ADHDPhase 4NCT00181571
A Double-Blind Comparison of Concerta and Placebo in Adults With Attention Deficit Hyperactivity Disorder
A Phase 4 study testing methylphenidate HCl (Concerta) in people with ADHD, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is a double-blind, placebo-controlled study using daily doses of up to 1.3 mg/kg/day of Concerta in the treatment of adults with the DSM-IV diagnosis of attention deficit hyperactivity disorder (ADHD) (childhood onset). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- ADHD
- What is being tested?
- methylphenidate HCl (Concerta)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 297 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Aug 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
- Male and female outpatients older than 18 and younger than 55 years of age.
- Subjects with the diagnosis of attention deficit hyperactivity disorder (ADHD), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview.
- ADHD Symptom Checklist score > 24.
- Patients with past history of depression, bipolar disorder, anxiety disorder (including OCD) without current disorder for > 3 months as ascertained through structured diagnostic interview and clinical exam.
- Subjects treated for anxiety disorders 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 scales below 15 (mild range).
- Subjects with a past history of tics but tic free for > 1 year.
- Subjects with past history of substance use disorders but substance free for > 6 months.
- Subjects receiving non-MAOI antidepressants (e.g., SSRI's, bupropion, venlafaxine) or benzodiazepines who have been on a stable regimen for > 3 months for any of the conditions listed above.
Who cannot join
- Any clinically unstable psychiatric conditions including the following: acute psychosis, acute panic, acute OCD, acute mania, acute suicidality, bipolar disorder, acute substance use disorders (alcohol or drugs, sociopathy, criminality, or delinquency.
- Any metabolic, neurological, hepatic, renal, cardiovascular, hematological, opthalmic, or endocrine disease.
- Clinically significant abnormal baseline laboratory values which include the following:
- Values > 20% above the upper range of the laboratory standard of a basic metabolic screen.
- Exclusionary blood pressure > 140 (systolic) and 90 (diastolic).
- Exclusionary ECG parameters: QTC > 460 msec, QRS > 120 msec, and PR > 200 msec. Subjects having ECG evidence of ischemia or arrhythmia as reviewed by an independent cardiologist.
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- Mental retardation (IQ <75).
- Organic brain disorders.
- Seizures or tics in the last year.
- Pregnant or nursing females.
- Subjects with current adequate treatment for ADHD or a history of a previous adequate trial of Concerta.
- Non-English speaking subjects will not be allowed into the study for the following reasons:
- the assessment instruments are unavailable and have not been adequately standardized in other languages;
- our clinical trials facility is located in Cambridge and not at the MGH main campus; thus translators are unavailable;
- even if such translation services were available, the assessments in the English language conducted by English-speaking clinicians and raters with English-speaking subjects are 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;
- 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 double-blind, placebo-controlled study using daily doses of up to 1.3 mg/kg/day of Concerta in the treatment of adults with the DSM-IV diagnosis of attention deficit hyperactivity disorder (ADHD) (childhood onset). We hypothesize ADHD symptomatology in adults with DSM-IV ADHD will be responsive to Concerta treatment and Concerta-associated response of ADHD symptomatology in adults will be sustained over time.
Read the detailed description
Concerta was specially developed to replace three-times-a-day IR methylphenidate, making it an ideal option for patients with ADHD. Moreover, the once-a-day administration of Concerta secures a steady delivery of methylphenidate across the day, minimizing the well-known risks of peaks and valleys of IR methylphenidate, which could offer an added advantage to the pharmacokinetic advantage of once-a-day administration. Despite these putative advantages, whether this new delivery system will lead to the same results as those documented with immediate-response methylphenidate in the treatments of adults with ADHD requires empirical corroboration. To this end we are conducting a randomized controlled clinical trial to evaluate the short- and medium-term safety and efficacy of Concerta in the treatment of adults with ADHD with and without co-morbid psychiatric disorders. We also wish to examine the role of genetics in predicting ADHD treatment response to Concerta. There is growing literature that supports the role of genetic factors in treatment response in youth with ADHD, and we seek to further explore this relationship in adults.
The proposed study includes the use of a 34-week design to document the response rate, assessment of the impact of Concerta on functional capacities (quality of life, psychosocial function) and cognition, and careful assessment of safety and tolerability.
- Conditions
- ADHD
- Being tested
- methylphenidate HCl (Concerta), Placebo
- Keywords
- ADHD, Adults, Concerta, Double-Blind
- 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 HCl (Concerta)Drug
Also called Concerta
up to a maximum dose of 1.3 mg Concerta/kg/day, and not more than 144 mg/day for any subject regardless of weight.
PlaceboDrug
up to a maximum dose of 1.3 mg Placebo /kg/day, and not more than 144 mg/day for any subject regardless of weight.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Concerta Receives: Drug: methylphenidate HCl (Concerta) |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom reduction using ADHD-Clinical Global Impression and ADHD Symptom Checklist Severity scale administered at each visit.
Measured: 34 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 2003
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 297 participants (actual)
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.
- Responsible party
- Principal investigator, Joseph Biederman, MD, Massachusetts General Hospital
- Investigators
- Joseph Biederman, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181571
- Sponsor's protocol ID
- 2003-p-000037
- Status last verified
- Jun 2013
- First submitted
- 13 Sep 2005
- Last updated
- 27 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Biederman J, Mick E, Fried R, Wilner N, Spencer TJ, Faraone SV. Are stimulants effective in the treatment of executive function deficits? Results from a randomized double blind study of OROS-methylphenidate in adults with ADHD. Eur Neuropsychopharmacol. 2011 Jul;21(7):508-15. doi: 10.1016/j.euroneuro.2010.11.005. Epub 2011 Mar 9.
PubMed 21303732
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Comparison of Concerta and Placebo in Adults With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT00181571
- Acronym / sponsor ID
- 2003-p-000037
- Conditions
- ADHD
- Keywords
- ADHD, Adults, Concerta, Double-Blind
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
- Study start
- Jun 2003
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 16 Sep 2005 (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 double-blind, placebo-controlled study using daily doses of up to 1.3 mg/kg/day of Concerta in the treatment of adults with the DSM-IV diagnosis of attention deficit hyperactivity disorder (ADHD) (childhood onset). We hypothesize ADHD symptomatology in adults with DSM-IV ADHD will be responsive to Concerta treatment and Concerta-associated response of ADHD symptomatology in adults will be sustained over time.
Detailed description
Concerta was specially developed to replace three-times-a-day IR methylphenidate, making it an ideal option for patients with ADHD. Moreover, the once-a-day administration of Concerta secures a steady delivery of methylphenidate across the day, minimizing the well-known risks of peaks and valleys of IR methylphenidate, which could offer an added advantage to the pharmacokinetic advantage of once-a-day administration. Despite these putative advantages, whether this new delivery system will lead to the same results as those documented with immediate-response methylphenidate in the treatments of adults with ADHD requires empirical corroboration. To this end we are conducting a randomized controlled clinical trial to evaluate the short- and medium-term safety and efficacy of Concerta in the treatment of adults with ADHD with and without co-morbid psychiatric disorders. We also wish to examine the role of genetics in predicting ADHD treatment response to Concerta. There is growing literature that supports the role of genetic factors in treatment response in youth with ADHD, and we seek to further explore this relationship in adults.
The proposed study includes the use of a 34-week design to document the response rate, assessment of the impact of Concerta on functional capacities (quality of life, psychosocial function) and cognition, and careful assessment of safety and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: methylphenidate HCl (Concerta)Concerta |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male and female outpatients older than 18 and younger than 55 years of age.
- Subjects with the diagnosis of attention deficit hyperactivity disorder (ADHD), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview.
- ADHD Symptom Checklist score > 24.
- Patients with past history of depression, bipolar disorder, anxiety disorder (including OCD) without current disorder for > 3 months as ascertained through structured diagnostic interview and clinical exam.
- Subjects treated for anxiety disorders 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 scales below 15 (mild range).
Key exclusion criteria (16 listed)
- Any clinically unstable psychiatric conditions including the following: acute psychosis, acute panic, acute OCD, acute mania, acute suicidality, bipolar disorder, acute substance use disorders (alcohol or drugs, sociopathy, criminality, or delinquency.
- Any metabolic, neurological, hepatic, renal, cardiovascular, hematological, opthalmic, or endocrine disease.
- Clinically significant abnormal baseline laboratory values which include the following:
- Mental retardation (IQ <75).
- Organic brain disorders.
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 HCl (Concerta)Also: Concertaup to a maximum dose of 1.3 mg Concerta/kg/day, and not more than 144 mg/day for any subject regardless of weight. | Drug | 1 |
| Placeboup to a maximum dose of 1.3 mg Placebo /kg/day, and not more than 144 mg/day for any subject regardless of weight. | Drug | 2 |
Primary outcome
Symptom reduction using ADHD-Clinical Global Impression and ADHD Symptom Checklist Severity scale administered at each visit.
Time frame: 34 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 27 Jun 2013.
- Derived from this study: PubMed 21303732Biederman J, Mick E, Fried R, Wilner N, Spencer TJ, Faraone SV. Are stimulants effective in the treatment of executive function deficits? Results from a randomized double blind study of OROS-methylphenidate in adults with ADHD. Eur Neuropsychopharmacol. 2011 Jul;21(7):508-15. doi: 10.1016/j.euroneuro.2010.11.005. Epub 2011 Mar 9.
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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.
Joseph Biederman, 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 HCl (Concerta) in people with ADHD, 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 8 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 27 Jun 2013. 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 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?
Symptom reduction using ADHD-Clinical Global Impression and ADHD Symptom Checklist Severity scale administered at each visit. (time frame: 34 weeks). 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 NCT00181571, which also lists 1 linked publication.
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 27 Jun 2013.