Clinical trial NCT00730249: Quality Assurance of Administering Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD) - QUMEA
Official title: Quality Assurance of Administering Methylphenidate in Adults With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Attention Deficit Hyperactivity Disorder
adult
methylphenidate hydrochloride
Medikinet retard
controlled clinical trial
safety
randomized, double-blind, placebo-controlled trial
treatment
central nervous system stimulants
therapeutic uses
Lead sponsor: Medice Arzneimittel Pütter GmbH & Co KG
Sponsor class: INDUSTRY
First posted: 2008-08-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) in last study-week (Placebo vs. Verum, double-blind phase, week 6)
timeFrame: 20 weeks
Secondary outcomes:
measure: CAARS-Self-Report: Long Version (CAARS-S:L)
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Bad Wildungen
country: Germany
facility: Praxis Johannes Fuhr
city: Berlin
country: Germany
facility: Charité Campus Mitte, Station 155
city: Berlin
country: Germany
facility: Gemeinschaftspraxis für Kinder- und Jugendpsychiatrie, Psychotherapie
city: Bochum
country: Germany
facility: Universitätsklinik Bochum
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg, Abteilung für Psychiatrie und Psychotherapie
city: Hamburg
country: Germany
facility: Universitäts-Klinik Eppendorf,
city: Hamburg
country: Germany
facility: Praxis Dr. Heinrich Goossens-Merkt
city: Homburg
country: Germany
facility: Universität des Saarlandes, Institut für gerichtliche Psychiatrie
city: Ludwigsburg
country: Germany
facility: Praxis Thomas Wirth
city: Mannheim
country: Germany
facility: Zentralinstitut für seelische Gesundheit
city: Würzburg
country: Germany
facility: Medizinisches Studienzentrum Würzburg
Study officials:
affiliation: Medice Arzneimittel Pütter GmbH & Co KG
name: Roland Fischer, Dr.
role: STUDY_CHAIR
affiliation: Universität des Saarlandes, Institut für gerichtliche Psychiatrie
name: Michael Rösler, Prof. Dr.
role: STUDY_DIRECTOR
References: