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临床试验/NCT02225600
NCT02225600暂停不适用

The Effect of Oxytocin Administration on Interpersonal Cooperation in Borderline Personality Disorder Patients and Healthy Adults: A Pilot Behavioral Study

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年8月26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
暂停
入组人数
40
试验地点
1
主要终点
Trust Game Affect Ratings

研究概览

简要总结

The study will examine behavioral patterns and underlying neural correlates which distinguish patients with borderline personality disorder (BPD) from healthy subjects as they participate in a two-person trust game and will determine whether administration of intranasal oxytocin (OT) will normalize trust game performance and concomitant neural processing in the BPD group.

详细描述

This is a pilot study to support submission of a larger-scale federally funded study. The study is designed to develop new strategies for treating the severe interpersonal dysfunction in borderline personality disorder (BPD) by modeling the interpersonal disturbance in BPD in the laboratory, identifying its neural correlates and determining whether the social neuropeptide, oxytocin, can ameliorate the interpersonal dysfunction. The study will examine behavioral patterns and underlying neural correlates which distinguish patients with borderline personality disorder (BPD) from healthy subjects as they participate in a two-person trust game and will determine whether administration of intranasal oxytocin (OT) will normalize trust game performance and concomitant neural processing in the BPD group.

The specific aims of the study are: 1) to determine whether BPD patients and healthy controls (HC) differ in their pattern of investing in a trustee when the trustee behaves benevolently or malevolently towards them or suddenly becomes malevolent after a period of benevolence (or vice-versa) in a multi-round economic exchange game ("The Trust Game"), and 2) to determine the effect upon behavior of the administration of 40 IU intranasal oxytocin relative to placebo in BPD subjects and HC's engaged in the Trust Game.

Subjects are being recruited and may participate in the Trust Game task, but intranasal administration of oxytocin has temporarily been held because of the COVID-19 pandemic.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BPD subjects meets criteria for DSM-IV Borderline Personality Disorder.
  • 18 to 55 years old
  • Healthy controls are free of any lifetime DSM-IV Axis I or Axis II diagnosis. However, to avoid a group of HC's too highly groomed and unrepresentative of the general population subjects meeting criteria for a past Axis I diagnosis of adjustment, dysthymic, or depressive NOS disorders, specific phobias, and sleep disorders will not be excluded. Subjects will not be excluded for a non-IV substance abuse disorder more than 6 months prior to enrollment.
  • All subjects will be free of psychotropic medications for 2 weeks (6 weeks for fluoxetine).
  • Subjects may be enrolled in psychotherapy.

排除标准

  • BPD subjects not meeting DSM-IV criteria for past or present bipolar I disorder, schizophrenia, schizoaffective disorder, substance dependence, head trauma, CNS neurological disease, seizure disorder or current major depression. Since depression is commonly associated with BPD, too stringent a depression exclusion criterion would yield a clinically atypical BPD sample. For this reason, BPD patients with Axis I depressive disorders other than major depression and those with a past history of major depression will not be excluded.
  • Substance abuse disorder in the prior 6 months
  • Significant medical illness
  • Pregnancy
  • Metallic foreign-bodies that contraindicate MRI

研究组 & 干预措施

patients with BPD

Other

cross-over administration of 40 IU oxytocin, 24 IU oxytocin and placebo

干预措施: Placebo (Drug)

patients with BPD

Other

cross-over administration of 40 IU oxytocin, 24 IU oxytocin and placebo

干预措施: 40 IU Intranasal Oxytocin (Drug)

patients with BPD

Other

cross-over administration of 40 IU oxytocin, 24 IU oxytocin and placebo

干预措施: 24 IU intranasal Oxytocin (Drug)

healthy patients

Active Comparator

Cross-over of 40 IU oxytocin, 24 IU oxytocin and placebo

干预措施: 40 IU Intranasal Oxytocin (Drug)

healthy patients

Active Comparator

Cross-over of 40 IU oxytocin, 24 IU oxytocin and placebo

干预措施: Placebo (Drug)

healthy patients

Active Comparator

Cross-over of 40 IU oxytocin, 24 IU oxytocin and placebo

干预措施: 24 IU intranasal Oxytocin (Drug)

结局指标

主要结局

Trust Game Affect Ratings

时间窗: up to 4 weeks

Behavioral differences between groups based on Scale with 1= most negative to 5=most positive

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Harold W Koenigsberg, MD

Professor

Icahn School of Medicine at Mount Sinai

研究点 (1)

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