Quality Assurance of Administering Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD) - QUMEA

Launched by MEDICE ARZNEIMITTEL PÜTTER GMBH & CO KG · Aug 7, 2008

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Gender

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Eligibility criteria

• 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