title: Unaltered Oxytocin and Vasopressin Plasma Levels in Patients with Schizophrenia After 4 Months of Daily Treatment with Intranasal Oxytocin.
abstract: The neuropeptide oxytocin (OXT) has been proposed as a treatment for a number of neuropsychiatric disorders characterised by impaired social behaviour, including schizophrenia. Although several studies have reported the chronic administration of OXT to be safe and tolerable, its effects on circulating levels of OXT, as well as the related neuropeptide arginine vasopressin (AVP), have not been assessed. In the present study, in a within-subjects cross-over, double-blind, randomised controlled trial, we assayed the plasma levels of OXT and AVP in 31 patients with schizophrenia who were treated daily for 4 months with 40 IU of intranasal OXT or placebo. Our data indicate a mean ± SD baseline OXT concentration of 1.62 ± 0.68 pg/ml, as determined by radioimmunoassay, which did not display any significant variation after chronic treatment with OXT or placebo. Similarly, the mean ± SD baseline AVP value of 2.40 ± 1.26 pg/ml remained unchanged. The present study also assessed cardiovascular and body fluid indicators (osmolality, plasma sodium concentration and systolic blood pressure), as well as a parameter for food intake (body mass index), with all observed to remain stable. By reporting that daily treatment with 40 IU of intranasal OXT or placebo for 4 months does not impact on OXT and AVP plasma levels, nor on cardiovascular, body fluids and food intake parameters, the present study represents an important step towards developing OXT as a safe treatment.
authors.affiliation: CNR, Institute of Neuroscience, Milan, Italy.|Department of Medical Biotechnology and Translational Medicine, Università degli Studi di Milano, Milan, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Busnelli
authors.affiliation: IRCCS Saint John of God Clinical Research Centre, Brescia, Italy.
authors.forename: J
authors.initials: J
authors.lastname: Dagani
authors.affiliation: IRCCS Saint John of God Clinical Research Centre, Brescia, Italy.
authors.forename: G
authors.initials: G
authors.lastname: de Girolamo
authors.affiliation: Psychiatric Clinic, DISM, Università di Udine, Udine, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Balestrieri
authors.affiliation: Department of Clinical and Experimental Medicine, Psychiatry Sector, University of Pisa, Pisa, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Pini
authors.affiliation: Department of Mental Health, AO Desenzano del Garda, Italy.
authors.forename: F M
authors.initials: FM
authors.lastname: Saviotti
authors.affiliation: Department of Mental Health, Azienda ULSS 16, Padua, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Scocco
authors.affiliation: Department of Biomolecular Sciences, Service of Biostatistics, University of Urbino, Urbino, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Sisti
authors.affiliation: Department of Biomolecular Sciences, Service of Biostatistics, University of Urbino, Urbino, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Rocchi
authors.affiliation: CNR, Institute of Neuroscience, Milan, Italy.|Humanitas Clinical and Research Center, Rozzano, Italy.
authors.forename: B
authors.initials: B
authors.lastname: Chini
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D001794:Blood Pressure / Q000187:drug effects; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004435:Eating / Q000187:drug effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009481:Neurophysins / Q000097:blood* / Q000493:pharmacokinetics; D009994:Osmolar Concentration; D010121:Oxytocin / Q000008:administration & dosage* / Q000097:blood* / Q000493:pharmacokinetics / Q000627:therapeutic use; D011498:Protein Precursors / Q000097:blood* / Q000493:pharmacokinetics; D012559:Schizophrenia / Q000097:blood* / Q000188:drug therapy*; D012964:Sodium / Q000097:blood; D014667:Vasopressins / Q000097:blood* / Q000493:pharmacokinetics; D055815:Young Adult
chemical_list: C438657:AVP protein, human; D009481:Neurophysins; D011498:Protein Precursors; D014667:Vasopressins; D010121:Oxytocin; D012964:Sodium
keywords: chronic treatment; intranasal oxytocin; oxytocin dosage; radioimmunoassay; schizophrenia