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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00730249
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : January 13, 2010
Information provided by:
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

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: methylphenidate hydrochloride Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Quality Assurance of Administering Methylphenidate in Adults With ADHD
Study Start Date : September 2008
Actual Primary Completion Date : January 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1 Drug: methylphenidate hydrochloride
sustained release, twice daily, dosage according to an individual titration schedule
Other Name: Medikinet retard

Placebo Comparator: 2 Drug: Placebo
twice daily according to an individual titration schedule

Primary Outcome Measures :
  1. Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) in last study-week (Placebo vs. Verum, double-blind phase, week 6) [ Time Frame: 20 weeks ]

Secondary Outcome Measures :
  1. CAARS-Self-Report: Long Version (CAARS-S:L) [ Time Frame: 20 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00730249

Praxis Johannes Fuhr
Bad Wildungen, Germany, 34537
Charité Campus Mitte, Station 155
Berlin, Germany, 10117
Gemeinschaftspraxis für Kinder- und Jugendpsychiatrie, Psychotherapie
Berlin, Germany, 10789
Universitätsklinik Bochum
Bochum, Germany, 44791
Universitätsklinikum Freiburg, Abteilung für Psychiatrie und Psychotherapie
Freiburg, Germany, 79104
Universitäts-Klinik Eppendorf,
Hamburg, Germany, 20246
Praxis Dr. Heinrich Goossens-Merkt
Hamburg, Germany, 22527
Universität des Saarlandes, Institut für gerichtliche Psychiatrie
Homburg, Germany, 66421
Praxis Thomas Wirth
Ludwigsburg, Germany, 71636
Zentralinstitut für seelische Gesundheit
Mannheim, Germany, 68159
Medizinisches Studienzentrum Würzburg
Würzburg, Germany, 97070
Sponsors and Collaborators
Medice Arzneimittel Pütter GmbH & Co KG
Study Chair: Roland Fischer, Dr. Medice Arzneimittel Pütter GmbH & Co KG
Study Director: Michael Rösler, Prof. Dr. Universität des Saarlandes, Institut für gerichtliche Psychiatrie

Responsible Party: Dr. Roland Fischer/Head of Medical Dept., Medice Arzneimittel Pütter GmbH & Co. KG Identifier: NCT00730249     History of Changes
Other Study ID Numbers: 6520-0650-13
First Posted: August 8, 2008    Key Record Dates
Last Update Posted: January 13, 2010
Last Verified: January 2010

Keywords provided by Medice Arzneimittel Pütter GmbH & Co KG:
Attention Deficit Hyperactivity Disorder
methylphenidate hydrochloride
Medikinet retard
controlled clinical trial
randomized, double-blind, placebo-controlled trial
central nervous system stimulants
therapeutic uses

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents