Schizophrenia
Conditions
Interventions
Phase 1 - analysis of endogenous levels of oxytocin (plasma) in 50 men diagnosed with refractory schizophrenia using Clozapine and 50 healthy control men
Phase 2 - 25 men with refractory schizophrenia using clozapine and 25 healthy control men will receive 24 IU / ml intranasal oxytocin. Another 25 men with refractory schizophrenia using clozapine and
Drug
D26.660
Sponsors
Faculdade de Medicina de Ribeirão Preto
Flávia de Lima Osório
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: General: Men aged 18 to 50 years, literate, signing the Informed Consent Form. For the clinical group, the participants must have a diagnosis of Refractory Schizophrenia, with a disease duration between 10 and 15 years, be on an outpatient treatment, using Clozapine exclusively and without psychiatric comorbidities. For the control group, participants must have no current or previous psychiatric disorder and use any psychotropic drugs. For Phase 3 of the study, participants in the control group must be overweight (BMI greater than 25kg / m2).
Exclusion criteria
Exclusion criteria: For clinical and control group: presence of clinical diseases of great impact on the functioning of the organism, such as degenerative, neurological diseases, cancers, hematological, pulmonary, renal, liver, cardiovascular diseases and / or use of psychoactive substances. For Phase 3: participants using oral antidiabetics, lipid-lowering drugs, sibutramine, amphetamines, orlistat or other medications for the treatment of excess weight will also be excluded. Participants with schizophrenia who experience any change in their medication or therapeutic prescriptions during the period of participation in the study will be automatically excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1: baseline levels of endogenous oxytocin (analyzed through plasma, using Competitive Immunoenzymatic Assay -ELISA) ;Phase 2: recognition of facial emotions assessed by a computerized Facial Emotion Recognition Task, containing 24 stimuli of faces, in the form of a film, aimed at the assessment and recognition of six basic emotions - joy, fear, sadness, surprise, disgust and anger - in addition to neutral faces. The task is composed of the stimuli proposed by Ekman & Friesen (1976) and was standardized by Arrais et al (2010). The success rate, the time and the response bias will be evaluated, in addition to the intensity of the stimulus required for recognition.;Phase 2: social cognition - empathy, assessed by the Multifaceted Empathy Test (MET): computerized, evaluates cognitive and emotional empathy through a series of photographs that depict people in emotionally charged situations, with positive and negative emotions. To assess 'cognitive empathy', subjects are asked to infer the protagonist's emotional mental states. To assess ‘emotional empathy’, subjects are asked to assess their own tendency to share that emotion on a likert scale, ranging from 0 (nothing) to 9 (very).;Phase 2: theory of mind, assessed by a Theory of Mind Task (ToM): It consists of an application notebook with different illustrated stories and 26 objective questions that evaluate the Theory of Mind, through recognition of emotions, false belief, among others. It was adapted for use in the Brazilian context, by adults by Chagas et al (2017).;Phase 3: social cognition - recognition of facial emotions, assessed by a computerized Facial Emotion Recognition Task, containing 24 film-like stimuli for the purpose of evaluating and recognizing six basic emotions - joy, fear, sadness , surprise, disgust and anger - as well as neutral faces. The task is composed of the stimuli proposed by Ekman & Friesen (1976) and was standardized by Arrais et al (2010). The success rate, the time and the resp | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1: early emotional trauma as a mediating variable of oxytocin levels assessed by: a) Questionnaire On Childhood Traumas - (CTQ) b)Self-Assessment Inventory of Early Emotional Traumas - Brief Form (ETISR-SF);Phase 2: positive and negative symptoms, assessed by the Positive and Negative Syndrome Scale (PANSS) and by the Brief Psychiatric Assessment Scale (BPRS) ;Phase 2: Safety and Tolerability of acute use of Oxytocin at a dosage of 24 IU / ml, assessed by the Side Effects Rating Scale (UKU), in four dimensions of symptoms: psychiatric (10 items), neurological (8 items), autonomic (11 items), and others (19 items);Phase 3:positive and negative symptoms, assessed by the Positive and Negative Syndrome Scale (PANSS) and by the Brief Psychiatric Assessment Scale (BPRS) ;Phase 3: general cognition, assessed through the Cognitive Consensus Battery (MATRICS);Phase 3: metabolism: assessed by weight, measurement of glucose and lipid levels, 24-hour food recall survey techniques (qualitative assessment questionnaires for assessing food consumption), bioimpedance to assess body composition and calorimetry to measure energy metabolism.;Phase 3: Safety and Tolerability of the chronic use of Oxytocin at a dosage of 48 IU / ml or 80 IU / ml per day, assessed by the Side Effects Rating Scale (UKU), in four symptom dimensions: psychiatric (10 items), neurological ( 8 items), autonomous (11 items), and others (19 items) | — |
Countries
Brazil
Contacts
Public ContactFlavia Osório
Faculdade de Medicina de Ribeirão Preto
Outcome results
None listed