In vivo imaging and quantification of central norepinephrine transporters (NET) by [11C]MRB positron emission tomography (PET)/magnetic resonance imaging (MRI) in adult patients with attention-deficit/hyperactivity disorder (ADHD) and emotional dysregulation (ED)

Conditions: F90.0
Disturbance of activity and attention

Registration Number: DRKS00032396

Lead Sponsor: niversität Leipzig

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 40

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

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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures