Quality Assurance of Administering Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD) - QUMEA
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- Drug: Placebo
- Registration Number
- NCT00730249
- Lead Sponsor
- Medice Arzneimittel Pütter GmbH & Co KG
- Brief Summary
Investigation of efficacy of high-dose extended-release Methylphenidate in adults with ADHD, compared with a placebo
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo - 1 methylphenidate hydrochloride -
- Primary Outcome Measures
Name Time Method Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) in last study-week (Placebo vs. Verum, double-blind phase, week 6) 20 weeks
- Secondary Outcome Measures
Name Time Method CAARS-Self-Report: Long Version (CAARS-S:L) 20 weeks
Trial Locations
- Locations (11)
Charité Campus Mitte, Station 155
🇩🇪Berlin, Germany
Universitätsklinik Bochum
🇩🇪Bochum, Germany
Praxis Johannes Fuhr
🇩🇪Bad Wildungen, Germany
Gemeinschaftspraxis für Kinder- und Jugendpsychiatrie, Psychotherapie
🇩🇪Berlin, Germany
Universitätsklinikum Freiburg, Abteilung für Psychiatrie und Psychotherapie
🇩🇪Freiburg, Germany
Universitäts-Klinik Eppendorf,
🇩🇪Hamburg, Germany
Praxis Dr. Heinrich Goossens-Merkt
🇩🇪Hamburg, Germany
Universität des Saarlandes, Institut für gerichtliche Psychiatrie
🇩🇪Homburg, Germany
Praxis Thomas Wirth
🇩🇪Ludwigsburg, Germany
Zentralinstitut für seelische Gesundheit
🇩🇪Mannheim, Germany
Medizinisches Studienzentrum Würzburg
🇩🇪Würzburg, Germany