The use of Oxytocin as adjunctive therapy for the treatment of schizophrenia: a randomized, double blind trial - OxIS (Oxytocin Intranasal in Schizophrenia)

IRCCS CENTRO SAN GIOVANNI DI DIO FATEBENEFRATELLI0 个研究点开始时间: 2013年4月10日最近更新: 2016年3月14日

适应症

试验速览

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•-Outpatients with a diagnosis of Schizophrenia, according to DSM-IV criteria, for at least one year, assessed via SCID-I/P.
•-A minimum PANSS total score of 55 (indicating moderate severity, due to ongoing AP treatment) at T0 and a score of at least 4 on the PANSS suspiciousness subscale.
•-A minimum CGI-S score of 4
•-Age between 18 and 35 years
•-A disorder duration of no longer than 5 years
•-Women of childbearing age must test negative for pregnancy at the time of enrolment
•- Have at least one family member, or a trusted person, who has daily contact with the patient, and can help him with the management of treatment.
•All patients must:
•-be on a therapeutic dose of a SGA (or a maximum 2 SGAs) with no major dose changes for at least 4 weeks.
•-have the ability to provide informed consent
•-be able to use a nasal spray
•-reside in the service catchment area
•-show evidence of no alcohol or substance abuse/dependence in the last year
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 80
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Diagnosis of mental retardation (IQ<70 as assessed via Wechsler Adult Intelligence Scale WAIS)
•-Diagnosis of organic mental disorder
•-History of no response to treatment with clozapine
•-Be on a antipsychotic depot therapy
•-History of hypersensitivity to OXT or vehicle
•-Alcohol or substance abuse/dependence in the last year
•-Presence of, or history of clinically significant allergic rhinitis as assessed by the treating clinician
•-Being pregnant or breastfeeding
•-Having given birth in the past 6 months or breast-feeding in the past 3 months
•-Low literacy as indicated by an inability to read and understand the consent form.

发起方

IRCCS CENTRO SAN GIOVANNI DI DIO FATEBENEFRATELLI