Attention Deficit Hyperactivity DisorderPhase 4NCT00302406
Naturalistic Substitution of Concerta in Adult Subject With ADHD Receiving Immediate Release Methylphenidate
A Phase 4 study testing methylphenidate hydrochloride and OROS methylphenidate hydrochloride (CONCERTA) in people with Attention Deficit Hyperactivity Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is a single-blind study looking at the efficacy and satisfaction of Concerta substitution in adult subjects with ADHD receiving immediate release methylphenidate. Subjects will be administered a maximum dose of 1.3mg/kg/day of either methylphenidate or Concerta. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- methylphenidate hydrochloride and OROS methylphenidate hydrochloride (CONCERTA)
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Nov 2007
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed written informed consent to participate in the study.
- Male and female outpatients older than 18 and younger than 55 years of age.
- If female, non-pregnant, non-nursing with a negative urine pregnancy test and using medically accepted means of birth control (abstinence, birth control pills, IUD, barrier devices, or progesterone rods stabilized for at least three months) while in this study.
- Responders to methylphenidate IR on stable treatment (Stable treatment is defined as a score on the NIMH CGI improvement scale of much or very improved (compared to pre-treatment) from a period of 4 weeks on a stable dose of MPH IR TID).
- Responders to methylphenidate IR on stable treatment who are satisfied with their treatment (satisfaction with treatment is defined as a score of 1 or 2 on the Treatment Satisfaction Rating scale from a period of 4 weeks on a stable dose of MPH IR TID).
- Responders to methylphenidate IR on stable treatment who tolerate their treatment (toleration of treatment is defined as a score on the Tolerability Index of 0 or 1) from a period of 4 weeks on a stable dose of MPH IR TID).
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- Mild cases of asthma and allergy.
- Acid reflux syndrome.
- Hypercholesterolemia.
- Subjects with a past history of tics but tic free for > 1 year.
- Subjects with past history of depression, anxiety disorder (including OCD) without current disorder for > 6 months as ascertained through structured diagnostic interview and clinical exam.
- Subjects treated for anxiety disorders (including OCD), and depression who are on a stable medication regimen for at least three months, and who have a disorder specific CGI-severity score ≤ 3 (mildly ill) and who have a score on the Hamilton-Depression and Hamilton-anxiety rating scale below 15 (mild range) will be included in the study.
- Subjects receiving non-MAOI antidepressants (e.g., SSRI's, venlafaxine), benzodiazepines, on a stable regimen for > 3 months for any of the conditions listed above.
Who cannot join
- Diagnosis of, or family history of Tourette's syndrome, or Autism.
- History of seizures.
- Subjects with history of tics in the past year.
- Subjects with a known recent history (within the past six (6) months) of illicit drug or alcohol dependence.
- Any clinically unstable psychiatric conditions including the following: bipolar disorder, acute psychosis, acute panic, acute OCD, acute mania, acute suicidality, acute substance use disorders (alcohol or drugs), acute OCD, sociopathy, criminality or delinquency.
- Subjects currently (within the past 4 weeks) receiving bupropion.
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- Any metabolic, neurological, hepatic, renal, cardiovascular, hematological, opthalmic, or endocrine disease.
- Clinically significant abnormal baseline laboratory values, which include the following:
- Values larger than 20% above the upper range of the laboratory standard of a basic metabolic screen.
- Exclusionary blood pressure parameters will include any values above 140 (systolic) and 90 (diastolic).
- Exclusionary ECG parameters will include a QTC> 460msec, QRS>120 msec, and PR>200 msec. Any subject having ECG evidence of ischemia or arrhythmia as reviewed by an independent cardiologist.
- Organic brain disorders.
- Mental impairment as evidenced by an I.Q. <70 as determined by an abbreviated version of the Wechsler Adult Intelligence Scales (Wechsler Adult Intelligence Scales-Revised (WAIS-III) and the Wide Range Achievement Test (WRAT-III).
- Pregnancy or lactation.
- Glaucoma.
- Non English speaking subjects will not be allowed into the study for the following reasons: a) the assessment instruments are not available and have not been adequately standardized in other languages; b) our clinical trials facility is located in Cambridge and not in the MGH main campus without the availability of translators; and c) even if such translation services were to be available, the assessments in the English language conducted by English speaking clinicians and raters with English speaking subjects is already extremely time consuming lasting many hours making it unfeasible, unrealistic, and of dubious clinical validity to conduct them with a translator with non English speaking subjects; d) psychiatric questionnaires and evaluations are taxing and adding the complexity of a translator has the potential to make the patient experience even more exhausting.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Cambridge, Massachusetts, 02138
About this study
This is a single-blind study looking at the efficacy and satisfaction of Concerta substitution in adult subjects with ADHD receiving immediate release methylphenidate. Subjects will be administered a maximum dose of 1.3mg/kg/day of either methylphenidate or Concerta. The specific hypotheses of this study are:
Hypothesis 1: ADHD symptomatology in adults with DSM-IV, ADHD will continue to be controlled in patients switched from MPH IR TID to Concerta.
Hypothesis 2: Patient satisfaction will not decrease in patients switched from MPH IR TID to Concerta (ie., all patients will be equally or more satisfied on Concerta as compared with MPH IR TID.
Read the detailed description
Concerta was specifically developed to replace three times a day immediate release (IR) methylphenidate (MPH). The clinical advantages offered by this novel compound go beyond ease of administration. By avoiding the peaks and valleys of serum levels associated with IR MPH, treatment with Concerta minimizes adverse effects at peaks and break through symptoms at valleys securing clinical coverage throughout the day, minimizing the risks of adverse effects from serum fluctuations that can occur with multiple dosing of the IR formulation of MPH. This unique pharmacokinetic and pharmacodynamic profile of Concerta is potentially particularly advantageous in the treatment of adults with ADHD because a) adults with ADHD tend to be forgetful; b) forgetfulness makes the self administration of treatment three times a day difficult; c) forgetfulness can lead to poor compliance and drop off of effects over time with its attendant detrimental effect on clinical control and quality of life. Subjects will be randomized by the pharmacy to CONCERTA or to continue MPH IR TID in a ratio of 4:1.
This study includes: 1) a six-week design to document the response rate 2) assessment of the impact of either MPH IR or Concerta on functional capacities 3) careful assessment of safety and tolerability
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- methylphenidate hydrochloride, OROS methylphenidate hydrochloride (CONCERTA)
- 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
OROS methylphenidate hydrochloride (CONCERTA)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcomes: maintenance of symptom control when switched from TID IR MPH to Concerta administered once a day in the AM and to assess if this differs from 100%, the value one would expect if Concerta maintained efficacy in all subjects.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2006 (estimated)
- Study startJul 2003
- Primary completionNov 2007
- Study completionNov 2007
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.
- More trials run by Massachusetts General HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
- Investigators
- Thomas Spencer, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302406
- Sponsor's protocol ID
- 2003-P-000038
- Status last verified
- Jul 2011
- First submitted
- 10 Mar 2006
- Last updated
- 12 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naturalistic Substitution of Concerta in Adult Subject With ADHD Receiving Immediate Release Methylphenidate
- ClinicalTrials.gov ID
- NCT00302406
- Acronym / sponsor ID
- 2003-P-000038
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
- Study start
- Jul 2003
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 14 Mar 2006 (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 is a single-blind study looking at the efficacy and satisfaction of Concerta substitution in adult subjects with ADHD receiving immediate release methylphenidate. Subjects will be administered a maximum dose of 1.3mg/kg/day of either methylphenidate or Concerta. The specific hypotheses of this study are:
Hypothesis 1: ADHD symptomatology in adults with DSM-IV, ADHD will continue to be controlled in patients switched from MPH IR TID to Concerta.
Hypothesis 2: Patient satisfaction will not decrease in patients switched from MPH IR TID to Concerta (ie., all patients will be equally or more satisfied on Concerta as compared with MPH IR TID.
Detailed description
Concerta was specifically developed to replace three times a day immediate release (IR) methylphenidate (MPH). The clinical advantages offered by this novel compound go beyond ease of administration. By avoiding the peaks and valleys of serum levels associated with IR MPH, treatment with Concerta minimizes adverse effects at peaks and break through symptoms at valleys securing clinical coverage throughout the day, minimizing the risks of adverse effects from serum fluctuations that can occur with multiple dosing of the IR formulation of MPH. This unique pharmacokinetic and pharmacodynamic profile of Concerta is potentially particularly advantageous in the treatment of adults with ADHD because a) adults with ADHD tend to be forgetful; b) forgetfulness makes the self administration of treatment three times a day difficult; c) forgetfulness can lead to poor compliance and drop off of effects over time with its attendant detrimental effect on clinical control and quality of life. Subjects will be randomized by the pharmacy to CONCERTA or to continue MPH IR TID in a ratio of 4:1.
This study includes: 1) a six-week design to document the response rate 2) assessment of the impact of either MPH IR or Concerta on functional capacities 3) careful assessment of safety and tolerability
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Signed written informed consent to participate in the study.
- Male and female outpatients older than 18 and younger than 55 years of age.
- If female, non-pregnant, non-nursing with a negative urine pregnancy test and using medically accepted means of birth control (abstinence, birth control pills, IUD, barrier devices, or progesterone rods stabilized for at least three months) while in this study.
- Responders to methylphenidate IR on stable treatment (Stable treatment is defined as a score on the NIMH CGI improvement scale of much or very improved (compared to pre-treatment) from a period of 4 weeks on a stable dose of MPH IR TID).
- Responders to methylphenidate IR on stable treatment who are satisfied with their treatment (satisfaction with treatment is defined as a score of 1 or 2 on the Treatment Satisfaction Rating scale from a period of 4 weeks on a stable dose of MPH IR TID).
Key exclusion criteria (16 listed)
- Diagnosis of, or family history of Tourette's syndrome, or Autism.
- History of seizures.
- Subjects with history of tics in the past year.
- Subjects with a known recent history (within the past six (6) months) of illicit drug or alcohol dependence.
- Any clinically unstable psychiatric conditions including the following: bipolar disorder, acute psychosis, acute panic, acute OCD, acute mania, acute suicidality, acute substance use disorders (alcohol or drugs), acute OCD, sociopathy, criminality or delinquency.
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 hydrochloride | Drug | – |
| OROS methylphenidate hydrochloride (CONCERTA) | Drug | – |
Primary outcome
Primary Outcomes: maintenance of symptom control when switched from TID IR MPH to Concerta administered once a day in the AM and to assess if this differs from 100%, the value one would expect if Concerta maintained efficacy in all subjects.
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 12 Jul 2011.
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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.
Thomas Spencer, MD principal investigator
Massachusetts General Hospital
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 methylphenidate hydrochloride and OROS methylphenidate hydrochloride (CONCERTA) in people with Attention Deficit Hyperactivity Disorder, run by Massachusetts General Hospital 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 13 inclusion and 16 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 12 Jul 2011. 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. 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 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?
Primary Outcomes: maintenance of symptom control when switched from TID IR MPH to Concerta administered once a day in the AM and to assess if this differs from 100%, the value one would expect if Concerta maintained efficacy in all subjects.. 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 12 Jul 2011.