydney.edu.au.
authors: Adam J
authors: AJ
authors: Guastella
mesh_terms: D000293:Adolescent; D000328:Adult; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D059085:Nasal Sprays; D010121:Oxytocin / Q000008:administration & dosage / Q000494:pharmacology*; D011618:Psychotic Disorders / Q000188:drug therapy / Q000628:therapy*; D012938:Social Perception; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D059085:Nasal Sprays; D010121:Oxytocin
keywords: emotion recognition; neuropeptides; schizophrenia; social behavior