Performance and FMRI BOLD Signal Changes in Impulsive Patients

Last updated: January 2, 2025
Sponsor: Simone Grimm
Overall Status: Completed

Phase

N/A

Condition

Attention Deficit/hyperactivity Disorder (Adhd - Adults)

Schizotypal Personality Disorder (Spd)

Autism Spectrum Disorder (Asd)

Treatment

N/A

Clinical Study ID

NCT06491160
MSBC004
  • Ages 18-45
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. meet current DSM-5 criteria for ADHD or BPD as a primary diagnosis as assessed bySCID and SCID-PD

  2. between 18 and 45 years, inclusive

  3. BIS-11 score of ≥ 70

  4. completely fluent German speaker who, in the opinion of the Investigator, is capableof completing the fMRI and behavioral tasks

  5. must have signed the informed consent form prior to the first study-relatedprocedure indicating they understand the purpose of, and procedures required for thestudy and are willing to participate in the study.

Exclusion

Exclusion Criteria:

  1. Lifetime diagnosis of schizophrenia, schizoaffective disorder, schizophreniformdisorder, bipolar I or II disorder, delusional disorder, or autism spectrum disorderas confirmed by the SCID at screening visit

  2. Moderate or severe substance use disorder within the last 6 months.

  3. Any other psychiatric disorder that is not currently stable in symptoms andtreatment. Stable is defined as have no significant changes in symptom acuity ormedication treatment in the 3 months prior to enrollment

  4. Positive results on a urine drug screen or alcohol breath test, or any signs orsymptoms of acute intoxication at screening or enrollment visit

  5. A female subject with a positive pregnancy test at screening or enrollment visit

  6. Unstable medical condition, history of seizure disorders, stroke, brain tumor, orany other major neurological illness

  7. Subjects deemed to be at significant risk of serious violence or suicide based onany one of the following:

  • Significant risk of committing violent acts, homicide, serious self-harm, orsuicide based on history, routine psychiatric status examination, or accordingto the investigator's experience OR

  • Any suicide attempt in the past 6 months (i.e. actual attempt, interruptedattempt, aborted attempt) prior to enrollment OR

  • Any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity RatingScale (C-SSRS) in the past 6 months prior to enrollment

  1. Subjects not expected to comply with the protocol requirements or not expected tocomplete the trial as scheduled (that, in the investigator's opinion, makes thesubject an unreliable trial subject)

  2. Concomitant use of restricted psychotropic medication. All restricted psychotropicmedications must be washed out at least 5 half-lives prior to enrollment (includingADHD medications such as amphetamine or methylphenidate derivates). Allowedmedications must be stable in agent, dose, and frequency for > 3 month prior toenrollment:

  • a single antidepressant of the Selective Serotonin Reuptake Inhibitor (SSRI) orSerotonin-Noradrenaline Reuptake Inhibitor (SNRI) class

  • A single second-generation antipsychotic at a low dose (1 thorazine doseequivalent or less, which translates to ≤ 2 mg/day for risperidone, 5 mg/dayfor olanzapine, 75 mg/day for quetiapine, 60 mg/day for ziprasidone, and 7.5mg/day for aripiprazole)

  • Permitted sleep medications must be nightly scheduled medications (not PRN) andmay include non-benzodiazepines, antihistamines, melatonin, trazodone, low dosedoxepin (≤ 50mg), and low dose quetiapine (≤75mg qhs).

  1. Any contraindication to undergo an MRI radiography (e.g. history of surgeryinvolving metal implants), including but not limited the following:
  • A planned medical treatment within the study period that might interfere withthe study procedures

  • Subjects who have undergone operations to the head

  • Subjects with significant hearing impairments which, in the opinion of theinvestigator, may interfere with the performance of fMRI tasks

  • Subjects with a significant visual impairment including color blindness, orhistory of ocular treatment including corrective laser eye surgery, or ongoingcondition, which in the opinion of the investigator may interfere with theperformance of the behavioral or fMRI tasks

  1. Subject is a staff member or the relative of a staff member or is in a subordinaterelationship with the Investigator

  2. Signs or symptoms of Post-Covid disease

  3. Inability or unwillingness to comply with study procedures, including studyprohibitions and restrictions

  4. Any condition for which, in the opinion of the investigator, participation would notbe in the best interest of the subject (e.g., compromise the well-being) or thatcould prevent, limit, or confound the protocol-specified assessments

  5. Vulnerable subject who lives in an institution on court or authority order

  6. Participation in another clinical trial.

Study Design

Total Participants: 20
Study Start date:
August 06, 2024
Estimated Completion Date:
October 30, 2024

Study 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.

Connect with a study center

  • Charité Research Organisation GmbH

    Berlin,
    Germany

    Site Not Available

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