Attention Deficit Hyperactivity DisorderPhase 3NCT00506285
Methylphenidate Transdermal System (MTS) in the Treatment of Adult ADHD
A Phase 3 study testing Methylphenidate Transdermal System (MTS) in people with Attention Deficit Hyperactivity Disorder, run by University of Utah at 1 site in United States.
Trial summary
This study will look at the effectiveness of Methylphenidate Transdermal System (MTS) in treating adult ADHD. MTS has received FDA approval for childhood ADHD but this is the first trial for adult ADHD. Subjects will experience two screening visits and one baseline visit. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Methylphenidate Transdermal System (MTS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Apr 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Adults meeting DSM-IV-Text Revision criteria for ADHD, the Utah Criteria for ADHD, and experiencing at least moderate impairment (a score of 4 or greater on the CGI-Severity Scale for ADHD at both Screening and Baseline visits) will be enrolled. Other criteria include:
- Subjects ages 18 to 65, inclusive;
- Female subjects are eligible to enter and participate in this study only if:
- She is of non-childbearing potential; has a male sexual partner who is surgically sterilized; is on implant of levonorgestrel, injectable progesterone, or an oral contraceptive; has an intrauterine device (IUD); or is sexually inactive with a male partner.
- Or agrees to use a double barrier method of contraception (any combination of physical and chemical methods) and has a negative urine pregnancy test at screening interview.
- Subject must be in general good health as determined by medical history, ECG, and other analysis that, in the judgment of the study physician, would confirm the patient's good health.
- Subjects must read and write at a level sufficient to provide written informed consent and complete study-related materials.
Who cannot join
- Subjects will not be eligible for inclusion in this study if any of the following criteria apply:
- Subjects with other current DSM-IV Axis I Disorders including Current or lifetime history of psychosis, current bipolar disorder type I, current Major Depressive Disorder, and Current Anxiety Disorder (unless in the opinion of clinic physician ADHD is the primary disorder and causes the disability seen in the patient);
- Subjects with any other DSM-IV Axis II diagnosis so severe that it would suggest non-responsiveness to pharmacotherapy for ADHD or noncompliance with the protocol;
- Subjects at risk for suicide or a risk to harm others;
- History of Substance Dependence according to DSM-IV criteria within 3 months of screening;
- Subjects currently abusing illegal drugs or alcohol are excluded from the study;
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- Positive urine screen for drugs of abuse at screening for patients who have a significant history of substance use but still meet criteria 4 and 5. Patients not at risk for substance abuse will not be given a urine drug screen;
- Subjects in whom stimulants would represent a risk such as those with a history of stimulant abuse,
- History of uncontrolled hypertension or significant cardiovascular disease;
- Any known or suspected significant medical or psychiatric illnesses (e.g., hepatic or renal insufficiency, pulmonary (asthma, COPD, etc), gastrointestinal, endocrine, neurological or metabolic disturbances that, in the judgment of the investigator, may impair interpretation of study results or constitute a significant safety concern in the context of the clinical trial;
- Medications, including health food supplements judged by the investigator to be likely to have central nervous system activity (for example, St John's Wort, gingko leaf, and melatonin), are not permitted during the study. If the subject is taking the medication prior to study entry, there must be a 7 day washout period prior to Visit 2. We will ask for an honest report of all medications consumed between visits. In the event a medication with psychoactive properties is consumed, the patient will be counseled regarding the use of prohibited medications;
- Use of any medication not considered acceptable by the clinical investigator or the medical monitor during the 7-day period before the start of the study (Day 1);
- Subjects with high BMI (>38) and those with high adipose tissue concentrations in the hip as judged by the clinician.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah School of Medicine, Department of Psychiatry, Mood Disorders Clinic
Salt Lake City, Utah, 84132
About this study
This study will look at the effectiveness of Methylphenidate Transdermal System (MTS) in treating adult ADHD. MTS has received FDA approval for childhood ADHD but this is the first trial for adult ADHD. Subjects will experience two screening visits and one baseline visit. Those who meet admission criteria will enter the double-blind phase. This will involve two 4-week treatment periods one of which will involve the use of MTS and the other a placebo patch. Subjects who complete the double-blind phase will be allowed to enter a 180-day, open-label MTS phase designed to assess long-term effects.
Read the detailed description
ADHD affects from 3 to 5% of children, persists into adolescence in 40 to 70% of these children and continues into adulthood in at least 50% of affected adolescents. Methylphenidate was the first medication shown to be effective in treatment for adults with ADHD and continues to be widely used. While the extended release formulations represent an improvement over the immediate release versions, significant problems remain for many patients. In particular, most have been designed with the goal of providing medication only during school hours and a short time period after school. In adults, there is a frequent need for much more extended duration of treatment. MTS is a new form of methylphenidate that provides medication in a transdermal patch delivery system. It has a very even, slowly ascending pharmacokinetic profile. MTS's very stable slowly increasing blood level should overcome the problems noted above with a delivery system that is more convenient for many patients. It is currently approved for treatment of childhood ADHD, with effectiveness and safety profiles similar to other forms of methylphenidate. This study will be the first to evaluate the effectiveness and safety of MTS in adult ADHD.
This is a double-blind, placebo-controlled, randomized, crossover trial comparing MTS with placebo patch. The double-blind trial will be preceded by an enrollment period consisting of two screening visits followed as quickly as possible by a baseline visit. Patients who continue to meet admission criteria at baseline will be randomized into the first of two 4-week treatment periods. We will attempt to reach the highest tolerated dose size of MTS within 2 weeks and then observe the response over the last two weeks of each crossover phase. The double-blind period will be followed by a 180 day open-treatment, flexible-dose phase designed to assess long-term effects.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Methylphenidate Transdermal System (MTS), placebo patch
- Keywords
- Attention Deficit Hyperactivity Disorder, ADHD, Adult, Methylphenidate Transdermal System, Daytrana
- 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 Transdermal System (MTS)Drug
Also called Daytrana
MTS is an advanced patch product that provides methylphenidate evenly mixed with the adhesive. This formulation allows good adhesion and a wide range of dose sizes. MTS patch sizes of 12.5, 18.75, 25 and 37.5cm2 are equivalent to nominal doses over a 9-hour wear time of 10, 15, 20 and 30mg of MPH.
placebo patchOther
This patch is designed to appear identical to the actual intervention patch
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | This arm was 4 weeks long. Subjects were treated using Methylphenidate Transdermal System. Patients were seen weekly, phone contact was made between visits and dosing could be adjusted as a result of the phone contact. MTS was initiated using a 12.5 cm patch. The dose was increased during the first 2 weeks based on treatment response and side effects to the largest tolerated dose/patch size. It was held steady the last 2 weeks. Receives: Drug: Methylphenidate Transdermal System (MTS) |
| B | Placebo comparator | This arm was 4 weeks long. Placebo patch was initiated using a 12.5 cm patch and then increased to the largest tolerated patch size during the first 2 weeks and held steady the last two weeks. Subjects were seen weekly, phone contact was made between visits and dosing could be adjusted as a result of the phone visit. Receives: Other: placebo patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wender Reimherr Adult Attention Deficit Disorder Scale
This scale measures the 7 domains of the Utah Criteria for Adult ADHD. Total scores run from 0 to 28. Normative samples average below 5. The worst possible score is 28.
Measured: Double-blind endpoints during MTS and placebo arms
Secondary outcomes (1)
Conners' Adult ADHD Rating Scales (CAARS)
Measures the DSM based ADHD criteria of Inattention and Hyperactivity/Impulsivity. There are 30 items scored 0-3 for a minimum score of 0 (no symptoms) and a maximum score of 90 worst possible symptoms.
Measured: Double-blind endpoints for MTS and placebo arms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Shire
- Responsible party
- Principal investigator, frederick reimherr, University of Utah
- Investigators
- Frederick W. Reimherr, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506285
- Sponsor's protocol ID
- 20405
- Other IDs
- SPD485.420-Reimherr
- Status last verified
- Jan 2015
- First submitted
- 23 Jul 2007
- Last updated
- 16 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Olsen JL, Reimherr FW, Marchant BK, Wender PH, Robison RJ. The effect of personality disorder symptoms on response to treatment with methylphenidate transdermal system in adults with attention-deficit/hyperactivity disorder. Prim Care Companion CNS Disord. 2012;14(5):PCC.12m01344. doi: 10.4088/PCC.12m01344. Epub 2012 Oct 11.
PubMed 23469326Reimherr FW, Marchant BK, Olsen JL, Wender PH, Robison RJ. Oppositional defiant disorder in adults with ADHD. J Atten Disord. 2013 Feb;17(2):102-13. doi: 10.1177/1087054711425774. Epub 2011 Nov 18.
PubMed 22100691Gift TE, Reimherr FW, Marchant BK, Steans TA, Wender PH. Personality Disorder in Adult Attention-Deficit/Hyperactivity Disorder: Attrition and Change During Long-term Treatment. J Nerv Ment Dis. 2016 May;204(5):355-63. doi: 10.1097/NMD.0000000000000470.
PubMed 27082828
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylphenidate Transdermal System (MTS) in the Treatment of Adult ADHD
- ClinicalTrials.gov ID
- NCT00506285
- Acronym / sponsor ID
- 20405
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder, ADHD, Adult, Methylphenidate Transdermal System, Daytrana
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Shire
- Study start
- Jun 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 25 Jul 2007 (estimated)
- Results
- Posted 16 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look at the effectiveness of Methylphenidate Transdermal System (MTS) in treating adult ADHD. MTS has received FDA approval for childhood ADHD but this is the first trial for adult ADHD. Subjects will experience two screening visits and one baseline visit. Those who meet admission criteria will enter the double-blind phase. This will involve two 4-week treatment periods one of which will involve the use of MTS and the other a placebo patch. Subjects who complete the double-blind phase will be allowed to enter a 180-day, open-label MTS phase designed to assess long-term effects.
Detailed description
ADHD affects from 3 to 5% of children, persists into adolescence in 40 to 70% of these children and continues into adulthood in at least 50% of affected adolescents. Methylphenidate was the first medication shown to be effective in treatment for adults with ADHD and continues to be widely used. While the extended release formulations represent an improvement over the immediate release versions, significant problems remain for many patients. In particular, most have been designed with the goal of providing medication only during school hours and a short time period after school. In adults, there is a frequent need for much more extended duration of treatment. MTS is a new form of methylphenidate that provides medication in a transdermal patch delivery system. It has a very even, slowly ascending pharmacokinetic profile. MTS's very stable slowly increasing blood level should overcome the problems noted above with a delivery system that is more convenient for many patients. It is currently approved for treatment of childhood ADHD, with effectiveness and safety profiles similar to other forms of methylphenidate. This study will be the first to evaluate the effectiveness and safety of MTS in adult ADHD.
This is a double-blind, placebo-controlled, randomized, crossover trial comparing MTS with placebo patch. The double-blind trial will be preceded by an enrollment period consisting of two screening visits followed as quickly as possible by a baseline visit. Patients who continue to meet admission criteria at baseline will be randomized into the first of two 4-week treatment periods. We will attempt to reach the highest tolerated dose size of MTS within 2 weeks and then observe the response over the last two weeks of each crossover phase. The double-blind period will be followed by a 180 day open-treatment, flexible-dose phase designed to assess long-term effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Methylphenidate Transdermal System (MTS)This arm was 4 weeks long. Subjects were treated using Methylphenidate Transdermal System. Patients were seen weekly, phone contact was made between visits and dosing could be adjusted as a result of the phone contact. MTS was initiated using a 12.5 cm patch. The dose was increased during the first 2 weeks based on treatment response and side effects to the largest tolerated dose/patch size. It was held steady the last 2 weeks. |
| B | Placebo comparator | Other: placebo patchThis arm was 4 weeks long. Placebo patch was initiated using a 12.5 cm patch and then increased to the largest tolerated patch size during the first 2 weeks and held steady the last two weeks. Subjects were seen weekly, phone contact was made between visits and dosing could be adjusted as a result of the phone visit. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults meeting DSM-IV-Text Revision criteria for ADHD, the Utah Criteria for ADHD, and experiencing at least moderate impairment (a score of 4 or greater on the CGI-Severity Scale for ADHD at both Screening and Baseline visits) will be enrolled. Other criteria include:
- Subjects ages 18 to 65, inclusive;
- Female subjects are eligible to enter and participate in this study only if:
- Subject must be in general good health as determined by medical history, ECG, and other analysis that, in the judgment of the study physician, would confirm the patient's good health.
- Subjects must read and write at a level sufficient to provide written informed consent and complete study-related materials.
Key exclusion criteria (13 listed)
- Subjects will not be eligible for inclusion in this study if any of the following criteria apply:
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 Transdermal System (MTS)Also: DaytranaMTS is an advanced patch product that provides methylphenidate evenly mixed with the adhesive. This formulation allows good adhesion and a wide range of dose sizes. MTS patch sizes of 12.5, 18.75, 25 and 37.5cm2 are equivalent to nominal doses over a 9-hour wear time of 10, 15, 20 and 30mg of MPH. | Drug | A |
| placebo patchThis patch is designed to appear identical to the actual intervention patch | Other | B |
Primary outcome
Wender Reimherr Adult Attention Deficit Disorder Scale
Time frame: Double-blind endpoints during MTS and placebo arms
This scale measures the 7 domains of the Utah Criteria for Adult ADHD. Total scores run from 0 to 28. Normative samples average below 5. The worst possible score is 28.
1 secondary outcome
Conners' Adult ADHD Rating Scales (CAARS)
Time frame: Double-blind endpoints for MTS and placebo arms
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23469326Olsen JL, Reimherr FW, Marchant BK, Wender PH, Robison RJ. The effect of personality disorder symptoms on response to treatment with methylphenidate transdermal system in adults with attention-deficit/hyperactivity disorder. Prim Care Companion CNS Disord. 2012;14(5):PCC.12m01344. doi: 10.4088/PCC.12m01344. Epub 2012 Oct 11.
- Results publication: PubMed 22100691Reimherr FW, Marchant BK, Olsen JL, Wender PH, Robison RJ. Oppositional defiant disorder in adults with ADHD. J Atten Disord. 2013 Feb;17(2):102-13. doi: 10.1177/1087054711425774. Epub 2011 Nov 18.
- Derived from this study: PubMed 27082828Gift TE, Reimherr FW, Marchant BK, Steans TA, Wender PH. Personality Disorder in Adult Attention-Deficit/Hyperactivity Disorder: Attrition and Change During Long-term Treatment. J Nerv Ment Dis. 2016 May;204(5):355-63. doi: 10.1097/NMD.0000000000000470.
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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.
Frederick W. Reimherr, MD principal investigator
University of Utah
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 Transdermal System (MTS) in people with Attention Deficit Hyperactivity Disorder, run by University of Utah at 1 site in United States.
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 7 inclusion and 13 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 16 Jan 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 United States. 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?
Yes. Results are posted in the registry (first posted 16 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (time frame: Double-blind endpoints during MTS and placebo arms). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00506285, which also lists 3 linked publications.
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 16 Jan 2015.