Mental Disorders
Conditions
Interventions
Phase I will consist of a cross-sectional study comparing groups (50 borderlines women x 100 healthy controls.) At this stage, plasma samples will be taken from the participants for evaluation of base
Drug
D26.660
F03.675
Sponsors
Faculdade de Medicina de Ribeirão Preto
Faculdade de Medicina de Ribeirão Preto
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: women over 18 years of age; literate; of childbearing age; in contraceptive use for more than six months; who agree to participate by signing the Free and Informed Consent Form approved by the Ethics and Research Committee of the HCFMRP; who agree to measure levels of estrogen and progesterone to delineate the menstrual cycle; that are in the follicular phase of the cycle. For inclusion in the TPB group, women should have: a diagnosis of BPD performed using the criteria established by the DSM-5 classification; being in outpatient treatment. In the control group, only women with no history of current or previous psychiatric disorder evaluated by SCID-5 will be admitted. In the study of continuous use, they will be admitted to women with BPD of childbearing age, over 18 years of age, without pretense of becoming pregnant within the next 6 months, who are literate and who agree to participate and sign the ICF approved by the HCFMRP Ethics and Research Committee. In addition, in this group, only women with a diagnosis of BPD will be accepted, based on the criteria established by the classification of DSM-5 (APA, 2014), in outpatient treatment; who agree not to modify their treatments during the study period.
Exclusion criteria
Exclusion criteria: Participants will be excluded from the study if they refer to clinical diseases that have a major impact on the functioning of the organism, such as degenerative diseases, neurological diseases, cancers, hematological, pulmonary, renal, hepatic and cardiovascular diseases; pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the associations between OXT and TPB thorght endogenous levels of OXT and intranasal OXT. | — |
Secondary
| Measure | Time frame |
|---|---|
| the effects of OXT on recognition of facial expressions of emotions, manifestation of BPD symptoms, emotional dysregulation and impulsivity in women with BPD and controls healthy.;To verify, in patients with BPD and in healthy controls, the tolerability and the safety of the use of 24UI / ml single dose of intranasal oxytocin;;To evaluate the adjuvant effects of continuous use (4 weeks) of 48 IU / ml daily given in two doses of 24 IU / ml of intranasal oxytocin (morning and evening) compared to placebo in performance in task of recognition of facial expression of emotions in the manifestation the symptoms of BPD, emotional dysregulation, depressive, anxious and hopeless symptoms, suicidal ideation, impulsivity and pain in women with BPD;;To evaluate the adjuvant effects of continuous use (4 weeks) of 80 IU / ml daily given in two doses of 40 IU / ml of intranasal oxytocin (morning and evening) compared to placebo in performance in task of recognition of facial expression of emotions, manifestation the symptoms of BPD, emotional dysregulation, depressive, anxious and hopeless symptoms, suicidal ideation, impulsivity and pain in women with BPD;;To measure the dose-response effect of the continuous use of two daily doses of 24 IU / ml and 40 IU / ml of intranasal oxytocin as an adjuvant treatment in women with BPD;;To verify the tolerability and the safety of the continuous use, twice a day, of doses of 24 IU / ml and 40 IU / ml of intranasal oxytocin in women with BPD.;To measure the effects of oxytocin on body image perception and on the decrease in overweight of BPD patients compared to healthy women with this characteristic. | — |
Countries
Brazil
Contacts
Public ContactBrisa Dias Macedo
Faculdade de Medicina de Ribeirão Preto
Outcome results
None listed