F90
Conditions
Interventions
Group 1: Group 1: Unmedicated participants with ADHD are examined multimodally using PET, interviews, questionnaires, neuropsychological tests, experimental paradigms, blood analyses, and MRI (two exa
Sponsors
Klinik und Poliklinik für Nuklearmedizin
Eligibility
Sex/Gender
All
Age
21 Years to 40 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for all study participants: - Age between 21 and 40 years; fulfillment of all ethical and legal requirements listed in the study protocol Additional inclusion criteria for study participants with ADHD: - DSM-5 diagnoses for ADHD, predominantly hyperactive-impulsive or combined presentation - Age of onset in childhood, symptom onset in early to middle childhood - Group 1: Drug-free for at least 6 months from all stimulants, including methylphenidate, amfetamine and lisdexamfetamine, atomoxetine and guanfacine (for drugs approved only in childhood and adolescence: for off-label use) - Group 2: Stable treatment with methylphenidate for at least the last 3 months (monotherapy)
Exclusion criteria
Exclusion criteria: Exclusion criteria for all study participants: - History of head injury that has resulted in brain damage - History of neurological, endocrine or cardiovascular disorders - Current or recent (within the last six months) ICD-10 diagnosis of F0x, F1x, F2x, F3x, F4x, F5x - History of ICD-10 diagnoses F0x, F2x, F3x, F6x, F8x - Use of all psychotropic drugs within the last 6 months except methylphenidate for participants with ADHD in group 2 - Current or recent (within the last month) recreational use of illicit substances according to the Heidelberg Drug Questionnaires - Recent (within the last three months) THC use as determined by hair analysis (0.02 ng/mg cut-off) - Positive result in a THC urine test that can detect the THC metabolite THC-COOH for up to 30 days (18 ng/ml cut-off) - Positive result in a multi-field drug test to detect the following substances: Morphine/heroin (opiates) (300 ng/ml cut-off), amphetamines (300 ng/ml cut-off), cocaine (300 ng/ml cut-off), methamphetamines (300 ng/ml cut-off), benzodiazepines (100 ng/ml cut-off), barbiturates (300 ng/ml cut-off), tricyclic antidepressants (300 ng/ml cut-off), methadone (300 ng/ml cut-off), MDMA/XTC (ecstasy) (500 ng/ml cut-off) - Pregnancy or breastfeeding - Contraindications to the safety of MRI, including the presence of metal plates, pins, bridges, or other devices
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the distribution volume VT of the PET tracer [18F]MK-9470 as a measure of CB1 receptor availability in the striatum (examination date 2). | — |
Secondary
| Measure | Time frame |
|---|---|
| Sekundary outcome measures include: - ADHD symptoms (WURS-k, ADHD-SR, CAARS-S:L, WRAADDS), impulsivity (BIS-11, UPPS), substance use (HDB, AUDIT, Fagerström), intelligence (MWT-B) using online questionnaires (before examination date 1) - Impulse control using structured interviews (M.I.N.I., IDA-R), Qb test, experimental paradigms (stop signal, delay discounting) (examination date 1) - Structural MRI and resting-state fMRI (examination date 1) - Concentration of endocannabinoids (AEA, 2-AG) and related lipids (AA, PEA, OEA) in blood (examination date 2) - Blood samples for CNR1 genotyping (examination date 2) - Distribution volume VT in cortico-striatal brain regions using [18F]MK-9470-PET (examination date 2) | — |
Countries
Germany
Contacts
Public ContactIsabelle Miederer
Klinik und Poliklinik für Nuklearmedizin
Outcome results
None listed