An observational study in Attention Deficit Hyperactivity Disorder and Borderline Personality Disorder, sponsored by Simone Grimm. Completed at 1 site in Germany. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-01-03.
Sponsored by Simone Grimm · Observational
Among 63 studies in Attention Deficit Disorder with Hyperactivity with a site in Germany — 2 open to participants now, 2 under way, none of them phase 3. Attention Deficit Disorder with Hyperactivity · Germany.
Among the 63 studies in Attention Deficit Disorder with Hyperactivity with a site in Germany, this one is one of 4 that started in 2024, is one of 8 observational ones, and was the 59th registered.
1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 295 are open to participants now.
Browse Attention Deficit Disorder with Hyperactivity studies →2 of the 63 studies in Attention Deficit Disorder with Hyperactivity with a site in Germany are open now. Recruiting first, the newest first:
Prof. Dr. Frank Behrens · Sites in Germany
Ages 18–65
Bielefeld University · Sites in Germany
Ages 6–13
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 201 Attention Deficit Disorder with Hyperactivity studies recruiting now, 27 (13%) set no upper age limit and 169 (84%) stop at 75 or younger; 141 take children under 18; 55 take healthy volunteers.
This study: 18 Years to 45 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
63 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 5 · Phase 3 23 · Phase 4 8
First in 2000; this study’s year is marked. 4 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 20 is below the median of 127 across 329 observational studies indexed under Attention Deficit Disorder with Hyperactivity.
Median enrollment 150 across the 55 interventional studies, 434 across the 8 observational. Of the 52 that completed or were terminated, 20 (38%) have results posted.
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33 of 63 have an industry lead sponsor. The 10 most frequent:
Simone Grimm is the lead sponsor of 2 studies on the registry; none are open to participants now.
Simone Grimm has 1 study filed under Attention Deficit Disorder with Hyperactivity — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 63 studies in Attention Deficit Disorder with Hyperactivity with a site in Germany, from their registry updates:
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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).
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects deemed to be at significant risk of serious violence or suicide based on any one of the following:
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:
Any to undergo an MRI radiography (e.g. history of surgery involving metal implants), including but not limited the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: During asl on experimental day (visit number 2 (study day 1))
Correlation between BOLD signal during the 4-CSRTT and impulsivity scores on the BIS-11
Correlation between magnitude of BOLD signal during the 4-CSRTT and impulsivity scores on the BIS-11
Time frame: 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
Correlation between magnitude of BOLD signal during the SST and impulsivity scores on the BIS-11
Time frame: 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
Correlation between magnitude of BOLD signal during the 4-CSRTT and impulsivity scores on the S-UPPS
Time frame: 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 S-UPPS
Correlation between magnitude of BOLD signal during the SST and impulsivity scores on the S-UPPS
Time frame: 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))
Reaction times in ms
Reaction times in ms extracted from the in- scanner protocol log files
Time frame: During all tasks on experimental day (visit number 2 (study day 1))
Premature responses
Number of premature responses extracted from the in- scanner protocol log files
Time frame: During all tasks on experimental day (visit number 2 (study day 1))
Reaction times during the 4-CSRTT after stress induction
Task performance is measured based on the reaction times (RTs) for choices. Stress is induced using the Mannheim Multicomponent Stress Test (MMST).
Time frame: During the 4-CSRTT after stress is induced on experimental day (visit number 2 (study day 1))
Premature responses during the 4-CSRTT after stress induction
Task performance is measured based on the number of premature responses. Stress is induced using the Mannheim Multicomponent Stress Test (MMST).
Time frame: During the 4-CSRTT after stress is induced on experimental day (visit number 2 (study day 1))
Impulsive choice ratio during the 4-CSRTT after stress induction
Task performance is measured based on the impulsive choice ratio. Stress is induced using the Mannheim Multicomponent Stress Test (MMST).
Time frame: During the 4-CSRTT after stress is induced on experimental day (visit number 2 (study day 1))
Reaction times during the DDT after stress induction
Task performance is measured based on reaction times (RTs) for choices. Stress is induced using the Mannheim Multicomponent Stress Test (MMST).
Time frame: During the DDT after stress is induced on experimental day (visit number 2 (study day 1))
Premature responses during the DDT after stress induction
Task performance is measured based on the number of premature responses. Stress is induced using the Mannheim Multicomponent Stress Test (MMST).
Time frame: During the DDT after stress is induced on experimental day (visit number 2 (study day 1))
Correlation between BOLD signal and behavioral measures during 4-CSRTT
Correlation between magnitude of BOLD signal during 4-CSRTT and behavioral measures of the 4-CSRTT
Time frame: during the 4-CSRTT conducted in the scanner on experimental day (visit number 2 (study day 1))
Correlation between BOLD signal and behavioral measures during SST
Correlation between magnitude of BOLD signal during SST and behavioral measures of the SST
Time frame: during the SST conducted in the scanner on experimental day (visit number 2 (study day 1))
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2024 to primary completion in Oct 2024, 2 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Attention Deficit Disorder with Hyperactivity →
Simone Grimm