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

This study has been completed.
Sponsor:
Information provided by:
Medice Arzneimittel Pütter GmbH & Co KG
ClinicalTrials.gov Identifier:
NCT00730249
First received: August 6, 2008
Last updated: January 12, 2010
Last verified: January 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Quality Assurance of Administering Methylphenidate in Adults With ADHD

Resource links provided by NLM:


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
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Praxis Johannes Fuhr
Bad Wildungen, Germany, 34537
Gemeinschaftspraxis für Kinder- und Jugendpsychiatrie, Psychotherapie
Berlin, Germany, 10789
Charité Campus Mitte, Station 155
Berlin, Germany, 10117
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
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

No publications provided

Responsible Party: Dr. Roland Fischer/Head of Medical Dept., Medice Arzneimittel Pütter GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00730249     History of Changes
Other Study ID Numbers: 6520-0650-13
Study First Received: August 6, 2008
Last Updated: January 12, 2010
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

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Disease
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pathologic Processes
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014