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

Purpose

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

Condition	Intervention	Phase
Attention Deficit Hyperactivity Disorder	Drug: methylphenidate hydrochloride Drug: Placebo	Phase III

MedlinePlus related topics:

Attention Deficit Hyperactivity Disorder

Drug Information available for:

Methylphenidate hydrochloride Methylphenidate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	Quality Assurance of Administering Methylphenidate in Adults With ADHD

Further study details as provided by Medice Arzneimittel Pütter GmbH & Co KG:

Primary Outcome Measures:

Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) in last study-week (Placebo vs. Verum, double-blind phase, week 6) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CAARS-Self-Report: Long Version (CAARS-S:L) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	September 2008
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: methylphenidate hydrochloride sustained release, twice daily, dosage according to an individual titration schedule
2: Placebo Comparator	Drug: Placebo twice daily according to an individual titration schedule

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730249

Contacts


Contact: Michael Rösler, Prof. Dr.	+49 681 302 ext 0

Contact: Wolfgang Retz, Prof. Dr.

Locations


Germany
	Zentralinstitut für seelische Gesundheit	Recruiting
	Mannheim, Germany, 68159
	Contact: Alm
	Contact: Sobanski
	Principal Investigator: Barbara Alm, Dr.
	Universitätsklinik Bochum	Recruiting
	Bochum, Germany, 44791
	Contact: Edel
	Principal Investigator: Marc-Andreas Edel, Dr.
	Praxis Johannes Fuhr	Recruiting
	Bad Wildungen, Germany, 34537
	Contact: Fuhr
	Principal Investigator: Johannes Fuhr
	Praxis Dr. Heinrich Goossens-Merkt	Recruiting
	Hamburg, Germany, 22527
	Contact: Goossens-Merkt
	Sub-Investigator: Heinrich Goossens-Merkt, Dr.
	Gemeinschaftspraxis für Kinder- und Jugendpsychiatrie, Psychotherapie	Recruiting
	Berlin, Germany, 10789
	Contact: Greven
	Principal Investigator: Peter Greven, Dr.
	Medizinisches Studienzentrum Würzburg	Recruiting
	Würzburg, Germany, 97070
	Contact: Oehler
	Principal Investigator: Klaus-Ulrich Oehler, Dr.
	Universitäts-Klinik Eppendorf,	Recruiting
	Hamburg, Germany, 20246
	Contact: Mautner
	Principal Investigator: Victor-Felix Mautner, Dr.
	Universität des Saarlandes, Institut für gerichtliche Psychiatrie	Recruiting
	Homburg, Germany, 66421
	Contact: Rösler
	Principal Investigator: Michael Rösler, Dr.
	Praxis Thomas Wirth	Recruiting
	Ludwigsburg, Germany, 71636
	Contact: Wirth
	Principal Investigator: Thomas Wirth
	Universitätsklinikum Freiburg, Abteilung für Psychiatrie und Psychotherapie	Recruiting
	Freiburg, Germany, 79104
	Contact: Philipsen
	Principal Investigator: Alexandra Philipsen, Dr.
	Charité Campus Mitte, Station 155	Recruiting
	Berlin, Germany, 10117
	Contact: Hein
	Principal Investigator: Jakob Hein, Dr.

Sponsors and Collaborators

Medice Arzneimittel Pütter GmbH & Co KG

Investigators


Study Chair:	Roland Fischer, Dr.	Medice Arzneimittel Pütter GmbH & Co KG

Study Director:	Michael Rösler, Prof. Dr.	Universität des Saarlandes, Institut für gerichtliche Psychiatrie

More Information

Responsible Party:	Medice Arzneimittel Pütter GmbH & Co. KG ( Dr. Roland Fischer/Head of Medical Dept. )
Study ID Numbers:	6520-0650-13
First Received:	August 6, 2008
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00730249
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Medice Arzneimittel Pütter GmbH & Co KG:

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

Study placed in the following topic categories:

Signs and Symptoms

Dopamine

Attention Deficit Disorder with Hyperactivity

Mental Disorders

Mental Disorders Diagnosed in Childhood

Methylphenidate

Neurologic Manifestations

Attention Deficit and Disruptive Behavior Disorders

Hyperkinesis

Dyskinesias

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors

Neurotransmitter Agents

Neurotransmitter Uptake Inhibitors

Disease

Molecular Mechanisms of Pharmacological Action

Nervous System Diseases

Physiological Effects of Drugs

Central Nervous System Stimulants

Pharmacologic Actions

Pathologic Processes

Therapeutic Uses

Dopamine Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	Medice Arzneimittel Pütter GmbH & Co KG
Information provided by:	Medice Arzneimittel Pütter GmbH & Co KG
ClinicalTrials.gov Identifier:	NCT00730249