Status:
COMPLETED
Quality Assurance of Administering Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD) - QUMEA
Lead Sponsor:
Medice Arzneimittel Pütter GmbH & Co KG
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Investigation of efficacy of high-dose extended-release Methylphenidate in adults with ADHD, compared with a placebo
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00730249
Start Date
September 1 2008
Last Update
January 13 2010
Active Locations (11)
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1
Praxis Johannes Fuhr
Bad Wildungen, Germany, 34537
2
Charité Campus Mitte, Station 155
Berlin, Germany, 10117
3
Gemeinschaftspraxis für Kinder- und Jugendpsychiatrie, Psychotherapie
Berlin, Germany, 10789
4
Universitätsklinik Bochum
Bochum, Germany, 44791