Attention Deficit Hyperactivity DisorderPhase 3EMMANCT00619840
Placebo-Controlled Multi-Centre Double-Blind Trial for Adults With Extended-Release Methylphenidate for ADHD
A Phase 3 study testing methylphenidate hydrochloride in people with Attention Deficit Hyperactivity Disorder, run by Medice Arzneimittel Pütter GmbH & Co KG at 1 site in Germany.
Trial summary
Investigation of efficacy and tolerability of extended-release MPD in adults with ADHD, compared with a placebo, and to acquire knowledge through long-term observation of adults 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 363 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2004to May 2006
- 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 outpatient or inpatient
- Patient has a good command of German
- Score of 85 or greater in the IQ test (MWT-B)
- Diagnosis of ADHD according to ADHD-CL (DSM IV) and WRI-WRAADDS > 28 points
- ADHD symptoms have existed since childhood (WURS-k >= 30)
- Body mass index >= 20
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- Willing to eat breakfast
- 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 2 weeks
- Inconsistencies in the CAARS- S:L >= 8 (Inconsistency Index)
- Shift work or night work
- Alcohol, medication or drug dependency in the past 6 months or manifest drug abuse
- Diagnosis of a psychosis (SKID-I)
- Epileptic attacks in the past
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- EEG results which suggest epilepsy
- Clinically relevant liver disease
- Clinically relevant hyperthyroidism (relevantly elevated TSH, T4)
- Acute depressive episode according to ICD-10 F32.2 and ICD-10 32.3 (SKID-I)
- Illnesses 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
- Known high blood pressure
- Known occlusive arterial disease
- Known angina pectoris
- Known coronary heart disease and state after myocardial infarction
- Known tachycardial arrhythmias
- Post-stroke status
- Known elevated intra-occular pressure
- Known enlarged prostates
- 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
- Patients with terminal illness (e.g. cancer)
- Pregnancy (positive pregnancy test) or lactation period
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Forensic Psychology and Psychiatry
Homburg/Saar, Saarland, 66421
About this study
Investigation of efficacy and tolerability of extended-release MPD in adults with ADHD, compared with a placebo, and to acquire knowledge through long-term observation of adults
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- methylphenidate hydrochloride, Placebo
- Keywords
- ADHD, Attention Deficit Hyperactivity Disorder, adult, methylphenidate hydrochloride, Medikinet retard, long-term observation, 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, 10 mg capsule 1-3 capsules twice daily according to an individual titration schedule
PlaceboDrug
10 mg capsule 1-3 capsules 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.
German validated version of the WRAADDS: Wender-Reimherr-Interview (WRI)
Measured: Week 24
Secondary outcomes (1)
CAARS self report: long version (CAARS-S:L)
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startNov 2004
- Primary completionMay 2006
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
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medice Arzneimittel Pütter GmbH & Co KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Rösler, Prof. Dr., Principal investigator, Institute of Forensic Psychology and Psychiatry, University of Saarland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619840
- Sponsor's protocol ID
- 6520-9979-06
- Acronym
- EMMA
- Status last verified
- Feb 2008
- First submitted
- 11 Feb 2008
- Last updated
- 21 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled Multi-Centre Double-Blind Trial for Adults With Extended-Release Methylphenidate for ADHD
- ClinicalTrials.gov ID
- NCT00619840
- Acronym / sponsor ID
- EMMA / 6520-9979-06
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Attention Deficit Hyperactivity Disorder, adult, methylphenidate hydrochloride, Medikinet retard, long-term observation, controlled clinical trial, safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Medice Arzneimittel Pütter GmbH & Co KGIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- May 2006 (actual)
- First posted
- 21 Feb 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 and tolerability of extended-release MPD in adults with ADHD, compared with a placebo, and to acquire knowledge through long-term observation of adults
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 (9 listed)
- Patient treated as outpatient or inpatient
- Patient has a good command of German
- Score of 85 or greater in the IQ test (MWT-B)
- Diagnosis of ADHD according to ADHD-CL (DSM IV) and WRI-WRAADDS > 28 points
- ADHD symptoms have existed since childhood (WURS-k >= 30)
Key exclusion criteria (30 listed)
- Treatment with psychostimulants in the past 2 weeks
- Inconsistencies in the CAARS- S:L >= 8 (Inconsistency Index)
- Shift work or night work
- Alcohol, medication or drug dependency in the past 6 months or manifest drug abuse
- Diagnosis of a psychosis (SKID-I)
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, 10 mg capsule 1-3 capsules twice daily according to an individual titration schedule | Drug | 1 |
| Placebo10 mg capsule 1-3 capsules twice daily according to an individual titration schedule | Drug | 2 |
Primary outcome
German validated version of the WRAADDS: Wender-Reimherr-Interview (WRI)
Time frame: Week 24
1 secondary outcome
CAARS self report: long version (CAARS-S:L)
Time frame: Week 24
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 21 Feb 2008.
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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.
Michael Rösler, Prof. Dr. principal investigator
Institute of Forensic Psychology and Psychiatry, University of Saarland
1 site 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 1 site 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 9 inclusion and 30 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 21 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
German validated version of the WRAADDS: Wender-Reimherr-Interview (WRI) (time frame: Week 24). 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 21 Feb 2008.