EUCTR2012-004504-35-ITActive, not recruitingNot Applicable
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 sitesStarted: April 10, 2013Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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.
Investigators
Similar Trials
Not yet recruiting
Phase 3
A Clinical trial to study the effects of Intranasal Oxytocin Therapy for Treatmentof Negative Symptoms in SchizophreniaCTRI/2023/12/060817Central Institute of Psychiatry
Completed
Phase 2
abor induction for premature rupture of membranespremature rupture of membranes at term.Preterm spontaneous labour with preterm deliveryIRCT2016042627615N1Vice Chancellor for Research, Mashhad University of Medical Sciences86
Completed
Phase 2
Identification and clinical relevance of an oxytocin-deficient state: randomized, crossover, placebo-controlled pilot physiopathological study: GLP1 Study.2024-515588-67-00Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau52
Recruiting
Phase 2
Oxytocin & benzodiazepines2024-516262-11-00St. Olavs Hospital HF60
Not yet recruiting
Phase 4
Evaluation of the effects of oxytocin in patients with schizophreniaHealthy volunteersM01.774.500ObesitySchizophreniaRBR-4yr9mtFaculdade de Medicina de Ribeirão Preto