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
NCT01933880, Phase 4, Completed, Xian-Janssen Pharmaceutical Ltd.; results first posted 2014-09-17
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | 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 | ClinicalTrials.gov |
| NCT number | NCT01933880 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 194 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Xian-Janssen Pharmaceutical Ltd. | ClinicalTrials.gov |
| Conditions | Attention Deficit Hyperactivity Disorder (ADHD) | ClinicalTrials.gov |
| Interventions | Osmotic Release Oral System Methylphenidate Hydrochloride (OROS-MPH), No intervention | ClinicalTrials.gov |
| First posted | 2013-09-02 | ClinicalTrials.gov |
| Last updated | 2014-09-17 | ClinicalTrials.gov |
| Results first posted | 2014-09-17 | ClinicalTrials.gov |
Registered outcomes 29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change From Baseline in Digit Span Test Total Score at Week 12 | 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. | ClinicalTrials.gov |
| Primary | Change From Baseline in Inattention/Overactivity With Aggression (IOWA) Conners Behavior Rating Scale - I/O Score at Week 1 | 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. | ClinicalTrials.gov |
| Primary | Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 2 | 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. | ClinicalTrials.gov |
| Primary | Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 3 | 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. | ClinicalTrials.gov |
| Primary | Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 7 | 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. | ClinicalTrials.gov |
| Primary | Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 12 | 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. | ClinicalTrials.gov |
| Secondary | Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale. | End of Week 1, 2, 3, 7 and 12 | 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 | ClinicalTrials.gov |
| Secondary | Stroop Color Word Naming Test | Baseline and End of Week 12 | 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. | ClinicalTrials.gov |
| Secondary | Wisconsin Card Sorting Test (WCST): Administered Responses (Ra) of Completed Examination | Baseline and End of Week 12 | 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. | ClinicalTrials.gov |
| Secondary | WCST: Completed Categories (Cc) | Baseline and End of Week 12 | 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. | ClinicalTrials.gov |
| Secondary | WCST: Correct Responses (Rc) | Baseline and End of Week 12 | 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. | ClinicalTrials.gov |
| Secondary | WCST: Error Responses (Re) | Baseline and End of Week 12 | 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. | ClinicalTrials.gov |
| Secondary | WCST: Percentage of Correct Responses (Rc%) | Baseline and End of Week 12 | 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. | ClinicalTrials.gov |
| Secondary | WCST: First Response (Rf) | Baseline and End of Week 12 | 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. | ClinicalTrials.gov |
| Secondary | WCST: Percentage of Conceptual Level Responses (Rf%) | Baseline and End of Week 12 | 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. | ClinicalTrials.gov |
| Secondary | WCST: Perseverative Responses (Rp) | Baseline and End of Week 12 | 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. | ClinicalTrials.gov |
| Secondary | WCST: Perseverative Error Responses (Rpe) | Baseline and End of Week 12 | 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. | ClinicalTrials.gov |
| Secondary | WCST: Percentage of Perseverative Error Responses (Rpe%) | Baseline and End of Week 12 | 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. | ClinicalTrials.gov |
| Secondary | WCST: Non-Persistent Error Responses (nRpe) | Baseline and End of Week 12 | 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). | ClinicalTrials.gov |
| Secondary | WCST: Failure to Maintain Set (Fm) | Baseline and End of Week 12 | 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). | ClinicalTrials.gov |
Outcomes 29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Digit Span Test Total Score at Week 12 | Baseline and Week 12 | Full Analysis Set (FAS) population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. FAS for normal group included all participants who received baseline assessment scale evaluation and had at least one endpoint assessment scale evaluation. | Scores on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline in Inattention/Overactivity With Aggression (IOWA) Conners Behavior Rating Scale - I/O Score at Week 1 | Baseline and Week 1 | FAS population for OROS-MPH Group. Here N signifies number of participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test. | Scores on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 2 | Baseline and Week 2 | FAS population for OROS-MPH Group. Here N signifies number of participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test. | Scores on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 3 | Baseline and Week 3 | FAS population for OROS-MPH Group. Here N signifies number of participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test. | Scores on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 7 | Baseline and Week 7 | FAS population for OROS-MPH Group. Here N signifies number of participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test. | Scores on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 12 | Baseline and Week 12 | FAS population for OROS-MPH Group. Here N signifies number of participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test. | Scores on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale. | End of Week 1, 2, 3, 7 and 12 | FAS population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test. | Percentage of Participants | NUMBER | ClinicalTrials.gov |
| SECONDARY | Stroop Color Word Naming Test | Baseline and End of Week 12 | FAS for OROS-MPH Group included participants who took at least 1 study drug therapy and had at least 1 efficacy evaluation. FAS for normal group included participants who had baseline assessment scale evaluation and had at least 1 endpoint assessment scale evaluation. 'n'=participants who were evaluable at each specific time point for each arm. | Seconds | MEAN | ClinicalTrials.gov |
| SECONDARY | Wisconsin Card Sorting Test (WCST): Administered Responses (Ra) of Completed Examination | Baseline and End of Week 12 | FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm. | Responses | MEAN | ClinicalTrials.gov |
| SECONDARY | WCST: Completed Categories (Cc) | Baseline and End of Week 12 | FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm. | Nunber of Categories Completed | MEAN | ClinicalTrials.gov |
| SECONDARY | WCST: Correct Responses (Rc) | Baseline and End of Week 12 | FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm. | number of correct responses | MEAN | ClinicalTrials.gov |
| SECONDARY | WCST: Error Responses (Re) | Baseline and End of Week 12 | FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm. | number of error responses | MEAN | ClinicalTrials.gov |
| SECONDARY | WCST: Percentage of Correct Responses (Rc%) | Baseline and End of Week 12 | FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm. | Percentage of correct responses | MEAN | ClinicalTrials.gov |
| SECONDARY | WCST: First Response (Rf) | Baseline and End of Week 12 | FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm. | number of first responses | MEAN | ClinicalTrials.gov |
| SECONDARY | WCST: Percentage of Conceptual Level Responses (Rf%) | Baseline and End of Week 12 | FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm. | percentage of conceptual level responses | MEAN | ClinicalTrials.gov |
| SECONDARY | WCST: Perseverative Responses (Rp) | Baseline and End of Week 12 | FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm. | number of perseverative responses | MEAN | ClinicalTrials.gov |
| SECONDARY | WCST: Perseverative Error Responses (Rpe) | Baseline and End of Week 12 | FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm. | number of perseverative error responses | MEAN | ClinicalTrials.gov |
| SECONDARY | WCST: Percentage of Perseverative Error Responses (Rpe%) | Baseline and End of Week 12 | FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm. | Percentage of pvt error responses | MEAN | ClinicalTrials.gov |
| SECONDARY | WCST: Non-Persistent Error Responses (nRpe) | Baseline and End of Week 12 | FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm. | number of non-persistent error responses | MEAN | ClinicalTrials.gov |
| SECONDARY | WCST: Failure to Maintain Set (Fm) | Baseline and End of Week 12 | FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm. | number of times | MEAN | ClinicalTrials.gov |
Results by group 176
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Change From Baseline in Digit Span Test Total Score at Week 12 | OROS-MPH Group | Baseline | 11.7 | Standard Deviation 2.25 | Scores on a scale | ClinicalTrials.gov |
| Change From Baseline in Digit Span Test Total Score at Week 12 | Normal Group | Baseline | 13.7 | Standard Deviation 2.43 | Scores on a scale | ClinicalTrials.gov |
| Change From Baseline in Digit Span Test Total Score at Week 12 | OROS-MPH Group | Change at Week 12 | 1 | Standard Deviation 1.5 | Scores on a scale | ClinicalTrials.gov |
| Change From Baseline in Digit Span Test Total Score at Week 12 | Normal Group | Change at Week 12 | 0.5 | Standard Deviation 1.48 | Scores on a scale | ClinicalTrials.gov |
| Change From Baseline in Inattention/Overactivity With Aggression (IOWA) Conners Behavior Rating Scale - I/O Score at Week 1 | OROS-MPH Group | Baseline | 10 | Standard Deviation 2.4 | Scores on a scale | ClinicalTrials.gov |
| Change From Baseline in Inattention/Overactivity With Aggression (IOWA) Conners Behavior Rating Scale - I/O Score at Week 1 | OROS-MPH Group | Change at Week 1 | -2.7 | Standard Deviation 2.18 | Scores on a scale | ClinicalTrials.gov |
| Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 2 | OROS-MPH Group | Baseline | 10 | Standard Deviation 2.4 | Scores on a scale | ClinicalTrials.gov |
| Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 2 | OROS-MPH Group | Change at Week 2 | -4.1 | Standard Deviation 2.73 | Scores on a scale | ClinicalTrials.gov |
| Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 3 | OROS-MPH Group | Baseline | 10 | Standard Deviation 2.4 | Scores on a scale | ClinicalTrials.gov |
| Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 3 | OROS-MPH Group | Change at Week 3 | -5 | Standard Deviation 2.81 | Scores on a scale | ClinicalTrials.gov |
| Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 7 | OROS-MPH Group | Baseline | 10 | Standard Deviation 2.4 | Scores on a scale | ClinicalTrials.gov |
| Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 7 | OROS-MPH Group | Change at Week 7 | -5.8 | Standard Deviation 2.91 | Scores on a scale | ClinicalTrials.gov |
| Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 12 | OROS-MPH Group | Baseline | 10 | Standard Deviation 2.4 | Scores on a scale | ClinicalTrials.gov |
| Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 12 | OROS-MPH Group | Change at Week 12 | -6.2 | Standard Deviation 3.08 | Scores on a scale | ClinicalTrials.gov |
| Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale. | OROS-MPH Group | End of Week 1 | 25.98 | Percentage of Participants | ClinicalTrials.gov | |
| Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale. | OROS-MPH Group | End of Week 2 | 51.97 | Percentage of Participants | ClinicalTrials.gov | |
| Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale. | OROS-MPH Group | End of Week 3 | 66.93 | Percentage of Participants | ClinicalTrials.gov | |
| Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale. | OROS-MPH Group | End of Week 7 | 78.74 | Percentage of Participants | ClinicalTrials.gov | |
| Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale. | OROS-MPH Group | End of Week 12 | 81.10 | Percentage of Participants | ClinicalTrials.gov | |
| Stroop Color Word Naming Test | OROS-MPH Group | Test 1: Baseline (n=128, 40) | 20.561 | Standard Deviation 17.5433 | Seconds | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | OROS-MPH Group | 153 | ClinicalTrials.gov | |
| Overall Study | STARTED | Normal Group | 41 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | OROS-MPH Group | 123 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Normal Group | 40 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | OROS-MPH Group | 30 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Normal Group | 1 | ClinicalTrials.gov |
Adverse events 19
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Loss of Appetite | Metabolism and nutrition disorders | OROS-MPH Group | 19 | 149 | ClinicalTrials.gov | |
| other | Tinnitus | Ear and labyrinth disorders | OROS-MPH Group | 1 | 149 | ClinicalTrials.gov | |
| other | Tonsillitis | Infections and infestations | OROS-MPH Group | 1 | 149 | ClinicalTrials.gov | |
| other | Abnormal Heart Rate | Investigations | OROS-MPH Group | 1 | 149 | ClinicalTrials.gov | |
| other | Decreased Blood Pressure | Investigations | OROS-MPH Group | 2 | 149 | ClinicalTrials.gov | |
| other | Low sleep quality | Nervous system disorders | OROS-MPH Group | 3 | 149 | ClinicalTrials.gov | |
| other | Headache | Nervous system disorders | OROS-MPH Group | 2 | 149 | ClinicalTrials.gov | |
| other | Dizziness | Nervous system disorders | OROS-MPH Group | 2 | 149 | ClinicalTrials.gov | |
| other | Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | OROS-MPH Group | 1 | 149 | ClinicalTrials.gov | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | OROS-MPH Group | 1 | 149 | ClinicalTrials.gov | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | OROS-MPH Group | 1 | 149 | ClinicalTrials.gov | |
| other | Mouth and Pharynx Pain | Respiratory, thoracic and mediastinal disorders | OROS-MPH Group | 1 | 149 | ClinicalTrials.gov | |
| other | Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | OROS-MPH Group | 3 | 149 | ClinicalTrials.gov | |
| other | Difficulty in falling asleep | Psychiatric disorders | OROS-MPH Group | 1 | 149 | ClinicalTrials.gov | |
| other | Insomnia | Psychiatric disorders | OROS-MPH Group | 3 | 149 | ClinicalTrials.gov | |
| other | Irritability | Psychiatric disorders | OROS-MPH Group | 1 | 149 | ClinicalTrials.gov | |
| other | Fever | General disorders | OROS-MPH Group | 1 | 149 | ClinicalTrials.gov | |
| other | Nausea | Gastrointestinal disorders | OROS-MPH Group | 2 | 149 | ClinicalTrials.gov | |
| other | Difficulty in falling asleep | Nervous system disorders | OROS-MPH Group | 1 | 149 | ClinicalTrials.gov |
Adverse event totals 3
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | OROS-MPH Group | ClinicalTrials.gov | ||
| Total, other adverse events | OROS-MPH Group | 27 | 149 | ClinicalTrials.gov |
| Total, serious adverse events | OROS-MPH Group | 0 | 149 | ClinicalTrials.gov |
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 26608976 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Primary outcome | ConductCognition |
| Card Sorting Test (Berg) | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)