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Emotional and Non-emotional Regulation in Patients With Emotional Instability and ADHD

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ClinicalTrials.gov Identifier: NCT02797873
Recruitment Status : Unknown
Verified June 2016 by Predrag Petrovic, Karolinska Institutet.
Recruitment status was:  Not yet recruiting
First Posted : June 14, 2016
Last Update Posted : June 14, 2016
Sponsor:
Information provided by (Responsible Party):
Predrag Petrovic, Karolinska Institutet

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Emotional Instability Personality Disorder (Borderline Personality Disorder) Attention Deficit Hyperactivity Disorder Healthy Controls Other: fMRI - Stroop task Other: fMRI - MID task Behavioral: Stop Signal Task Other: SCID-II Other: SDQ Other: ASRS Other: AQ Other: TAS-20 Other: Raven's SPM Other: Reading ability Other: Ishihara's tests for colour deficiency Other: Additional questionnaire Other: Brown-ADD Other: MFQ Other: STAI-T Other: BIS Other: DAWBA Other: STAI-S Other: Sleepiness rating Other: Motivation rating Behavioral: FEFA2 Other: Structural T1 MRI scan Other: Structural T2 MRI scan Other: DTI MRI scan Other: Resting state MRI scan Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Emotional and Non-emotional Regulation in Patients With Emotional Instability Personality Disorder (EIP) and Attention Deficit Hyperactivity Disorder (ADHD) Symptoms
Study Start Date : August 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EIP

Patients from the DBT unit suffering from symptoms of Emotional Instability (n=30), with different levels of ADHD symptoms as assessed by questionnaires Brown-ADD, ASRS and SDQ.

Interventions:

  • fMRI - Stroop task
  • fMRI - MID task
  • Stop Signal task
  • Structural T1 MRI scan
  • Structural T2 MRI scan
  • DTI MRI scan
  • Resting state MRI scan
  • FEFA 2
  • SCID-II
  • SDQ
  • ASRS
  • AQ
  • TAS-20
  • Raven's SPM
  • Reading ability
  • Ishihara's tests for colour deficiency
  • Additional questionnaire
  • Brown-ADD
  • MFQ
  • STAI-T
  • BIS
  • DAWBA
  • STAI-S
  • Sleepiness rating x 6
  • Motivation rating x 6
Other: fMRI - Stroop task
2 x 10 minutes Stroop task (2 x 5 minutes emotional blocks, 2 x 5 minutes non-emotional blocks, order balanced across participants) performed during fMRI scan. See Detailed Study Description.

Other: fMRI - MID task
2 x 10 minutes MID task performed during fMRI scan. See Detailed Study Description.

Behavioral: Stop Signal Task
Performed at a computer at first visit, 10 minutes divided into 3 blocks. See Detailed Study Description.

Other: SCID-II
See Detailed Study Description.

Other: SDQ
See Detailed Study Description.

Other: ASRS
See Detailed Study Description.

Other: AQ
See Detailed Study Description.

Other: TAS-20
See Detailed Study Description.

Other: Raven's SPM
See Detailed Study Description.

Other: Reading ability
See Detailed Study Description.

Other: Ishihara's tests for colour deficiency
See Detailed Study Description.

Other: Additional questionnaire
including questions about somatic disease, current medication, BMI, smoking habits, first menstruation, last menstruation's first day, days without active oral contraceptive pill during last month, claustrophobia, vision impairment.

Other: Brown-ADD
See Detailed Study Description.

Other: MFQ
See Detailed Study Description.

Other: STAI-T
See Detailed Study Description.

Other: BIS
See Detailed Study Description.

Other: DAWBA
See Detailed Study Description.

Other: STAI-S
See Detailed Study Description.

Other: Sleepiness rating
Acquired 6 times while in MRI-scanner. See Detailed Study Description.

Other: Motivation rating
Acquired 6 times while in MRI-scanner. See Detailed Study Description.

Behavioral: FEFA2
Assessing ability to recognise emotional face, performed at a computer at first visit. See Detailed Study Description.

Other: Structural T1 MRI scan
See Detailed Study Description and Outcome Measures.

Other: Structural T2 MRI scan
See Detailed Study Description.

Other: DTI MRI scan
See Detailed Study Description and Outcome Measures.

Other: Resting state MRI scan
See Detailed Study Description and Outcome Measures.

Experimental: Healthy controls

Matched healthy controls (according to age, IQ and socio economic status) recruited from high schools in Stockholm area (n=30).

Interventions:

  • fMRI - Stroop task
  • fMRI - MID task
  • Stop Signal task
  • Structural T1 MRI scan
  • Structural T2 MRI scan
  • DTI MRI scan
  • Resting state MRI scan
  • FEFA 2
  • SCID-II
  • SDQ
  • ASRS
  • AQ
  • TAS-20
  • Raven's SPM
  • Reading ability
  • Ishihara's tests for colour deficiency
  • Additional questionnaire
  • Brown-ADD
  • MFQ
  • STAI-T
  • BIS
  • DAWBA
  • STAI-S
  • Sleepiness rating x 6
  • Motivation rating x 6
Other: fMRI - Stroop task
2 x 10 minutes Stroop task (2 x 5 minutes emotional blocks, 2 x 5 minutes non-emotional blocks, order balanced across participants) performed during fMRI scan. See Detailed Study Description.

Other: fMRI - MID task
2 x 10 minutes MID task performed during fMRI scan. See Detailed Study Description.

Behavioral: Stop Signal Task
Performed at a computer at first visit, 10 minutes divided into 3 blocks. See Detailed Study Description.

Other: SCID-II
See Detailed Study Description.

Other: SDQ
See Detailed Study Description.

Other: ASRS
See Detailed Study Description.

Other: AQ
See Detailed Study Description.

Other: TAS-20
See Detailed Study Description.

Other: Raven's SPM
See Detailed Study Description.

Other: Reading ability
See Detailed Study Description.

Other: Ishihara's tests for colour deficiency
See Detailed Study Description.

Other: Additional questionnaire
including questions about somatic disease, current medication, BMI, smoking habits, first menstruation, last menstruation's first day, days without active oral contraceptive pill during last month, claustrophobia, vision impairment.

Other: Brown-ADD
See Detailed Study Description.

Other: MFQ
See Detailed Study Description.

Other: STAI-T
See Detailed Study Description.

Other: BIS
See Detailed Study Description.

Other: DAWBA
See Detailed Study Description.

Other: STAI-S
See Detailed Study Description.

Other: Sleepiness rating
Acquired 6 times while in MRI-scanner. See Detailed Study Description.

Other: Motivation rating
Acquired 6 times while in MRI-scanner. See Detailed Study Description.

Behavioral: FEFA2
Assessing ability to recognise emotional face, performed at a computer at first visit. See Detailed Study Description.

Other: Structural T1 MRI scan
See Detailed Study Description and Outcome Measures.

Other: Structural T2 MRI scan
See Detailed Study Description.

Other: DTI MRI scan
See Detailed Study Description and Outcome Measures.

Other: Resting state MRI scan
See Detailed Study Description and Outcome Measures.




Primary Outcome Measures :
  1. fMRI BOLD signal differences between groups - in Stroop task [ Time Frame: Acquired during fMRI scan ]
    BOLD signal Neutral and Emotional blocks, and for Congruent and Incongruent trials (order dependent)

  2. fMRI signal variations within patient group during Stroop task, depending on level of ADHD symptoms - in Stroop task [ Time Frame: Acquired during fMRI scan ]
    BOLD signal Neutral and Emotional blocks, and for Congruent and Incongruent trials (order dependent)

  3. Reaction times in Stroop task [ Time Frame: Acquired during fMRI scan ]
  4. fMRI BOLD signal differences between groups - in Monetary Incentive Delay task (MID) [ Time Frame: 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.

  5. fMRI BOLD signal differences within patient group during MID task, depending on level of ADHD symptoms - in MID task [ Time Frame: 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.

  6. Reaction times in MID task [ Time Frame: Acquired during fMRI scan ]
  7. Stop Signal reaction times (SSRT) from Stop Signal Task (SST) [ Time Frame: Data necessary for estimation of SSRT acquired during fMRI scan ]

Secondary Outcome Measures :
  1. Brown-ADD score [ Time Frame: Acquired from questionnaire at first visit ]
  2. Mood and Feelings questionnaire [ Time Frame: Acquired from questionnaire at first visit ]
    dimensional measurement of depressive symptoms

  3. STAI-T score [ Time Frame: Acquired from questionnaire at first visit ]
    Measuring anxiety trait level

  4. Barratt's impulsivity scale (BIS) [ Time Frame: Acquired from questionnaire at first visit ]
  5. STAI-S score [ Time Frame: Baseline, acquired from questionnaire Day 2 ]
    Measuring anxiety state level

  6. Sleepiness score [ Time Frame: Acquired during MRI scan, on Day 2 ]
    Acquired 6 times in MRI scanner as follows: 1) Before first Stroop session. 2) Between Stroop session 1 and 2. 3) After Stroop session 2. 4) Before first MID session. 5) Between MID session 1 and 2. 6) After MID session 2.

  7. Motivation score [ Time Frame: Acquired during MRI scan, on Day 2 ]
    Acquired 6 times in MRI scanner as follows: 1) Before first Stroop session. 2) Between Stroop session 1 and 2. 3) After Stroop session 2. 4) Before first MID session. 5) Between MID session 1 and 2. 6) After MID session 2.

  8. Structural MRI data - volume [ Time Frame: Acquired during MRI scan ]
  9. Structural MRI data - surface area [ Time Frame: Acquired during MRI scan ]
  10. Structural MRI data - thickness [ Time Frame: Acquired during MRI scan ]
  11. Functional Connectivity (FC) [ Time Frame: Acquired during resting state MRI scan ]
    Measuring the FC value between ROIs defined in hypothesis to determine strength of connectivity between these different brain regions.

  12. Fractional Anisotropy (FA) of white matter [ Time Frame: Acquired during Diffusion Tensor Imaging (DTI) scan ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797873


Contacts
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Contact: Predrag Petrovic predrag.petrovic@ki.se

Sponsors and Collaborators
Karolinska Institutet

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Responsible Party: Predrag Petrovic, MD, PhD, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02797873     History of Changes
Other Study ID Numbers: 2015/127-31/1_EI_ADHD
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
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Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Personality Disorders
Borderline Personality Disorder
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms