Adult Attention-deficit/Hyperactivity DisorderIDEANCT01615679
Integrated Diagnosis and Treatment of Adults With Attention-deficit/Hyperactivity Disorder
An observational study of Adult Attention-deficit/Hyperactivity Disorder, run by Medice Arzneimittel Pütter GmbH & Co KG at 1 site in Germany.
Trial summary
Non-interventional study to gain further information about the therapy progression in routine treatment of adults with attention-deficit/hyperactivity disorder (ADHD). Main focus will be on the improvement of the clinical global impression (CGI) in comparison to the outcome of randomized, controlled studies. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adult Attention-deficit/Hyperactivity Disorder
- How many people
- 468 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2012to Aug 2014
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with newly diagnosed ADHD who shall be treated with Medikinet(R) adult.
Who may be able to join
- Adult patients with newly diagnosed ADHD
Who cannot join
- Known sensitivity to methylphenidate or any of the excipients
- Glaucoma
- Phaeochromocytoma
- During treatment with non-selective, irreversible monoamine oxidase (MAO) inhibitors, or within a minimum of 14 days of discontinuing those drugs, due to risk of hypertensive crisis
- Hyperthyroidism or Thyrotoxicosis
- Diagnosis or history of severe depression, anorexia nervosa/anorexic disorders, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic/borderline personality disorder.
Show all 10Show fewer
- Diagnosis or history of severe and episodic (Type I) Bipolar (affective) Disorder (that is not well-controlled)
- pre-existing cardiovascular disorders including severe hypertension, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias and channelopathies (disorders caused by the dysfunction of ion channels)
- pre-existing cerebrovascular disorders cerebral aneurysm, vascular abnormalities including vasculitis or stroke
- a history of pronounced anacidity of the stomach with a pH value above 5.5, in therapy with H2-receptor blockers or in antacid therapy,
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universität des Saarlandes, Gerichtliche Psychologie und Psychiatrie
Homburg
About this study
Official title: Integrated Diagnosis and Treatment of Adults With Attention-deficit/Hyperactivity Disorder (ADHD)
Non-interventional study to gain further information about the therapy progression in routine treatment of adults with attention-deficit/hyperactivity disorder (ADHD). Main focus will be on the improvement of the clinical global impression (CGI) in comparison to the outcome of randomized, controlled studies.
- Keywords
- Non-interventional study, Attention Deficit/Hyperactivity Disorder, ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression (CGI)
Measured: 12-14 weeks
Secondary outcomes (1)
Wender-Reimherr adult attention deficit disorder scale (WRAADDS) - self-report
Measured: 12-14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startAug 2012
- Primary completionMar 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 468 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medice Arzneimittel Pütter GmbH & Co KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roland Fischer, Dr., Study chair, Medice Arzneimittel Pütter GmbH & Co KGMichael Rösler, Prof. Dr., Study director, Universität des Saarlandes, Institut für Gerichtliche Psychologie und Psychiatrie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615679
- Sponsor's protocol ID
- 6520-0660-02
- Acronym
- IDEA
- Status last verified
- Apr 2015
- First submitted
- 6 Jun 2012
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Diagnosis and Treatment of Adults With Attention-deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT01615679
- Acronym / sponsor ID
- IDEA / 6520-0660-02
- Keywords
- Non-interventional study, Attention Deficit/Hyperactivity Disorder, ADHD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 468 participants (actual)
- Lead sponsor
- Medice Arzneimittel Pütter GmbH & Co KGIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 8 Jun 2012 (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.
Non-interventional study to gain further information about the therapy progression in routine treatment of adults with attention-deficit/hyperactivity disorder (ADHD). Main focus will be on the improvement of the clinical global impression (CGI) in comparison to the outcome of randomized, controlled studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with newly diagnosed ADHD who shall be treated with Medikinet(R) adult.
Key inclusion criteria (1 listed)
- Adult patients with newly diagnosed ADHD
Key exclusion criteria (10 listed)
- Known sensitivity to methylphenidate or any of the excipients
- Glaucoma
- Phaeochromocytoma
- During treatment with non-selective, irreversible monoamine oxidase (MAO) inhibitors, or within a minimum of 14 days of discontinuing those drugs, due to risk of hypertensive crisis
- Hyperthyroidism or Thyrotoxicosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Global Impression (CGI)
Time frame: 12-14 weeks
1 secondary outcome
Wender-Reimherr adult attention deficit disorder scale (WRAADDS) - self-report
Time frame: 12-14 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 15 Apr 2015.
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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 Psychologie und Psychiatrie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult 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 1 inclusion and 10 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 15 Apr 2015. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Clinical Global Impression (CGI) (time frame: 12-14 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 15 Apr 2015.