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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medice Arzneimittel Pütter GmbH & Co KG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 6, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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