Investigation of efficacy of high-dose extended-release Methylphenidate in adults with ADHD, compared with a placebo

Inclusion Criteria:

• patient treated as out-patient
• score of 85 or greater in IQ-test (MWT-B)
• diagnosis of ADHD according ADHS-CL (DSM IV) and WRAADDS > 35 points
• ADHD symptoms have existed since childhood (WURS-k >= 30)
• Body Mass Index >= 20 and body weight < 130 kg
• willing to eat breakfast and lunch
• patient is willing and able to come to the observation appointments
• written consent of the patient to participate in the study

Exclusion Criteria:

• treatment with psychostimulants in the past two weeks before screening
• shift work or night work
• alcohol, medication or drug dependency in the past six months or manifest drug abuse
• diagnosis of a psychosis (SKID-I)
• epileptic attacks in the past
• EEG result which suggests epilepsy
• acute depressive episode according to ICD-10 F32.2 and ICD-10 F32.3 (Beck-Depression-Inventory > 18)
• Illness with schizophrenic symptoms (SKID-I)
• acute manic episode, bipolar disorder(SKID-I)
• diagnosis of a tic disorder
• acute anorexia
• acute prominent panic disorder and generalised anxiety (SKID-I)
• clinically relevant kidney disorders
• creatinine > 1,5 x upper norm-range
• clinically relevant liver disorder
• SGOT and/or SGPT > 2 x upper norm-range
• pathological ECG-finding
• QTc > 450 msec in male, QTc > 470 msec in female
• high blood pressure (anamnesis or blood pressure > 140/90 mm Hg at screening)
• known acclusive arterial disease
• angina pectoris (anamnesis or ECG-finding)
• cardiac arrhythmias (anamnesis or ECG-finding)
• KHK (anamnesis or ECG-finding)
• post heart-attack status (anamnesis or ECG-finding)
• post stroke status
• known elevated intra-ocular pressure
• known enlarged prostates
• latent and manifest hyperthyreosis
• TSH < lower norm-range
• patient with a terminal disease (e.g. cancer)
• participation in a clinical study within the past 30 days
• participation in this study at an earlier point in time
• simultaneous participation in another clinical trial
• women of child-bearing age without adequate contraception (contraceptives, intrauterine device , no sexual intercourse)
• pregnancy (positive pregnancy test) or lactation period