Adult Attention Deficit Hyperactivity Disorder MedDRA version: 8.1 Level: LLT Classification code 10003735 Term: Attention deficit-hyperactivity disorder
Conditions
Interventions
Trade Name: Strattera
Product Name: Strattera
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Atomoxetine
CAS Number: 83015263
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
University of Giessen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Actual diagnosis of ADHD according to DSM IV • Age 18 to 50 • Both sexes • Declaration of informed consent for all clinical measures • Normal IQ (Estimated by a short IQ test during the screening) • Normal ECG findings • Sufficient knowledge of the German language to follow instructions and training procedure • In- and out-patients • Consent to a highly effective birth control method (failure rate less than 1%) for female patients in childbearing years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Other psychiatric disorder according to DSM IV • Any neurological disorder • Tachykardia, hyperpiesia or very low blood pressure • Liver malfunctions • Contraindication for the usage of Atomoxetine as listed in the companies safety information • Intake of antibiotics, azol-antimycotics, antihistamines or antiarrhythmics • History of allergic reaction to Atomoxetine • Female patients who are pregnant or nursing • Other medication that affects the central nervous system • Paticipation in other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Verification of the effectiveness of behavioral therapy, pharmacological treatment with Atomoxetine (Strattera) and its combination on the attentional impairments of adults with attention deficit hyperactivity disorder using objective measurements as indicators of effectiveness.;Secondary Objective: Investigation of potential improvement of clinical symptoms, subjective experiences and compliance with a pharmacological treatment, a behavioral group program or the combination of both.;Primary end point(s): Completion of the full protocoll after 18 weeks | — |
Countries
Germany
Outcome results
None listed