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

January 12, 2010 updated by: Medice Arzneimittel Pütter GmbH & Co KG

Quality Assurance of Administering Methylphenidate in Adults With ADHD

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Wildungen, Germany, 34537
        • Praxis Johannes Fuhr
      • Berlin, Germany, 10117
        • Charité Campus Mitte, Station 155
      • Berlin, Germany, 10789
        • Gemeinschaftspraxis für Kinder- und Jugendpsychiatrie, Psychotherapie
      • Bochum, Germany, 44791
        • Universitätsklinik Bochum
      • Freiburg, Germany, 79104
        • Universitätsklinikum Freiburg, Abteilung für Psychiatrie und Psychotherapie
      • Hamburg, Germany, 20246
        • Universitäts-Klinik Eppendorf,
      • Hamburg, Germany, 22527
        • Praxis Dr. Heinrich Goossens-Merkt
      • Homburg, Germany, 66421
        • Universität des Saarlandes, Institut für gerichtliche Psychiatrie
      • Ludwigsburg, Germany, 71636
        • Praxis Thomas Wirth
      • Mannheim, Germany, 68159
        • Zentralinstitut für seelische Gesundheit
      • Würzburg, Germany, 97070
        • Medizinisches Studienzentrum Würzburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Drug: Placebo
twice daily according to an individual titration schedule
Active Comparator: 1
Drug: methylphenidate hydrochloride
sustained release, twice daily, dosage according to an individual titration schedule
Other Names:
  • Medikinet retard

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
CAARS-Self-Report: Long Version (CAARS-S:L)
Time Frame: 20 weeks
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

August 6, 2008

First Submitted That Met QC Criteria

August 7, 2008

First Posted (Estimate)

August 8, 2008

Study Record Updates

Last Update Posted (Estimate)

January 13, 2010

Last Update Submitted That Met QC Criteria

January 12, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6520-0650-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Attention Deficit Hyperactivity Disorder

Clinical Trials on methylphenidate hydrochloride

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe