The use of Oxytocin for the treatment of schizophrenia

• Conditions: Schizophrenia; MedDRA version: 14.1Level: HLGTClassification code 10039628Term: Schizophrenia and other psychotic disordersSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2012-004504-35-IT
• Lead Sponsor: IRCCS CENTRO SAN GIOVANNI DI DIO FATEBENEFRATELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-10
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-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

Exclusion Criteria

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): The trials primary outcome measure will be the difference in PANSS negative score, as measured at T0 and at 4 and 8 months.;Timepoint(s) of evaluation of this end point: T0, 4 and 8 Months;Main Objective: To assess the efficacy of intranasal OXT in reducing negative symptoms in patients with SZ (as evaluated with PANSS), in association with standard SGA treatment; recruited patients will be aged 18-35 years and will have a disorder duration of no longer than 5 years.;Secondary Objective: To use an Emotional Priming Paradigm (EPP) task to assess pre- and post-treatment change in the patients general cognitive and emotional status.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary end-points will be the PANSS total score, the Brief Assessment of Cognitive deficits in Schizophrenics (BACS) score and the Reading the Mind in the Eyes Test (RMET) score changes from T0 to final assessment and changes in EPP task reaction times and accuracy.;Timepoint(s) of evaluation of this end point: T0, 4 and 8 Months