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临床试验/NCT03932656
NCT03932656撤回不适用

Latent Toxoplasmosis in Females With Borderline Personality Disorder - Occurrence, Clinical Features, and Impact on Effectiveness of Combined Pharmacotherapeutic and Psychotherapeutic Treatment

Marie Ociskova1 个研究点 分布在 1 个国家开始时间: 2021年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Immunoglobulin A detection in human serum

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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)

研究组 & 干预措施

Females with borderline personality disorder

干预措施: Combined schema-therapy and cognitive behavioral therapy (Behavioral)

Females with borderline personality disorder

干预措施: Psychopharmaceuticals (Drug)

结局指标

主要结局

Immunoglobulin A detection in human serum

时间窗: 1 day

ELISA detection of immunoglobulin A specific antibodies - a sensitive and specific marker of acute infection. Index of positivity is higher than 1,1.

Immunoglobulin M detection in human serum

时间窗: 1 day

ELISA detection of immunoglobulin M specific antibodies - a highly sensitive marker of acute infection. Index of positivity is higher than 1,1.

Immunoglobulin G detection in human serum

时间窗: 1 day

ELISA detection of immunoglobulin G specific antibodies - a marker of undergone infection. The cut-off score for positivity is set at higher than 6,6 IU/ml.

Severity of borderline personality symptoms

时间窗: 1 year

Assessed by modified Clinical Global Impression for borderline personality disorder which was developed by Pérez et al (2007). This rating scale measures severity of the nine diagnostic criteria of the disorder, along with its overall severity. In each item, a clinician chooses one number of a seven-point scale where 1 = normal, not at all ill and 7 = among the most extremely ill subjects. The scores in the items are not summed. Instead, each of the item enters statistical analyses separately.

次要结局

  • Beck Depression Inventory-II(1 year)
  • Dissociative Experiences Scale(1 year)
  • Sheehan Disability Scale(1 year)
  • Borderline Evaluation of Severity over Time(1 year)
  • Aggression Questionnaire(1 year)
  • Suicide Behaviors Questionnaire-Revised(1 year)
  • Beck Anxiety Inventory(1 year)

研究者

发起方
Marie Ociskova
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Marie Ociskova

Assistant Professor

Palacky University

研究点 (1)

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