Phase
Condition
Attention Deficit/hyperactivity Disorder (Adhd - Adults)
Schizotypal Personality Disorder (Spd)
Autism Spectrum Disorder (Asd)
Treatment
N/AClinical Study ID
Ages 18-45 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
meet current DSM-5 criteria for ADHD or BPD as a primary diagnosis as assessed bySCID 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 capableof completing the fMRI and behavioral tasks
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:
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
Moderate or severe substance use disorder within the last 6 months.
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
Positive results on a urine drug screen or alcohol breath test, or any signs orsymptoms 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, orany other major neurological illness
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
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)
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).
- 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
Subject is a staff member or the relative of a staff member or is in a subordinaterelationship with the Investigator
Signs or symptoms of Post-Covid disease
Inability or unwillingness to comply with study procedures, including studyprohibitions and restrictions
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
Vulnerable subject who lives in an institution on court or authority order
Participation in another clinical trial.
Study Design
Study Description
Connect with a study center
Charité Research Organisation GmbH
Berlin,
GermanySite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.