A parallel randomized double-blind sham-controlled multicentre trial of transcranial direct current stimulation (tDCS) in adult attention deficit hyperactivity disorder (ADHD)

Not Applicable

Recruiting

Conditions: MedDRA - Attention deficit hyperactivity disorder
F90.0
Disturbance of activity and attention

Registration Number: DRKS00028148

Lead Sponsor: niversität Leipzig

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 250

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

? 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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.<br>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<br>2) Reaction time, variability, omission and action errors assessed by Continuous Performance Test (CPT) on Visit 1, 5, 14 and 90<br>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<br>4) Symptomatic distress assessed by Symptom Checklist-90-Revised (SCL-90-S) on Visit 1, 5, 7, 14, 28, 56 and 90<br>5) Sleep quality and disturbance assessed by Pittsburgh Sleep Quality Index (PSQI) on Visit 1, 5, 7, 14, 28, 56 and 90