title: Do we need oxytocin to treat schizophrenia? A randomized clinical trial.
abstract: BACKGROUND
  Schizophrenia is a disabling complex mental disorder and despite all available treatment, many patients unfortunately remain partial- or non-responders. A large body of research has shown that oxytocin is an important prosocial peptide and there is initial evidence that the central oxytocin system is altered in several mental disorders. The aim of this study was to test the efficacy of oxytocin, as augmentation therapy, in a sample of patients with schizophrenia.
  
  
  METHODS
  We conducted an 8-month randomized, double-blind, controlled trial with a crossover design. We wanted to test the hypothesis that intranasal oxytocin could reduce symptoms in 32 patients with schizophrenia aged 18-45 with short-medium illness duration (<11 years). Patients were randomly assigned to either 40 International Units oxytocin once daily or a vehicle placebo group, in addition to their pre-study antipsychotic medication regimen. We subsequently conducted a multi-dimensional assessment including psychopathological, psychosocial and neuropsychological aspects.
  
  
  RESULTS
  Positive and Negative Syndrome Scale scores showed no significant differences in treatment effects between the experimental group and controls. Furthermore, no treatment effects were shown in any of the rating scales used in this study. However, a statistically significant period effect was shown in most outcome measurements.
  
  
  CONCLUSIONS
  In our trial, oxytocin did not add any significant beneficial effects to anti-psychotic treatment in terms of clinical symptoms or psychosocial functioning. Further research should focus on different ways to administer oxytocin, or investigate predictors (such as past traumas, or biomarkers), which could identify subgroups of patients with different treatment responses to oxytocin. ClinicalTrials.gov Identifier: NCT01699997. ID number: RF-2010-2311148. URL: https://clinicaltrials.gov/ct2/show/NCT01699997.
authors.affiliation: IRCCS Saint John of God Clinical Research Centre, Via Pilastroni 4, 25125 Brescia, Italy.
authors.forename: Jessica
authors.initials: J
authors.lastname: Dagani
authors.affiliation: Department of Biomolecular Science, University of Urbino, Piazza Rinascimento 6, 61129 Urbino, Italy.
authors.forename: Davide
authors.initials: D
authors.lastname: Sisti
authors.affiliation: Psychiatric Clinic, University of Pisa, via Roma 67, 56100 Pisa, Italy.
authors.forename: Marianna
authors.initials: M
authors.lastname: Abelli
authors.affiliation: Psychiatric Clinic, University of Pisa, via Roma 67, 56100 Pisa, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Di Paolo
authors.affiliation: Psychiatric Clinic, University of Pisa, via Roma 67, 56100 Pisa, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Pini
authors.affiliation: Department of Mental Health, A. O. Desenzano del Garda, Piazza Donatori di Sangue 1, 25024 Leno, Brescia, Italy.
authors.forename: Sara
authors.initials: S
authors.lastname: Raimondi
authors.affiliation: Department of Biomolecular Science, University of Urbino, Piazza Rinascimento 6, 61129 Urbino, Italy.
authors.forename: Marco B
authors.initials: MB
authors.lastname: Rocchi
authors.affiliation: Department of Mental Health, A. O. Desenzano del Garda, Piazza Donatori di Sangue 1, 25024 Leno, Brescia, Italy.
authors.forename: Francesco M
authors.initials: FM
authors.lastname: Saviotti
authors.affiliation: Department of Mental Health (ULSS 16), via Buzzaccarini 1, 35124 Padua, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Scocco
authors.affiliation: Department of Mental Health (ULSS 16), via Buzzaccarini 1, 35124 Padua, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Totaro
authors.affiliation: Psychiatric Clinic, University of Udine, P.le S.M.Misericordia 15, 33100 Udine, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Balestrieri
authors.affiliation: IRCCS Saint John of God Clinical Research Centre, Via Pilastroni 4, 25125 Brescia, Italy. Electronic address: gdegirolamo@fatebenefratelli.eu.
authors.forename: Giovanni
authors.initials: G
authors.lastname: de Girolamo
mesh_terms: D000293:Adolescent; D000328:Adult; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010121:Oxytocin / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D012559:Schizophrenia / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D010121:Oxytocin