Attention Deficit Hyperactivity DisorderPhase 3QUMEANCT00730249
Quality Assurance of Administering Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD) - QUMEA
A Phase 3 study testing methylphenidate hydrochloride in people with Attention Deficit Hyperactivity Disorder, run by Medice Arzneimittel Pütter GmbH & Co KG at 11 sites in Germany.
Trial summary
Investigation of efficacy of high-dose extended-release Methylphenidate in adults with ADHD, compared with a placebo Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- methylphenidate hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 11 sitesGermany
- Study dates
- Sep 2008to Jan 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 35Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Germany11 sites
Praxis Johannes Fuhr
Bad Wildungen, 34537
Charité Campus Mitte, Station 155
Berlin, 10117
Gemeinschaftspraxis für Kinder- und Jugendpsychiatrie, Psychotherapie
Berlin, 10789
Universitätsklinik Bochum
Bochum, 44791
Universitätsklinikum Freiburg, Abteilung für Psychiatrie und Psychotherapie
Freiburg im Breisgau, 79104
Universitäts-Klinik Eppendorf,
Hamburg, 20246
Praxis Dr. Heinrich Goossens-Merkt
Hamburg, 22527
Universität des Saarlandes, Institut für gerichtliche Psychiatrie
Homburg, 66421
Praxis Thomas Wirth
Ludwigsburg, 71636
Zentralinstitut für seelische Gesundheit
Mannheim, 68159
Medizinisches Studienzentrum Würzburg
Würzburg, 97070
About this study
Official title: 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
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- methylphenidate hydrochloride, Placebo
- Keywords
- 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
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylphenidate hydrochlorideDrug
Also called Medikinet retard
sustained release, twice daily, dosage according to an individual titration schedule
PlaceboDrug
twice daily according to an individual titration schedule
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: methylphenidate hydrochloride |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) in last study-week (Placebo vs. Verum, double-blind phase, week 6)
Measured: 20 weeks
Secondary outcomes (1)
CAARS-Self-Report: Long Version (CAARS-S:L)
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medice Arzneimittel Pütter GmbH & Co KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Roland Fischer, Dr., Study chair, Medice Arzneimittel Pütter GmbH & Co KGMichael Rösler, Prof. Dr., Study director, Universität des Saarlandes, Institut für gerichtliche Psychiatrie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730249
- Sponsor's protocol ID
- 6520-0650-13
- Acronym
- QUMEA
- Status last verified
- Jan 2010
- First submitted
- 6 Aug 2008
- Last updated
- 13 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Assurance of Administering Methylphenidate in Adults With ADHD
- ClinicalTrials.gov ID
- NCT00730249
- Acronym / sponsor ID
- QUMEA / 6520-0650-13
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Attention Deficit Hyperactivity Disorder, adult, methylphenidate hydrochloride, Medikinet retard, controlled clinical trial, safety, randomized, double-blind, placebo-controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Medice Arzneimittel Pütter GmbH & Co KGIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Jan 2010 (actual)
- First posted
- 8 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigation of efficacy of high-dose extended-release Methylphenidate in adults with ADHD, compared with a placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: methylphenidate hydrochloride |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (35 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylphenidate hydrochlorideAlso: Medikinet retardsustained release, twice daily, dosage according to an individual titration schedule | Drug | 1 |
| Placebotwice daily according to an individual titration schedule | Drug | 2 |
Primary outcome
Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) in last study-week (Placebo vs. Verum, double-blind phase, week 6)
Time frame: 20 weeks
1 secondary outcome
CAARS-Self-Report: Long Version (CAARS-S:L)
Time frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland Fischer, Dr. study chair
Medice Arzneimittel Pütter GmbH & Co KG
Michael Rösler, Prof. Dr. study director
Universität des Saarlandes, Institut für gerichtliche Psychiatrie
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing methylphenidate hydrochloride in people with Attention Deficit Hyperactivity Disorder, run by Medice Arzneimittel Pütter GmbH & Co KG at 11 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) in last study-week (Placebo vs. Verum, double-blind phase, week 6) (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2010.