Quality Assurance of Administering Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD) - QUMEA
Information source: Medice Arzneimittel Pütter GmbH & Co KG
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Hyperactivity Disorder
Intervention: methylphenidate hydrochloride (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Medice Arzneimittel Pütter GmbH & Co KG Official(s) and/or principal investigator(s):
Roland Fischer, Dr., Study Chair, Affiliation: Medice Arzneimittel Pütter GmbH & Co KG
Michael Rösler, Prof. Dr., Study Director, Affiliation: Universität des Saarlandes, Institut für gerichtliche Psychiatrie
Overall contact:
Michael Rösler, Prof. Dr., Phone: +49 681 302
Summary
Investigation of efficacy of high-dose extended-release Methylphenidate in adults with ADHD,
compared with a placebo
Clinical Details
Official title: Quality Assurance of Administering Methylphenidate in Adults With ADHD
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) in last study-week (Placebo vs. Verum, double-blind phase, week 6)
Secondary outcome: CAARS-Self-Report: Long Version (CAARS-S:L)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Michael Rösler, Prof. Dr., Phone: +49 681 302
Zentralinstitut für seelische Gesundheit, Mannheim 68159, Germany; Recruiting
Alm
Sobanski
Barbara Alm, Dr., Principal Investigator
Universitätsklinik Bochum, Bochum 44791, Germany; Recruiting
Edel
Marc-Andreas Edel, Dr., Principal Investigator
Praxis Johannes Fuhr, Bad Wildungen 34537, Germany; Recruiting
Fuhr
Johannes Fuhr, Principal Investigator
Praxis Dr. Heinrich Goossens-Merkt, Hamburg 22527, Germany; Recruiting
Goossens-Merkt
Heinrich Goossens-Merkt, Dr., Sub-Investigator
Gemeinschaftspraxis für Kinder- und Jugendpsychiatrie, Psychotherapie, Berlin 10789, Germany; Recruiting
Greven
Peter Greven, Dr., Principal Investigator
Charité Campus Mitte, Station 155, Berlin 10117, Germany; Recruiting
Hein
Jakob Hein, Dr., Principal Investigator
Universitäts-Klinik Eppendorf,, Hamburg 20246, Germany; Recruiting
Mautner
Victor-Felix Mautner, Dr., Principal Investigator
Universität des Saarlandes, Institut für gerichtliche Psychiatrie, Homburg 66421, Germany; Recruiting
Rösler
Michael Rösler, Dr., Principal Investigator
Praxis Thomas Wirth, Ludwigsburg 71636, Germany; Recruiting
Wirth
Thomas Wirth, Principal Investigator
Universitätsklinikum Freiburg, Abteilung für Psychiatrie und Psychotherapie, Freiburg 79104, Germany; Recruiting
Philipsen
Alexandra Philipsen, Dr., Principal Investigator
Medizinisches Studienzentrum Würzburg, Würzburg 97070, Germany; Recruiting
Oehler
Klaus-Ulrich Oehler, Dr., Principal Investigator
Additional Information
Starting date: September 2008
Last updated: September 10, 2008
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