Attention Deficit Hyperactivity DisorderPhase 2/3NCT02215538
OROS Methylphenidate (Concerta) in the Treatment of Adult ADHD
A Phase 2/3 study testing OROS methylphenidate 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 osmotic release oral system (OROS) methylphenidate (Concerta) in treating attention deficit hyperactvity disorder (ADHD) in adults. Concerta has received FDA approval for childhood ADHD and there is documentation that it is effective in adult ADHD. 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?
- OROS methylphenidate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Jun 2006
- Phase
- Phase 2/3
- 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
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 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;
- 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;
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- 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, chronic obstructive pulmonary disease, 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);
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Concerta in the Treatment of Adult ADHD and a Comparison of Four Adult ADHD Scales and Effects on Personality
This study will look at the effectiveness of osmotic release oral system (OROS) methylphenidate (Concerta) in treating attention deficit hyperactvity disorder (ADHD) in adults. Concerta has received FDA approval for childhood ADHD and there is documentation that it is effective in adult ADHD. However this trial will explore its effectiveness in treating symptoms not a part of the Diagnostic and Statistical Manual-III (DSM-III) criteria. Subjects will experience one screening visit 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 Concerta and the other a placebo pill. Subjects who complete the double-blind phase will be allowed to enter a 180-day, open-label Concerta phase designed to assess long-term effects.
Read the detailed description
ADHD affects from 3 to 5% of children, persists into adolescence 40 to 70% of these children and continues into adulthood in at least 50% of affected adolescents. Pharmacotherapy for ADHD in adults has paralleled that used for children, with generally positive results (Spencer, 1998). Never-the-less, it is not clear that the dimensions of medication response in adults are the same as in children. The extent to which the symptoms change with age remains open to question. This trial is created to include a variety of outcome measures which will enhance the number of symptoms assessed.
Methylphenidate was the first medication shown to be effective in treatment for adults with ADHD and continues to be widely used. Several studies have demonstrated the usefulness of methylphenidate in adult ADHD (Wender et al, 1985, Spencer et al, 1995). These studies have not shown any unexpected drawbacks to treatment with methylphenidate. The extended release formulations represent an improvement over the immediate release versions for many patients.
This is a double-blind, placebo-controlled, randomized, crossover trial comparing OROS methylphenidate with placebo. The double-blind trial will be preceded by an enrollment period consisting of a screening visit followed 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 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
- OROS methylphenidate, Placebo
- Keywords
- ADHD, adult, WRAADDS, OROS MPH, emotional dysregulation
- 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.
OROS methylphenidateDrug
Also called concerta
PlaceboDrug
Placebo medication appears identical to the active medication OROS methylphenidate
| Study group | Role | What they receive |
|---|---|---|
| OROS methylphenidate | Experimental | This was a 4-week double-blind arm. Medication was initiated at 18 mg/day and increased every 2 or 3 days by 9 mg based on treatment response and side effects. Maximum dose - 90 mg/day. Patients were seen weekly. Generally a stable dose was seen in 2 weeks and maintained the last 2 weeks of the arm. Side effects were assessed at each visit. Receives: Drug: OROS methylphenidate |
| placebo | Placebo comparator | This arm was identical to the active medication arm except that placebo replaced the active medication. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS)
This is an investigator rated scale which assessed the 7 domains of the Utah Criteria of Adult ADHD
Measured: Baseline visit, Double-blind phase Week 4 each arm, Open-Label months 1-6
Secondary outcomes (5)
Clinical Global Impressions-Improvement (CGI-I)
This is a global measure in improvement in symptoms that is a Likert type scale
Measured: Baseline; Double-blind phase Week 4 each arm: Open-Label months 1-6
Clinical Global Impression - Severity (CGI-S)
This is a general measure of symptom severity assessed using a Likert type scale.
Measured: Baseline visit; Double-blind phase Week 4 each arm: Open-Label months 1-6
ADHD rating scale (ADHD-RS)
This is an investigator rated scale which assesses the DSM-IV symptoms.
Measured: Baselinevisit; Double-blind phase Week 4 each arm: Open-Label final visit month 6
Self Report Wender-Reimherr Adult Attention Deficit Disorder Scale (SR-WRAADDS)
This is a patient rated scale that assesses the 7 domains of the Utah Criteria for adult ADHD as well as ODD, Social functioning and Learning difficulties.
Measured: Baseline; Double-blind phases Week 4 each arm: Final visit of Open-Label period month 6
Wisconsin Personality Inventory - IV (WISPI-IV)
This is a computerized personality inventory completed by the patients. It consists of 214 items which address the 10 DSM-IV personality disorders plus passive aggressive personality disorder.
Measured: Baseline visit; Final Open-Label visit month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startNov 2004
- Primary completionFeb 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
- Responsible party
- Principal investigator, frederick reimherr, University of Utah
- Investigators
- Frederick W Reimherr, MD, Principal investigator, Univeristy of Utah Dept of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215538
- Sponsor's protocol ID
- 00012246
- Status last verified
- Aug 2014
- First submitted
- 8 Aug 2014
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Marchant BK, Reimherr FW, Halls C, Williams ED, Strong RE. OROS methylphenidate in the treatment of adults with ADHD: a 6-month, open-label, follow-up study. Ann Clin Psychiatry. 2010 Aug;22(3):196-204.
PubMed 20680193Reimherr FW, Marchant BK, Williams ED, Strong RE, Halls C, Soni P. Personality disorders in ADHD Part 3: Personality disorder, social adjustment, and their relation to dimensions of adult ADHD. Ann Clin Psychiatry. 2010 May;22(2):103-12.
PubMed 20445837Robison RJ, Reimherr FW, Gale PD, Marchant BK, Williams ED, Soni P, Halls C, Strong RE. Personality disorders in ADHD Part 2: The effect of symptoms of personality disorder on response to treatment with OROS methylphenidate in adults with ADHD. Ann Clin Psychiatry. 2010 May;22(2):94-102.
PubMed 20445836Williams ED, Reimherr FW, Marchant BK, Strong RE, Halls C, Soni P, Gale PD, Robison RJ. Personality disorder in ADHD Part 1: Assessment of personality disorder in adult ADHD using data from a clinical trial of OROS methylphenidate. Ann Clin Psychiatry. 2010 May;22(2):84-93.
PubMed 20445835Reimherr FW, Williams ED, Strong RE, Mestas R, Soni P, Marchant BK. A double-blind, placebo-controlled, crossover study of osmotic release oral system methylphenidate in adults with ADHD with assessment of oppositional and emotional dimensions of the disorder. J Clin Psychiatry. 2007 Jan;68(1):93-101. doi: 10.4088/jcp.v68n0113.
PubMed 17284136Gift 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 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concerta in the Treatment of Adult ADHD and a Comparison of Four Adult ADHD Scales and Effects on Personality
- ClinicalTrials.gov ID
- NCT02215538
- Acronym / sponsor ID
- 00012246
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, adult, WRAADDS, OROS MPH, emotional dysregulation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
- Study start
- Nov 2004
- Primary completion
- Feb 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 13 Aug 2014 (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 will look at the effectiveness of osmotic release oral system (OROS) methylphenidate (Concerta) in treating attention deficit hyperactvity disorder (ADHD) in adults. Concerta has received FDA approval for childhood ADHD and there is documentation that it is effective in adult ADHD. However this trial will explore its effectiveness in treating symptoms not a part of the Diagnostic and Statistical Manual-III (DSM-III) criteria. Subjects will experience one screening visit 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 Concerta and the other a placebo pill. Subjects who complete the double-blind phase will be allowed to enter a 180-day, open-label Concerta phase designed to assess long-term effects.
Detailed description
ADHD affects from 3 to 5% of children, persists into adolescence 40 to 70% of these children and continues into adulthood in at least 50% of affected adolescents. Pharmacotherapy for ADHD in adults has paralleled that used for children, with generally positive results (Spencer, 1998). Never-the-less, it is not clear that the dimensions of medication response in adults are the same as in children. The extent to which the symptoms change with age remains open to question. This trial is created to include a variety of outcome measures which will enhance the number of symptoms assessed.
Methylphenidate was the first medication shown to be effective in treatment for adults with ADHD and continues to be widely used. Several studies have demonstrated the usefulness of methylphenidate in adult ADHD (Wender et al, 1985, Spencer et al, 1995). These studies have not shown any unexpected drawbacks to treatment with methylphenidate. The extended release formulations represent an improvement over the immediate release versions for many patients.
This is a double-blind, placebo-controlled, randomized, crossover trial comparing OROS methylphenidate with placebo. The double-blind trial will be preceded by an enrollment period consisting of a screening visit followed 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 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
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OROS methylphenidate | Experimental | Drug: OROS methylphenidateThis was a 4-week double-blind arm. Medication was initiated at 18 mg/day and increased every 2 or 3 days by 9 mg based on treatment response and side effects. Maximum dose - 90 mg/day. Patients were seen weekly. Generally a stable dose was seen in 2 weeks and maintained the last 2 weeks of the arm. Side effects were assessed at each visit. |
| placebo | Placebo comparator | Drug: PlaceboThis arm was identical to the active medication arm except that placebo replaced the active medication. |
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 (11 listed)
- 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;
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 |
|---|---|---|
| OROS methylphenidateAlso: concerta | Drug | OROS methylphenidate |
| PlaceboPlacebo medication appears identical to the active medication OROS methylphenidate | Drug | placebo |
Primary outcome
Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS)
Time frame: Baseline visit, Double-blind phase Week 4 each arm, Open-Label months 1-6
This is an investigator rated scale which assessed the 7 domains of the Utah Criteria of Adult ADHD
5 secondary outcomes
Clinical Global Impressions-Improvement (CGI-I)
Time frame: Baseline; Double-blind phase Week 4 each arm: Open-Label months 1-6
Clinical Global Impression - Severity (CGI-S)
Time frame: Baseline visit; Double-blind phase Week 4 each arm: Open-Label months 1-6
ADHD rating scale (ADHD-RS)
Time frame: Baselinevisit; Double-blind phase Week 4 each arm: Open-Label final visit month 6
Self Report Wender-Reimherr Adult Attention Deficit Disorder Scale (SR-WRAADDS)
Time frame: Baseline; Double-blind phases Week 4 each arm: Final visit of Open-Label period month 6
Wisconsin Personality Inventory - IV (WISPI-IV)
Time frame: Baseline visit; Final Open-Label visit month 6
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 13 Aug 2014.
- Results publication: PubMed 20680193Marchant BK, Reimherr FW, Halls C, Williams ED, Strong RE. OROS methylphenidate in the treatment of adults with ADHD: a 6-month, open-label, follow-up study. Ann Clin Psychiatry. 2010 Aug;22(3):196-204.
- Results publication: PubMed 20445837Reimherr FW, Marchant BK, Williams ED, Strong RE, Halls C, Soni P. Personality disorders in ADHD Part 3: Personality disorder, social adjustment, and their relation to dimensions of adult ADHD. Ann Clin Psychiatry. 2010 May;22(2):103-12.
- Results publication: PubMed 20445836Robison RJ, Reimherr FW, Gale PD, Marchant BK, Williams ED, Soni P, Halls C, Strong RE. Personality disorders in ADHD Part 2: The effect of symptoms of personality disorder on response to treatment with OROS methylphenidate in adults with ADHD. Ann Clin Psychiatry. 2010 May;22(2):94-102.
- Results publication: PubMed 20445835Williams ED, Reimherr FW, Marchant BK, Strong RE, Halls C, Soni P, Gale PD, Robison RJ. Personality disorder in ADHD Part 1: Assessment of personality disorder in adult ADHD using data from a clinical trial of OROS methylphenidate. Ann Clin Psychiatry. 2010 May;22(2):84-93.
- Results publication: PubMed 17284136Reimherr FW, Williams ED, Strong RE, Mestas R, Soni P, Marchant BK. A double-blind, placebo-controlled, crossover study of osmotic release oral system methylphenidate in adults with ADHD with assessment of oppositional and emotional dimensions of the disorder. J Clin Psychiatry. 2007 Jan;68(1):93-101. doi: 10.4088/jcp.v68n0113.
- 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
Univeristy of Utah Dept of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing OROS methylphenidate 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 11 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 13 Aug 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 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) (time frame: Baseline visit, Double-blind phase Week 4 each arm, Open-Label months 1-6). 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 NCT02215538, which also lists 6 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 13 Aug 2014; AzTrials last refreshed its copy on 8 Nov 2026.