ADHDPhase 4ASTANCT00852059
Adherence to Stimulant Treatment in Attention-Deficit Hyperactivity Disorder (ADHD) Patients (ASTA)
A Phase 4 study testing Immediate release methylphenidate (Medikinet®) and Extended release methylphenidate (Medikinet retard®) in people with ADHD, run by Prof. Huss at 1 site in Germany.
Trial summary
This study determined to measure non-adherence assessed by the number of non-adherent days during the clinical trial of 100 days using the Medication Event Monitoring System (MEMS). Study Design: prospective multi-centric open-label randomized active-controlled trial Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- ADHD
- What is being tested?
- Immediate release methylphenidate (Medikinet®) and Extended release methylphenidate (Medikinet retard®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2009to Dec 2013
- Phase
- Phase 4
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Written informed consent (separately for children aged 6-11 years and 12-17 years)
- Children and adolescents of both sexes aged 6 - 17 years
- Confirmed diagnosis of ADHD by semi structured-clinical interview K-SADS
- ADHDRS-IV-Parent Version (18-Item-Scale) raw score ≥ 1,5 SD above norm under non-medicated conditions (either drug holiday or prior to medication within the past 6 months)
- Effective treatment with a stable dose of methylphenidate for at least one month (max. 60 mg/day) proved by a 25% symptom reduction in ADHD-RS under medication, compared to retrospective ADHD-RS without medication within the past 6 months.
- Acceptance and capability to swallow capsules of product size, proved by an equally sized placebo provided by Medice®.
- Sufficient knowledge of the German language
- Adequate contraception in case of sexual activity
Who cannot join
- Contraindications against methylphenidate
- Previous stable methylphenidate intake more than twice daily
- All severe psychiatric disorders except oppositional defiant disorder (ODD) or conduct disorder. In order to reflect the usual co-morbid spectrum of ADHD, mild or moderate anxiety or depressive disorders are accepted in the study.
- All severe somatic diseases as assessed by the baseline examination or medical history (including life-time history of epileptic disorders)
- Pathological results for vital signs, blood pressure and pulse
- Reported pathological results for ECG during the last 12 months
Show all 14Show fewer
- Reported pathological results for differential blood count and hepatic metabolism during the last 6 months
- Indication for hospitalization
- Suicidality (assessed by MADRS Item 10, Score ≥ 3)
- IQ < 70 (clinically assessed)
- Any psychotropic co-medication
- Detention in an institution on official or judicial ruling
- Unwillingness to transmit pseudonym data according to German regulations
- Simultaneous participation in another clinical trial according to German Drug Law (AMG)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Körperschaft des öffentlichen Rechts
Mainz, 55131
About this study
Official title: Effect of Methylphenidate Formulation on ADHD-patients' Adherence to Medical Treatment. A Comparison of Medikinet Retard® (ER) Once Daily and Medikinet® (IR) Twice Daily in Children and Adolescents Diagnosed With ADHD
This study determined to measure non-adherence assessed by the number of non-adherent days during the clinical trial of 100 days using the Medication Event Monitoring System (MEMS).
Study Design:
- prospective
- multi-centric
- open-label
- randomized
- active-controlled trial
Read the detailed description
The study is designed as a prospective, multi-centric, open-label, randomized, active-controlled trial. ADHD-children and adolescents of both sexes, 6-17 of age, effectively treated with stimulants are recruited in two centres. Over a naturalistic run-in phase of four weeks adherence to medication taken before randomisation is measured. In the subsequent controlled clinical trial 50% of the participants are randomized to extended release (ER) methylphenidate (Medikinet retard®) applied with breakfast, 50% are randomized to immediate release (IR) methylphenidate (Medikinet®) in the morning and 3-4 h later (clinical trial). To optimize ecological validity, no double-dummy technique is applied; the allocation to either study arm is non-blinded.
According to the power calculation 106 patients will be randomized. The total duration of the study is 18 months. Starting with a run-in visit, each eligible patient is observed in the naturalistic run-in phase for four weeks. Subsequently, patients participate 100 days in the clinical trial starting with a baseline visit, an in between-visit and a final visit. Medical care is provided in the routine program of both study centres. To record the adherence, medication events are counted by Medication Event Monitoring System (MEMS).
- Conditions
- ADHD
- Being tested
- Immediate release methylphenidate (Medikinet®), Extended release methylphenidate (Medikinet retard®)
- Keywords
- ADHD, children, adolescents, methylphenidate, adherence, immediate release, extended release, efficacy
- 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.
Immediate release methylphenidate (Medikinet®)Drug
Also called Medikinet®
Treatment: methylphenidate in the morning and 3-4 h later (twice daily), immediate release
Extended release methylphenidate (Medikinet retard®)Drug
Also called Medikinet retard®
Treatment: methylphenidate applied with breakfast(once daily), extended release
| Study group | Role | What they receive |
|---|---|---|
| Immediate release | Experimental | Treatment with immediate release (IR) methylphenidate (Medikinet®) in the morning and 3-4 h later (twice a day) Receives: Drug: Immediate release methylphenidate (Medikinet®) |
| Extended release | Active comparator | Treatment with extended release (ER) methylphenidate (Medikinet reatard®) applied with breakfast(once daily) Receives: Drug: Extended release methylphenidate (Medikinet retard®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-adherence assessed by the number of non-adherent days during the clinical trial of 100 days using the Medication Event Monitoring System (MEMS)
Measured: 100 days
Secondary outcomes (4)
Number of non-adherent days measured by pill count
Measured: 100 days
Time interval until a total number of 30 days of non-adherence is reached cumulatively during the clinical trial measured by MEMS
Measured: 100 days
Quality of life during measured by Child Health Illness Profile - Child Edition (CHIP-CE) Score
Measured: 100 days
The efficacy of stimulant treatment during the clinical trial measured by ADHD-Rating Scale- Parent Version Sum Score
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Diffculties to recruit anticipated study size, now analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Huss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Huss, Johannes Gutenberg University Mainz
- Investigators
- Michael Huss, Prof. Dr., Principal investigator, Johannes Gutenberg University, Mainz, Dep. of Child and Adolescent Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852059
- Sponsor's protocol ID
- JoGu_KJP_ASTA-3285-26
- Acronym
- ASTA
- Status last verified
- May 2014
- First submitted
- 25 Feb 2009
- Last updated
- 7 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Methylphenidate Formulation on ADHD-patients' Adherence to Medical Treatment. A Comparison of Medikinet Retard® (ER) Once Daily and Medikinet® (IR) Twice Daily in Children and Adolescents Diagnosed With ADHD
- ClinicalTrials.gov ID
- NCT00852059
- Acronym / sponsor ID
- ASTA / JoGu_KJP_ASTA-3285-26
- Conditions
- ADHD
- Keywords
- ADHD, children, adolescents, methylphenidate, adherence, immediate release, extended release, efficacy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Diffculties to recruit anticipated study size, now analysis
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Prof. HussUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Feb 2009 (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.
This study determined to measure non-adherence assessed by the number of non-adherent days during the clinical trial of 100 days using the Medication Event Monitoring System (MEMS).
Study Design:
- prospective
- multi-centric
- open-label
- randomized
- active-controlled trial
Detailed description
The study is designed as a prospective, multi-centric, open-label, randomized, active-controlled trial. ADHD-children and adolescents of both sexes, 6-17 of age, effectively treated with stimulants are recruited in two centres. Over a naturalistic run-in phase of four weeks adherence to medication taken before randomisation is measured. In the subsequent controlled clinical trial 50% of the participants are randomized to extended release (ER) methylphenidate (Medikinet retard®) applied with breakfast, 50% are randomized to immediate release (IR) methylphenidate (Medikinet®) in the morning and 3-4 h later (clinical trial). To optimize ecological validity, no double-dummy technique is applied; the allocation to either study arm is non-blinded.
According to the power calculation 106 patients will be randomized. The total duration of the study is 18 months. Starting with a run-in visit, each eligible patient is observed in the naturalistic run-in phase for four weeks. Subsequently, patients participate 100 days in the clinical trial starting with a baseline visit, an in between-visit and a final visit. Medical care is provided in the routine program of both study centres. To record the adherence, medication events are counted by Medication Event Monitoring System (MEMS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate release | Experimental | Drug: Immediate release methylphenidate (Medikinet®)Treatment with immediate release (IR) methylphenidate (Medikinet®) in the morning and 3-4 h later (twice a day) |
| Extended release | Active comparator | Drug: Extended release methylphenidate (Medikinet retard®)Treatment with extended release (ER) methylphenidate (Medikinet reatard®) applied with breakfast(once daily) |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Written informed consent (separately for children aged 6-11 years and 12-17 years)
- Children and adolescents of both sexes aged 6 - 17 years
- Confirmed diagnosis of ADHD by semi structured-clinical interview K-SADS
- ADHDRS-IV-Parent Version (18-Item-Scale) raw score ≥ 1,5 SD above norm under non-medicated conditions (either drug holiday or prior to medication within the past 6 months)
- Effective treatment with a stable dose of methylphenidate for at least one month (max. 60 mg/day) proved by a 25% symptom reduction in ADHD-RS under medication, compared to retrospective ADHD-RS without medication within the past 6 months.
Key exclusion criteria (14 listed)
- Contraindications against methylphenidate
- Previous stable methylphenidate intake more than twice daily
- All severe psychiatric disorders except oppositional defiant disorder (ODD) or conduct disorder. In order to reflect the usual co-morbid spectrum of ADHD, mild or moderate anxiety or depressive disorders are accepted in the study.
- All severe somatic diseases as assessed by the baseline examination or medical history (including life-time history of epileptic disorders)
- Pathological results for vital signs, blood pressure and pulse
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 |
|---|---|---|
| Immediate release methylphenidate (Medikinet®)Also: Medikinet®Treatment: methylphenidate in the morning and 3-4 h later (twice daily), immediate release | Drug | Immediate release |
| Extended release methylphenidate (Medikinet retard®)Also: Medikinet retard®Treatment: methylphenidate applied with breakfast(once daily), extended release | Drug | Extended release |
Primary outcome
Non-adherence assessed by the number of non-adherent days during the clinical trial of 100 days using the Medication Event Monitoring System (MEMS)
Time frame: 100 days
4 secondary outcomes
Number of non-adherent days measured by pill count
Time frame: 100 days
Time interval until a total number of 30 days of non-adherence is reached cumulatively during the clinical trial measured by MEMS
Time frame: 100 days
Quality of life during measured by Child Health Illness Profile - Child Edition (CHIP-CE) Score
Time frame: 100 days
The efficacy of stimulant treatment during the clinical trial measured by ADHD-Rating Scale- Parent Version Sum Score
Time frame: 100 days
Results and safety
The study was stopped early (reason given: Diffculties to recruit anticipated study size, now analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2014.
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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 Huss, Prof. Dr. principal investigator
Johannes Gutenberg University, Mainz, Dep. of Child and Adolescent Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Immediate release methylphenidate (Medikinet®) and Extended release methylphenidate (Medikinet retard®) in people with ADHD, run by Prof. Huss 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 8 inclusion and 14 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: stopped early, as of the sponsor's last update on 7 May 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Diffculties to recruit anticipated study size, now analysis). Results are not available in the source record.
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?
Non-adherence assessed by the number of non-adherent days during the clinical trial of 100 days using the Medication Event Monitoring System (MEMS) (time frame: 100 days). 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 7 May 2014.