Attention Deficit Hyperactivity Disorder (ADHD)Phase 4NCT01933880
A Long Term Post-Marketing Study on the EffIcacy and Safety of Osmotic Release Oral System (OROS) Methylphenidate on the Cognitive Functions of Attention Deficit Hyperactivity Disorder (ADHD) Participants
A Phase 4 study testing Osmotic Release Oral System Methylphenidate Hydrochloride (OROS-MPH) in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Xian-Janssen Pharmaceutical Ltd. at 6 sites in China.
Trial summary
The purpose of this long term post-marketing study is to evaluate the effectiveness and safety of osmotic release oral system methylphenidate hydrochloride (OROS-MPH) in participants with Attention Deficit Hyperactivity Disorder (ADHD). Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- Osmotic Release Oral System Methylphenidate Hydrochloride (OROS-MPH)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 6 sitesChina
- Study dates
- Dec 2009to Nov 2010
- Phase
- Phase 4
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ADHD children must sign the consent form in person, and their parents or guardian must endorse, in the consent form, participation of the child in the designated research program
- Through personal interaction and assessment questionnaire, examine to determine compliance of DSM-IV ADHD diagnostic criteria
- According to the judgment of researchers, the ADHD children should have normal intelligence. Normal intelligence is defined as no obvious evidence of mental retardation in general (specific learning disabilities will not be considered mental retardation in general), formal IQ test to be conducted and 85 marks or above ought to be scored
- ADHD children should not have been subjected to psychotropic drug treatment within 6 months. Those ADHD children on whom methylphenidate immediate-release tablets treatment is effective (with maximum daily dosage of 60 mg), may be admitted
- Normal children with IQ greater than or equal to 85
Who cannot join
- Unable to fully comply with the cognitive function test in the laboratory
- Known to be allergic to methylphenidate
- Consumption of psychoactive drugs currently or in the past 30 days, including use of monoamine oxidase inhibitors, clonidine, other alpha 2 adrenergic receptor agonists, tricyclic antidepressants, theophylline, bishydroxycoumarin etc
- History of alcohol, drugs or substances abuse
- Have medical history of type I or II bipolar affective disorder, anxiety disorder, schizophrenia or pervasive developmental disorder
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Study site
Beijing
Study site
Changchun
Study site
Guangzhou
Study site
Hangzhou
Study site
Shanghai
Study site
Shenzhen
About this study
Official title: An Open, Self-Controlled, Prospective Study of Concerta on Cognitive Functions, Efficacy and Tolerance in the Pediatric Patients With Attention Deficit Hyperactivity Disorder (ADHD)
The purpose of this long term post-marketing study is to evaluate the effectiveness and safety of osmotic release oral system methylphenidate hydrochloride (OROS-MPH) in participants with Attention Deficit Hyperactivity Disorder (ADHD).
Read the detailed description
This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), self-controlled, long-term post-marketing study in participants with ADHD. The study consists of 3 periods: screening period, wash-out period/run-in period (3 days), and open-label treatment period (12 weeks) which is divided into 2 periods that is dosage adjustment period and dose-optimization period. The total duration of the study is 12 weeks. During the dosage adjustment period, the dose of methylphenidate hydrochloride was adjusted to the optimal dose within 1-3 weeks starting with initial dosage of 18 milligram per day (mg/d) which can be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance. Participants will receive the optimal dose determined during dose adjustment period for 9 weeks during the dose-optimization period. In the study, 2 types of participants will be enrolled in 2 groups (according to condition): OROS-MPH group (participants with ADHD) and the normal children group (healthy participants). The efficacy will be assessed primarily by Digit Span Test and Inattention /Over activity With Aggression (IOWA) Conners evaluation scale. Participants' safety will be monitored throughout the study.
- Being tested
- Osmotic Release Oral System Methylphenidate Hydrochloride (OROS-MPH), No intervention
- Keywords
- Attention Deficit Hyperactivity Disorder, 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.
Osmotic Release Oral System Methylphenidate Hydrochloride (OROS-MPH)Drug
Osmotic release oral system methylphenidate hydrochloride (OROS-MPH) starting at initial dosage of 18 milligram per day (mg/d) which can be increased to 36mg/d up to a maximum dosage of 54mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18mg due to intolerance.
No interventionOther
Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
| Study group | Role | What they receive |
|---|---|---|
| OROS-MPH Group | Experimental | Participants with ADHD will receive OROS -MPH starting at initial dosage of 18 milligram per day (mg/d) which can be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance. Receives: Drug: Osmotic Release Oral System Methylphenidate Hydrochloride (OROS-MPH) |
| Normal Group | Active comparator | Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Digit Span Test Total Score at Week 12
The digit span test is mainly used to measure the ability of short-term memory and attention. The participant will be given a string of digits and asked to repeat them forward, and then a second string of digits to repeat backward. The score is the number of correct responses, where the digits were repeated correctly. One point will be given for each correctly repeated string of digits. The maximum subscore in the Digits Forward is 16, and the maximum subscore in the Digits Backward is 14, summed for a total score of 30. A higher score is indicative of better recall and attention.
Measured: Baseline and Week 12
Change From Baseline in Inattention/Overactivity With Aggression (IOWA) Conners Behavior Rating Scale - I/O Score at Week 1
IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.
Measured: Baseline and Week 1
Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 2
IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.
Measured: Baseline and Week 2
Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 3
IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.
Measured: Baseline and Week 3
Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 7
IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.
Measured: Baseline and Week 7
Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 12
IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.
Measured: Baseline and Week 12
Secondary outcomes (23)
Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale.
Remission rate is the percentage of participants with total score of IO sub-scale less than or equal to 5 in IOWA Conners measurement scale
Measured: End of Week 1, 2, 3, 7 and 12
Stroop Color Word Naming Test
This is a psychological test to observe the interference in which disparity between the meaning and color affects reading speed. A participant will be given 3 tasks of recognition: reading the printed colored ink (Color Test), reading color words in black ink (Word Test), and interference, reading color words printed in different colored ink (Word-Color Test). The test is scored on the number of correct answers. There are 100 items for each of the three categories and if they made it through the 100 words with time remaining, they would repeat the list. Median naming time in the Stroop color word naming test will be assessed. Stroop color word naming test 1 ,2 ,3 and 4 stand for gradually increased difficulty and each test has a corresponding baseline and endpoint.
Measured: Baseline and End of Week 12
Wisconsin Card Sorting Test (WCST): Administered Responses (Ra) of Completed Examination
WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. During number of trials administered or administered responses, participants were administered 128 cards and asked to sort the cards until all the 6 sorting categories was completed. Response number used to complete all 6 categories ranges from 50 to 128, lesser the better.
Measured: Baseline and End of Week 12
WCST: Completed Categories (Cc)
WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. In completed categoriies, number of categories completed out of 6 sorting categories after the test was evaluated. Ranges from 0 to 6. The more the number of categories completed the better is the response.
Measured: Baseline and End of Week 12
WCST: Correct Responses (Rc)
WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. The number of correct responses which meets all the requirements according to the response principles was evaluated. Ranges from 0-116, the more the better.
Measured: Baseline and End of Week 12
WCST: Error Responses (Re)
WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Number of error responses which did not comply with the response principles was evaluated. Ranges from 0 to 128, the less the better.
Measured: Baseline and End of Week 12
WCST: Percentage of Correct Responses (Rc%)
WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Percentage of correct responses which meets all the requirements according to the response principles was evaluated. Ranges from 0 to 100 percent (%), the more the better.
Measured: Baseline and End of Week 12
WCST: First Response (Rf)
WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Number of responses needed to complete the first color classification was evaluated. Ranges from 9 to 128, the lesser the better.
Measured: Baseline and End of Week 12
WCST: Percentage of Conceptual Level Responses (Rf%)
WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Percentage of the responses completed with 3-10 continuous correct during the entire measuring process was evaluated. Ranges from 0 to 100%, the more the better.
Measured: Baseline and End of Week 12
WCST: Perseverative Responses (Rp)
WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Number of perseverative responses were the responses which applied continuity principle for matching answers was evaluated. Ranges from 0 to 100, the less the better.
Measured: Baseline and End of Week 12
WCST: Perseverative Error Responses (Rpe)
WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Perseverative error responses are the number of responses which applied continuity principle for matching answers and also had the wrong answer was evaluated. Ranges from 0 to 128, the less the better.
Measured: Baseline and End of Week 12
WCST: Percentage of Perseverative Error Responses (Rpe%)
WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative (pvt) errors; nonperseverative errors; failure to maintain set; learning to learn. Percentage of persistent errors out of total number of responses was evaluated. Ranges from 0 to 100%, the less the better.
Measured: Baseline and End of Week 12
WCST: Non-Persistent Error Responses (nRpe)
WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Non perseverative error responses are the errors remaining after subtracting persistent errors from total errors. Ranges from 0 to 128 and was not linear (cannot be considered to be good or bad just judged by the number, analyzed with other factors case by case).
Measured: Baseline and End of Week 12
WCST: Failure to Maintain Set (Fm)
WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. The frequency (number of times) of responses completed with 5 to 9 continuous correct was evaluated. Ranges from 0 to 26 and was not linear (cannot be considered to be good or bad just judged by the number, analyzed with other factors case by case).
Measured: Baseline and End of Week 12
WCST: Learning to Learn (L-C)
WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. "Learning to learn" indicator was a measure of decrement in the number of responses needed to achieve each successive category. The raw score ranged from 0 to 100. The high, negative value suggests the participants could not effectively learn the task presented by the WCST. Only calculated in those completed 3 or more categories and not linear (cannot be considered to be good or bad just judged by the number, analyzed with other factors case by case).
Measured: Baseline and End of Week 12
Coding Test
The coding Test is a common test indicator for perceptual speed. The test presents a series of corresponding relationship between graphics and symbols to the participant, and then participants will be required to fill out the appropriate symbol following single symbol in the test part. The test is limited within 150 seconds and evaluated the number of symbols been replaced correctly by the participants.
Measured: Baseline and End of Week 12
Academic Achievement
Mathematics and language scores will be obtained from their corresponding examinations at school. Scores ranges from 0-100 respectively. Mathematics and language would be summarized separately.
Measured: Baseline and End of Week 12
Number of Participants With Clinical Global Impression - CGI Scale Score
CGI is an overall rating scale. Clinical Global Impression (Improvement of Diseases) is divided into seven grades: 1=very significant improvement, 24=significant improvement or advanced, 3=improvement or slightly advanced, 4=no change, 5=slight aggravation, 6=significant aggravation, and 7=very significant aggravation or seriously aggravated. Number of participants in each category of grade were assessed.
Measured: End of Week 1, 2, 3, 7 and 12
Change From Baseline in I/O Score of IOWA Conners Behavior Rating Scale at Week 12
IOWA conners behavior rating scale score in different dosage groups will be accessed to evaluate relationship between therapeutic effect and dosage. IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.
Measured: Baseline and End of Week 12
Change From Baseline in Total Scores of Digit Span Test at Week 12
The digit span test total score will be accessed in different dosage groups to evaluate the relationship between therapeutic effect and dosage. The digit span test is mainly used to measure the ability of short-term memory and attention. The participant will be given a string of digits and asked to repeat them forward, and then a second string of digits to repeat backward. The score is the number of correct responses, where the digits were repeated correctly. One point will be given for each correctly repeated string of digits. The maximum subscore in the Digits Forward is16, and the maximum subscore in the Digits Backward is 14, for a total score of 30. A higher score was indicative of better recall and attention.
Measured: Baseline and End of Week 12
Change From Baseline in Completion Time of Stroop Color-word Test at Week 12
Completion time of stroop color-word test in different dosage groups will be accessed to evaluate the relationship between therapeutic effect and dosage. This is a psychological test to observe the interference in which disparity between the meaning and color affects reading speed. A participant will be given 3 tasks of recognition: reading the printed colored ink (Color Test), reading color words in black ink (Word Test), and interference, reading color words printed in different colored ink (Word-Color Test). The test will be scored on the number of correct answers. There are 100 items for each of the three categories and if they made it through the 100 words with time remaining, they would repeat the list. Median time of the naming time in the Stroop color word naming test will be accessed. Stroop color word naming test 1 ,2 ,3 and 4 stand for gradually increased difficulty and each test has a corresponding baseline and endpoint.
Measured: Baseline and End of Week 12
Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale at Week 12
Remission rate in different dosage groups will be accessed to evaluate the relationship between therapeutic effect and dosage. Remission rate is the percentage of participants with total score of IO sub-scale less than or equal to 5 in IOWA Conners measurement scale.
Measured: Week 12
Number of Participants Compliant With Treatment
Number of Participants who are Compliant with Treatment will be accessed. Less than 80 percent and more than 120 percent compliance signifies bad compliance, 80 to 120 percent compliance signifies good compliance . The compliance was calculated by the percentage of dose (actual dose multiplied by 100/theoretical dose).The theoretical dose means the dose prescribed by the Investigator.
Measured: End of Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startDec 2009
- Primary completionNov 2010
- Study completionNov 2010
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 (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies 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
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xian-Janssen Pharmaceutical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutica Clinical trial, Study director, Janssen Pharmaceutica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933880
- Sponsor's protocol ID
- CR016078
- Other IDs
- CONCERTAATT4099
- Status last verified
- Sep 2014
- First submitted
- 28 Aug 2013
- Last updated
- 17 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Zheng Y, Liang JM, Gao HY, Yang ZW, Jia FJ, Liang YZ, Fang F, Li R, Xie SN, Zhuo JM. An Open-label, Self-control, Prospective Study on Cognitive Function, Academic Performance, and Tolerability of Osmotic-release Oral System Methylphenidate in Children with Attention-deficit Hyperactivity Disorder. Chin Med J (Engl). 2015 Nov 20;128(22):2988-97. doi: 10.4103/0366-6999.168948.
PubMed 26608976
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Self-Controlled, Prospective Study of Concerta on Cognitive Functions, Efficacy and Tolerance in the Pediatric Patients With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT01933880
- Acronym / sponsor ID
- CR016078
- Keywords
- Attention Deficit Hyperactivity Disorder, Methylphenidate Hydrochloride, CONCERTA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Xian-Janssen Pharmaceutical Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 2 Sep 2013 (estimated)
- Results
- Posted 17 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this long term post-marketing study is to evaluate the effectiveness and safety of osmotic release oral system methylphenidate hydrochloride (OROS-MPH) in participants with Attention Deficit Hyperactivity Disorder (ADHD).
Detailed description
This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), self-controlled, long-term post-marketing study in participants with ADHD. The study consists of 3 periods: screening period, wash-out period/run-in period (3 days), and open-label treatment period (12 weeks) which is divided into 2 periods that is dosage adjustment period and dose-optimization period. The total duration of the study is 12 weeks. During the dosage adjustment period, the dose of methylphenidate hydrochloride was adjusted to the optimal dose within 1-3 weeks starting with initial dosage of 18 milligram per day (mg/d) which can be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance. Participants will receive the optimal dose determined during dose adjustment period for 9 weeks during the dose-optimization period. In the study, 2 types of participants will be enrolled in 2 groups (according to condition): OROS-MPH group (participants with ADHD) and the normal children group (healthy participants). The efficacy will be assessed primarily by Digit Span Test and Inattention /Over activity With Aggression (IOWA) Conners evaluation scale. Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OROS-MPH Group | Experimental | Drug: Osmotic Release Oral System Methylphenidate Hydrochloride (OROS-MPH)Participants with ADHD will receive OROS -MPH starting at initial dosage of 18 milligram per day (mg/d) which can be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance. |
| Normal Group | Active comparator | Other: No interventionParticipants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- ADHD children must sign the consent form in person, and their parents or guardian must endorse, in the consent form, participation of the child in the designated research program
- Through personal interaction and assessment questionnaire, examine to determine compliance of DSM-IV ADHD diagnostic criteria
- According to the judgment of researchers, the ADHD children should have normal intelligence. Normal intelligence is defined as no obvious evidence of mental retardation in general (specific learning disabilities will not be considered mental retardation in general), formal IQ test to be conducted and 85 marks or above ought to be scored
- ADHD children should not have been subjected to psychotropic drug treatment within 6 months. Those ADHD children on whom methylphenidate immediate-release tablets treatment is effective (with maximum daily dosage of 60 mg), may be admitted
- Normal children with IQ greater than or equal to 85
Key exclusion criteria (5 listed)
- Unable to fully comply with the cognitive function test in the laboratory
- Known to be allergic to methylphenidate
- Consumption of psychoactive drugs currently or in the past 30 days, including use of monoamine oxidase inhibitors, clonidine, other alpha 2 adrenergic receptor agonists, tricyclic antidepressants, theophylline, bishydroxycoumarin etc
- History of alcohol, drugs or substances abuse
- Have medical history of type I or II bipolar affective disorder, anxiety disorder, schizophrenia or pervasive developmental disorder
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 |
|---|---|---|
| Osmotic Release Oral System Methylphenidate Hydrochloride (OROS-MPH)Osmotic release oral system methylphenidate hydrochloride (OROS-MPH) starting at initial dosage of 18 milligram per day (mg/d) which can be increased to 36mg/d up to a maximum dosage of 54mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18mg due to intolerance. | Drug | OROS-MPH Group |
| No interventionParticipants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children. | Other | Normal Group |
Primary outcome
Change From Baseline in Digit Span Test Total Score at Week 12
Time frame: Baseline and Week 12
The digit span test is mainly used to measure the ability of short-term memory and attention. The participant will be given a string of digits and asked to repeat them forward, and then a second string of digits to repeat backward. The score is the number of correct responses, where the digits were repeated correctly. One point will be given for each correctly repeated string of digits. The maximum subscore in the Digits Forward is 16, and the maximum subscore in the Digits Backward is 14, summed for a total score of 30. A higher score is indicative of better recall and attention.
Change From Baseline in Inattention/Overactivity With Aggression (IOWA) Conners Behavior Rating Scale - I/O Score at Week 1
Time frame: Baseline and Week 1
IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.
Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 2
Time frame: Baseline and Week 2
IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.
Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 3
Time frame: Baseline and Week 3
IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.
Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 7
Time frame: Baseline and Week 7
IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.
Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 12
Time frame: Baseline and Week 12
IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.
23 secondary outcomes
Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale.
Time frame: End of Week 1, 2, 3, 7 and 12
Stroop Color Word Naming Test
Time frame: Baseline and End of Week 12
Wisconsin Card Sorting Test (WCST): Administered Responses (Ra) of Completed Examination
Time frame: Baseline and End of Week 12
WCST: Completed Categories (Cc)
Time frame: Baseline and End of Week 12
WCST: Correct Responses (Rc)
Time frame: Baseline and End of Week 12
WCST: Error Responses (Re)
Time frame: Baseline and End of Week 12
WCST: Percentage of Correct Responses (Rc%)
Time frame: Baseline and End of Week 12
WCST: First Response (Rf)
Time frame: Baseline and End of Week 12
WCST: Percentage of Conceptual Level Responses (Rf%)
Time frame: Baseline and End of Week 12
WCST: Perseverative Responses (Rp)
Time frame: Baseline and End of Week 12
WCST: Perseverative Error Responses (Rpe)
Time frame: Baseline and End of Week 12
WCST: Percentage of Perseverative Error Responses (Rpe%)
Time frame: Baseline and End of Week 12
WCST: Non-Persistent Error Responses (nRpe)
Time frame: Baseline and End of Week 12
WCST: Failure to Maintain Set (Fm)
Time frame: Baseline and End of Week 12
WCST: Learning to Learn (L-C)
Time frame: Baseline and End of Week 12
Coding Test
Time frame: Baseline and End of Week 12
Academic Achievement
Time frame: Baseline and End of Week 12
Number of Participants With Clinical Global Impression - CGI Scale Score
Time frame: End of Week 1, 2, 3, 7 and 12
Change From Baseline in I/O Score of IOWA Conners Behavior Rating Scale at Week 12
Time frame: Baseline and End of Week 12
Change From Baseline in Total Scores of Digit Span Test at Week 12
Time frame: Baseline and End of Week 12
Change From Baseline in Completion Time of Stroop Color-word Test at Week 12
Time frame: Baseline and End of Week 12
Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale at Week 12
Time frame: Week 12
Number of Participants Compliant With Treatment
Time frame: End of Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26608976Zheng Y, Liang JM, Gao HY, Yang ZW, Jia FJ, Liang YZ, Fang F, Li R, Xie SN, Zhuo JM. An Open-label, Self-control, Prospective Study on Cognitive Function, Academic Performance, and Tolerability of Osmotic-release Oral System Methylphenidate in Children with Attention-deficit Hyperactivity Disorder. Chin Med J (Engl). 2015 Nov 20;128(22):2988-97. doi: 10.4103/0366-6999.168948.
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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.
Janssen Pharmaceutica Clinical trial study director
Janssen Pharmaceutica
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Osmotic Release Oral System Methylphenidate Hydrochloride (OROS-MPH) in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Xian-Janssen Pharmaceutical Ltd. at 6 sites in China.
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 5 inclusion and 5 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 17 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. 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?
Yes. Results are posted in the registry (first posted 17 Sep 2014). 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?
Change From Baseline in Digit Span Test Total Score at Week 12 (time frame: Baseline and Week 12). The study lists 6 primary outcomes in all. 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 NCT01933880, 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 17 Sep 2014.