F90.0
Conditions
Interventions
Group 1: Participants with emotionally dysregulated presentation of ADHD form the observation group (BG). On the first day of the study, after enrolment and checking the inclusion and exclusion criter
Sponsors
Universität Leipzig
Eligibility
Sex/Gender
All
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: Signed informed consent for study participation, Confirmed primary diagnosis of adult ADHD according to DSM-5, Medication naïve or with previous use of psychostimulants, antidepressants, or atomoxetine after a 4-week washout period of the respective medication, Ability to perform a computerized neurobiological test battery, Sufficient understanding of the German language, Consent according to §7 Abs.2 Nr.15 of the GCP regulation about the passing on of the pseudonymized data in the context of the documentation and notification duties according to §12 and §13 GCP regulation.
Exclusion criteria
Exclusion criteria: Lack of capacity to consent, Acute suicidality, Current depressive disorder, single or recurrent episode, Emotionally unstable personality disorder, borderline type, Schizophrenia spectrum and other psychotic disorders, Bipolar and related disorders, Alcohol and/or drug dependence as a primary diagnosis and/or a positive urine drug screen, Mental disorders with a known physiological etiology, Intelligence deficits, Treatment with a neurostimulation procedure within the past 6 months, Contraindications to PET or MRI scan, Severe somatic or neurological comorbidity or unstable clinical condition within the past 12 months that affects cognitive performance, Caregiving and/or institutionalization, Pregnancy or positive urine pregnancy test, lactation. Lack of compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to test the hypothesis that individuals with ADHD of the emotionally dysregulated presentation type differ in NET availability from individuals with other presentation types of ADHD. To determine central NET availability, acquired PET data will be reconstructed and corrected in a standardized manner. NET distribution volume (DVR)/binding potential (BP) images will be generated from the PET data using reference tissue models. Volumes of interest (VOI) are defined in the DVR images after coregistration of the parametric DVR images with the individual 3D MRI dataset, and the regional DVRs are determined. In addition to VOI-based analysis, other statistical evaluation methods are used, such as | — |
Secondary
| Measure | Time frame |
|---|---|
| In particular, NET availability in brain regions relevant for response inhibition and impulse modulation will be compared between the observation groups. Furthermore, it will be investigated whether NET availability correlates with ADHD symptom severity, neuropsychological and neurophysiological parameters, and functional networks. a) DMS-ADHS total score and subscale scores from Conners’ Adult ADHD Rating Scales (CAARS) b) Clinical Global Impressions Scale of Severity score (CGI-S) c) Sum scores of functional level questionnaire categories d) Adult ADHD Quality of Life Questionnaire (AAQoL) total and subscale scores e) Trail Making Test Part B (TMT-B) performance times and error rates f) Mean, median and range of reaction times as well as correct responses, errors, omissions and missings of selected subtests (Working Memory, Divided Attention, Go/NoGo, Flexibility, Visual Scanning) of the Test Battery for Attention (TAP) g) the mean vigilance level and the arousal stability score of the resting EEG as well as the latencies and amplitudes of the event-related potential. | — |
Countries
Germany
Contacts
Public ContactNicole Mauche
Universität Leipzig, Medizinische Fakultät, Klinik und Poliklinik für Psychiatrie und Psychotherapie
Outcome results
None listed