Performance and FMRI BOLD Signal Changes in Impulsive Patients

NCT06491160 | Completed

• 1 other identifier: MSBC004
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a preceding study conducted to validate the methodology for assessing impulsivity by tasks and task-based fMRI measurements in patients with Attention Deficit Hyperactivity Disorder (ADHD) or Borderline Personality Disorder (BPD).

Conditions

Attention Deficit Hyperactivity Disorder; Borderline Personality Disorder

Keywords

Attention Deficit Hyperactivity Disorder; Borderline Personality Disorder; Functional Brain Changes; BOLD responses

Outcome Measures

Primary Outcomes (4)

• Average percent BOLD signal change during the 4-Choice Serial-Reaction Time Task (4-CSRTT)

  Blood oxygen level dependent (BOLD) fMRI signal changes will be analyzed to identify brain regions with significant activation during the 4-CSRTT

  During the 4-CSRTT on experimental day (visit number 2 (study day 1))

• Average percent BOLD signal change during the Stop Signal Task (SST)

  Blood oxygen level dependent (BOLD) fMRI signal changes will be analyzed to identify brain regions with significant activation during the SST

  During the SST on experimental day (visit number 2 (study day 1))

• Average percent BOLD signal change during resting state

  Blood oxygen level dependent (BOLD) fMRI signal magnitude and BOLD signal standard deviation during resting state

  During resting state on experimental day (visit number 2 (study day 1))

• Assessment of brain perfusion

  Change in relative and absolute cerebral blood flow are measured through Arterial Spin Labeling (ASL)

  During asl on experimental day (visit number 2 (study day 1))

Other Outcomes (13)

• Correlation between BOLD signal during the 4-CSRTT and impulsivity scores on the BIS-11

  Impulsivity scores were assessed on the screening day (visit number 1 (study days -28 to -1)), while BOLD signal changes during the 4-CSRTT were measured on the experimental day (visit number 2 (study day 1))

• Correlation between BOLD signal during the SST and impulsivity scores on the BIS-11

  Impulsivity scores were assessed on the screening day (visit number 1 (study days -28 to -1)), while BOLD signal changes during the SST were measured on the experimental day (visit number 2 (study day 1))

• Correlation between BOLD signal during the 4-CSRTT and impulsivity scores on the S-UPPS

  Impulsivity scores were assessed on the screening day (visit number 1 (study days -28 to -1)), while BOLD signal changes during the 4-CSRTT were measured on the experimental day (visit number 2 (study day 1))

Study Arms (2)

Attention Deficit Hyperactivity Disorder

Subjects eligible for enrolment in this study must the following criteria: 1. meet current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for ADHD as a primary diagnosis as assessed by the Structured Clinical Interview for DSM Disorders (SCID) and the Structured Clinical Interview for DSM Personality Disorders (SCID-PD) 2. between 18 and 45 years, inclusive 3. BIS-11 score of ≥ 70

Borderline Personality Disorder

Subjects eligible for enrolment in this study must meet all of the following criteria: 1. meet current DSM-5 criteria for BPD as a primary diagnosis as assessed by SCID and SCID-PD 2. between 18 and 45 years, inclusive 3. BIS-11 score of ≥ 70

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study population includes individuals diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) and with Borderline Personality Disorder (BPD). Subjects must meet current DSM-5 criteria for ADHD or BPD as a primary diagnosis as assessed by SCID and SCID-PD. Subjects must score higher than 70 on the Barratt Impulsiveness Scale (BIS) to be included in the study.

You may qualify if:

• meet current DSM-5 criteria for ADHD or BPD as a primary diagnosis as assessed by SCID and SCID-PD
• between 18 and 45 years, inclusive
• BIS-11 score of ≥ 70
• completely fluent German speaker who, in the opinion of the Investigator, is capable of completing the fMRI and behavioral tasks
• must have signed the informed consent form prior to the first study-related procedure indicating they understand the purpose of, and procedures required for the study and are willing to participate in the study.

You may not qualify if:

• Lifetime diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I or II disorder, delusional disorder, or autism spectrum disorder as confirmed by the SCID at screening visit
• Moderate or severe substance use disorder within the last 6 months.
• Any other psychiatric disorder that is not currently stable in symptoms and treatment. Stable is defined as have no significant changes in symptom acuity or medication treatment in the 3 months prior to enrollment
• Positive results on a urine drug screen or alcohol breath test, or any signs or symptoms of acute intoxication at screening or enrollment visit
• A female subject with a positive pregnancy test at screening or enrollment visit
• Unstable medical condition, history of seizure disorders, stroke, brain tumor, or any other major neurological illness
• Subjects deemed to be at significant risk of serious violence or suicide based on any one of the following:
• Significant risk of committing violent acts, homicide, serious self-harm, or suicide based on history, routine psychiatric status examination, or according to the investigator's experience OR
• Any suicide attempt in the past 6 months (i.e. actual attempt, interrupted attempt, aborted attempt) prior to enrollment OR
• Any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) in the past 6 months prior to enrollment
• Subjects not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (that, in the investigator's opinion, makes the subject an unreliable trial subject)
• Concomitant use of restricted psychotropic medication. All restricted psychotropic medications must be washed out at least 5 half-lives prior to enrollment (including ADHD medications such as amphetamine or methylphenidate derivates). Allowed medications must be stable in agent, dose, and frequency for \> 3 month prior to enrollment:
• a single antidepressant of the Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin-Noradrenaline Reuptake Inhibitor (SNRI) class
• A single second-generation antipsychotic at a low dose (1 thorazine dose equivalent or less, which translates to ≤ 2 mg/day for risperidone, 5 mg/day for olanzapine, 75 mg/day for quetiapine, 60 mg/day for ziprasidone, and 7.5 mg/day for aripiprazole)
• Permitted sleep medications must be nightly scheduled medications (not PRN) and may include non-benzodiazepines, antihistamines, melatonin, trazodone, low dose doxepin (≤ 50mg), and low dose quetiapine (≤75mg qhs).

Sponsors & Collaborators

• Simone Grimm: lead
• Charité Research Organisation GmbH: collaborator
• Boehringer Ingelheim: collaborator

Study Sites (1)

Charité Research Organisation GmbH

Berlin, Germany

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Personality Disorders

Study Officials

• Christian Keicher, Dr. med.

  Charité Research Organisation, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. habil.

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: July 8, 2024
• Study Start: August 6, 2024
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: January 3, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)