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临床试验/NCT02797873
NCT02797873Unknown不适用

Emotional and Non-emotional Regulation in Patients With Emotional Instability Personality Disorder (EIP) and Attention Deficit Hyperactivity Disorder (ADHD) Symptoms

Karolinska Institutet0 个研究点目标入组 60 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
主要终点
Reaction times in Stroop task

研究概览

简要总结

The purpose of this study is to investigate how emotional and non-emotional regulation processes differ in EIP patients (with different levels of ADHD symptoms/ADHD-comorbidity) compared to controls. The investigators will test these participants' abilities to regulate emotional and non-emotional processes, reward anticipation and reward receipt while they undergo functional magnetic resonance imaging (fMRI). The participants' motor inhibition capacity on a behavioral level will also be investigated.

The hypothesis is that EIP patients will present with more deficits in emotion regulation processes compared to controls, even when controlling for ADHD symptoms. It is also hypothesized that higher levels of ADHD symptoms will correlate with dysfunctional non-emotional regulation processes, on a behavioral as well as brain mechanistic level.

详细描述

Background: Comorbidity of Emotional Instability Personality Disorder (EIP) and Attention Deficit Hyperactivity Disorder (ADHD) is common, and the two patient groups partially exhibit similar problems. The main hypothesis is that the two disorders are mechanistically related. The investigators believe that the mechanisms underlying the problems are linked to two parallel regulating systems in the brain. Here, prefrontal and anterior cingulate systems are in focus. The first system - including the dorsolateral prefrontal cortex (dlPFC) and the caudal anterior cingulate cortex (cACC) - regulates non-emotional (and exteroceptive) information. The other system - including the lateral orbitofrontal prefrontal cortex (lObfc) and rostral anterior cingulate cortex (rACC) - regulates emotional (and interoceptive) information. The hypothesis is that the non-emotional/exteroceptive regulatory system is more affected in ADHD, while the emotional/interoceptive regulatory system is more affected in EIP.

Aims: The aim of this study is to differentiate between dysfunctional emotional regulation processes related to emotional instability symptoms (when controlling for non-emotional ADHD-like symptoms), and dysfunctional non-emotional regulation processes related to ADHD symptoms (when controlling for emotional instability symptoms).

Procedure:

  • Participants: 30 young women from the Emotional Instability Unit at Child and Adolescent Psychiatry in Stockholm (Dialectic Behavioral Therapy unit ("DBT-teamet")), with traits of emotional instability and with varying levels of ADHD symptoms. 30 matched healthy controls.
  • Tests:

Behavioral task: Stop Signal Task: measures participant's ability to inhibit a motor response. Outcome measures are Stop Signal Reaction Time (SSRT) and Go Reaction Time (GoRT)

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • Undergone puberty
  • Right-handed
  • Monophasic contraceptives
  • Speak Swedish fluently
  • Additional inclusion criteria EIP patients:
  • ≥4/9 criteria of DSM-IV, measured by SCID-II interview

排除标准

  • Impaired vision > +/- 5 D or other vision problem (squinting or severe astigmatism)
  • BMI <17, BMI >35 due to possible hormonal disturbance
  • Some medical drugs: benzodiazepines, neuroleptics, mood stabilisers, central stimulants, other neuro pharmaceuticals. (SSRIs are ok)
  • Not suitable for MRI scan (metal implants or severe claustrophobia)
  • AQ-score >26
  • Alexithymia (≥52 in TAS20 questionnaire or poor score in facial recognition test (FEFA2));
  • Mental retardation (IQ <70 according to Ravens SPM)
  • Reading difficulties (reading speed >2 standard deviations slower than normal population of same age
  • Established addiction problems (nicotine ok)
  • Color blindness (>10 points on Ishihara-test)
  • Psychotic disorder (according to medical history, DAWBA, medical records)
  • Anorexia nervosa that has required hospital care
  • Bipolar disorder (according to DAWBA and medical records)
  • Neurological disease (according to medical history and medical records)
  • Endocrinological disease
  • Other disease, condition or treatment that may substantially affect cognition

结局指标

主要结局

Reaction times in Stroop task

时间窗: Acquired during fMRI scan

Stop Signal reaction times (SSRT) from Stop Signal Task (SST)

时间窗: Data necessary for estimation of SSRT acquired during fMRI scan

fMRI signal variations within patient group during Stroop task, depending on level of ADHD symptoms - in Stroop task

时间窗: Acquired during fMRI scan

BOLD signal Neutral and Emotional blocks, and for Congruent and Incongruent trials (order dependent)

Reaction times in MID task

时间窗: Acquired during fMRI scan

fMRI BOLD signal differences between groups - in Stroop task

时间窗: Acquired during fMRI scan

BOLD signal Neutral and Emotional blocks, and for Congruent and Incongruent trials (order dependent)

fMRI BOLD signal differences between groups - in Monetary Incentive Delay task (MID)

时间窗: Acquired during fMRI scan

BOLD signal during anticipation phase of different levels of reward, and BOLD signal during receipt/outcome phase of different levels of reward.

fMRI BOLD signal differences within patient group during MID task, depending on level of ADHD symptoms - in MID task

时间窗: Acquired during fMRI scan

BOLD signal during anticipation phase of different levels of reward, and BOLD signal during receipt/outcome phase of different levels of reward.

次要结局

  • STAI-T score(Acquired from questionnaire at first visit)
  • Barratt's impulsivity scale (BIS)(Acquired from questionnaire at first visit)
  • Motivation score(Acquired during MRI scan, on Day 2)
  • Brown-ADD score(Acquired from questionnaire at first visit)
  • Mood and Feelings questionnaire(Acquired from questionnaire at first visit)
  • Structural MRI data - volume(Acquired during MRI scan)
  • Structural MRI data - surface area(Acquired during MRI scan)
  • Functional Connectivity (FC)(Acquired during resting state MRI scan)
  • Fractional Anisotropy (FA) of white matter(Acquired during Diffusion Tensor Imaging (DTI) scan)
  • STAI-S score(Baseline, acquired from questionnaire Day 2)
  • Sleepiness score(Acquired during MRI scan, on Day 2)
  • Structural MRI data - thickness(Acquired during MRI scan)

研究者

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

Predrag Petrovic

MD, PhD, Associate Professor

Karolinska Institutet

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