Clinical trial NCT03932656: Latent Toxoplasmosis in Females With Borderline Personality Disorder
Official title: Latent Toxoplasmosis in Females With Borderline Personality Disorder - Occurrence, Clinical Features, and Impact on Effectiveness of Combined Pharmacotherapeutic and Psychotherapeutic Treatment
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Borderline Personality Disorder
Toxoplasmosis
Keywords: borderline personality disorder
latent toxoplasmosis
Toxoplasma gondii
pharmacotherapy
psychotherapy
clinical features
Lead sponsor: Palacky University
Sponsor class: OTHER
Collaborators: name: Palacky University
name: University Hospital Olomouc
First posted: 2019-05-01
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients with borderline personality disorder who will be hospitalized at the psychotherapeutic ward of the university hospital.

Brief summary: Borderline personality disorder is a common mental disorder with core features of affective dysregulation, impulsivity, and identity disturbance. Although this disorder is mostly understood as a result of a combination of biological factors (genes, temperament) and early aversive experiences (often of traumatic nature), recent data suggest that other factors may be important in its development and course. Preliminary findings show that patients with borderline personality disorder have higher prevalence of Toxoplasma seropositivity. This infection may manifest in symptoms such as affective dysregulation, aggression, suicidality, or anxiousness. As such, it may play a role in the psychopathology of the borderline personality disorder. The aim of this study is to explore the prevalence of Toxoplasma seropositivity in a sample of females with borderline personality disorder, its clinical correlates, and a potential impact on outcomes of an intensive six-week inpatient schema-therapeutic treatment. Results may enrich our understanding of this disorder and lead to improvements of the therapeutic approaches.


Eligibility criteria: Inclusion Criteria:

* Adult
* Female
* Borderline personality disorder diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders-5 criteria
* Signed informed consent

Exclusion Criteria:

* Current substance abuse disorder
* Psychotic disorder, bipolar disorder, organic mental disorder current or past
* Severe suicidal risk
* Severe somatic illness (e.g., endocrinopathy, oncologic, hematologic, cardiologic, or neurologic illness)

Primary outcomes:
measure: Immunoglobulin A detection in human serum
timeFrame: 1 day
measure: Immunoglobulin M detection in human serum
timeFrame: 1 day
measure: Immunoglobulin G detection in human serum
timeFrame: 1 day
measure: Severity of borderline personality symptoms
timeFrame: 1 year
Secondary outcomes:
measure: Borderline Evaluation of Severity over Time
timeFrame: 1 year
measure: Aggression Questionnaire
timeFrame: 1 year
measure: Suicide Behaviors Questionnaire-Revised
timeFrame: 1 year
measure: Beck Anxiety Inventory
timeFrame: 1 year
measure: Beck Depression Inventory-II
timeFrame: 1 year
measure: Dissociative Experiences Scale
timeFrame: 1 year
measure: Sheehan Disability Scale
timeFrame: 1 year
Other outcomes:
measure: Childhood Trauma Questionnaire
timeFrame: 1 day
measure: Parental Bonding Instrument Questionnaire
timeFrame: 1 day
measure: Internalized Stigma of Mental Illness Scale
timeFrame: 1 day
measure: The Experiences in Close Relationship-Revised Questionnaire
timeFrame: 1 day
Locations:
city: Olomouc
country: Czechia
facility: Department of Psychiatry, Palacky University, University Hospital Olomouc
Study officials:
affiliation: University Hospital Olomouc, Faculty of Medicine, Palacky University
name: Marie Ociskova, PhD
role: PRINCIPAL_INVESTIGATOR
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