Attention Deficit Hyperactivity DisorderNCT06491160
Performance and FMRI BOLD Signal Changes in Impulsive Patients
An observational study of Attention Deficit Hyperactivity Disorder and Borderline Personality Disorder, run by Simone Grimm at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Borderline Personality Disorder
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 6 Aug 2024to 30 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 26Show fewer
- 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).
- Any contraindication to undergo an MRI radiography (e.g. history of surgery involving metal implants), including but not limited the following:
- A planned medical treatment within the study period that might interfere with the study procedures
- Subjects who have undergone operations to the head
- Subjects with significant hearing impairments which, in the opinion of the investigator, may interfere with the performance of fMRI tasks
- Subjects with a significant visual impairment including color blindness, or history of ocular treatment including corrective laser eye surgery, or ongoing condition, which in the opinion of the investigator may interfere with the performance of the behavioral or fMRI tasks
- Subject is a staff member or the relative of a staff member or is in a subordinate relationship with the Investigator
- Signs or symptoms of Post-Covid disease
- Inability or unwillingness to comply with study procedures, including study prohibitions and restrictions
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Vulnerable subject who lives in an institution on court or authority order
- Participation in another clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trial to Explore Performance and FMRI BOLD Signal Changes During Impulsivity Tasks in Impulsive Patients with Attention Deficit Hyperactivity Disorder and Borderline Personality Disorder
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).
Read the detailed description
It is planned to conduct a clinical trial to test pharmacodynamic effects of a new drug under development for impulsivity including patients with ADHD or BPD. For the preparation of this planned trial, a preceding study will be conducted. The results of this preceding study will be needed to prepare and plan the upcoming proof-of-clinical-principle-study regarding behavioral effects, involved brain regions, effect sizes, patient experience, and task design. Testing and optimizing the study procedures in advance in this preceding study will help to define the objectives and endpoints of the planned pharmacodynamic trial.
- Keywords
- Attention Deficit Hyperactivity Disorder, Borderline Personality Disorder, Functional Brain Changes, BOLD responses
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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)
Measured: During asl on experimental day (visit number 2 (study day 1))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start6 Aug 2024
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simone Grimm
- Sponsor type
- University, hospital or other
- Collaborators
- Charité Research Organisation GmbH, Boehringer Ingelheim
- Responsible party
- Sponsor-investigator, Simone Grimm, Medical School Berlin
- Investigators
- Christian Keicher, Dr. med., Principal investigator, Charité Research Organisation, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491160
- Sponsor's protocol ID
- MSBC004
- Status last verified
- Jul 2024
- First submitted
- 6 Jun 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Explore Performance and FMRI BOLD Signal Changes During Impulsivity Tasks in Impulsive Patients with Attention Deficit Hyperactivity Disorder and Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT06491160
- Acronym / sponsor ID
- MSBC004
- Keywords
- Attention Deficit Hyperactivity Disorder, Borderline Personality Disorder, Functional Brain Changes, BOLD responses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Simone GrimmUniversity, hospital or other
- Collaborators
- Charité Research Organisation GmbH, Boehringer Ingelheim
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
It is planned to conduct a clinical trial to test pharmacodynamic effects of a new drug under development for impulsivity including patients with ADHD or BPD. For the preparation of this planned trial, a preceding study will be conducted. The results of this preceding study will be needed to prepare and plan the upcoming proof-of-clinical-principle-study regarding behavioral effects, involved brain regions, effect sizes, patient experience, and task design. Testing and optimizing the study procedures in advance in this preceding study will help to define the objectives and endpoints of the planned pharmacodynamic trial.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Average percent BOLD signal change during the 4-Choice Serial-Reaction Time Task (4-CSRTT)
Time frame: During the 4-CSRTT on experimental day (visit number 2 (study day 1))
Blood oxygen level dependent (BOLD) fMRI signal changes will be analyzed to identify brain regions with significant activation during the 4-CSRTT
Average percent BOLD signal change during the Stop Signal Task (SST)
Time frame: During the SST on experimental day (visit number 2 (study day 1))
Blood oxygen level dependent (BOLD) fMRI signal changes will be analyzed to identify brain regions with significant activation during the SST
Average percent BOLD signal change during resting state
Time frame: During resting state on experimental day (visit number 2 (study day 1))
Blood oxygen level dependent (BOLD) fMRI signal magnitude and BOLD signal standard deviation during resting state
Assessment of brain perfusion
Time frame: During asl on experimental day (visit number 2 (study day 1))
Change in relative and absolute cerebral blood flow are measured through Arterial Spin Labeling (ASL)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Keicher, Dr. med. principal investigator
Charité Research Organisation, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder and Borderline Personality Disorder, run by Simone Grimm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average percent BOLD signal change during the 4-Choice Serial-Reaction Time Task (4-CSRTT) (time frame: During the 4-CSRTT on experimental day (visit number 2 (study day 1))). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.