MedDRA - Attention deficit hyperactivity disorder F90.0
Conditions
Interventions
Group 1: Experimental intervention: Five 21-min sessions of bifrontal tDCS with the anode over right dorsolateral prefrontal cortex (rDLPFC, F4) and the cathode over the left DLPFC (F3)
for 5 consecutive days over the course of one week.
Group 2: Control intervention: Sham-stimulation with identical electrode placement and identical timely regimen as in experimental intervention.
Bot
Sponsors
Universität Leipzig
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: ? German speaking patients with primary DSM-5 diagnosis of ADHD ? Written informed consent ? Age >= 18 and <=65 years ? If treated with ADHD-specific medication, no change within the last 3 months before randomization
Exclusion criteria
Exclusion criteria: ? Acute risk for suicide ? Acute severe depressive episode ? Other severe psychiatric disorders as primary clinical problem (e.g., persistent depressive disorder, psychotic symptoms, bipolar disorder, schizoaffective disorder, schizophrenia, psychosis, Borderline personality disorder) ? Current alcohol use disorder or substance use disorder except for nicotine as primary clinical problem and/or a urine drug screening is positive ? Change in ADHD-specific medication/s planned before assessment of the primary endpoint ? other psychotropic medication: current or during wash-out period ? Severe somatic comorbidity ? Severe neurological comorbidities ? Contraindications for tDCS intervention ? Fertile women without appropriate contraceptive measures ? Participation in other interventional trials ? Patients under legal supervision or guardianship ? Suspected lack of compliance ? Pregnant or nursing women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective is to test the hypothesis that tDCS is effective in reducing ADHD symptoms with persisting benefits for at least 2 weeks after the end of stimulation and superior to sham-stimulation, determined by DSM-IV ADHD total score of the Conners’ Adult ADHD Rating Scales (German self-report screening form; CAARS-S-SR) 14 days post intervention (on Visit 7=primary endpoint) | — |
Secondary
| Measure | Time frame |
|---|---|
| Further characteristics often reported in ADHD patients is tested, e.g. improvement in sustained attention, everyday activities, psychological distress, as well as quality of sleep. 1) CAARS-S-SR DSM-IV scales: inattentive symptoms (DSM-IN) and hyperactive-impulsive symptoms (DSM-HY/I) on Visit 1, 5, 7, 14, 28, 56 and 90 2) Reaction time, variability, omission and action errors assessed by Continuous Performance Test (CPT) on Visit 1, 5, 14 and 90 3) ADHD-specific quality of life assessed by Adult ADHD Quality-of-Life Scale Questionnaire (AAQoL) on Visit 1, 5, 7, 14, 28, 56 and 90 4) Symptomatic distress assessed by Symptom Checklist-90-Revised (SCL-90-S) on Visit 1, 5, 7, 14, 28, 56 and 90 5) Sleep quality and disturbance assessed by Pittsburgh Sleep Quality Index (PSQI) on Visit 1, 5, 7, 14, 28, 56 and 90 | — |
Countries
Germany
Contacts
Public ContactMaria Strauß
Universitätsklinikum Leipzig AöR Department für Psychische Gesundheit Klinik und Poliklinik für Psychiatrie und Psychotherapie
Outcome results
None listed