Phase 4
Completed N=194
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
Source: ClinicalTrials.gov NCT01933880 ↗Enrolled (actual)
194
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Change From Baseline in Digit Span Test Total Score at Week 12 — 11.7; 13.7; 1; 0.5 Scores on a scale — p=0.0387
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Digit Span Test Total Score at Week 12 |
11.7; 13.7; 1; 0.5 | 0.0387 sig |
| PRIMARY Change From Baseline in Inattention/Overactivity With Aggression (IOWA) Conners Behavior Rating Scale - I/O Score at Week 1 |
10; -2.7 | <0.0001 sig |
| PRIMARY Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 2 |
10; -4.1 | 0.0001 sig |
| PRIMARY Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 3 |
10; -5 | <0.0001 sig |
| PRIMARY Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 7 |
10; -5.8 | <0.0001 sig |
| PRIMARY Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 12 |
10; -6.2 | <0.0001 sig |
| SECONDARY Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale. |
25.98; 51.97; 66.93; 78.74; 81.10 | — |
| SECONDARY Stroop Color Word Naming Test |
20.561; 6.213; 18.961; 5.7; 19.32; 7.15 | — |
| SECONDARY Wisconsin Card Sorting Test (WCST): Administered Responses (Ra) of Completed Examination |
125.1; 120.8; 116.4; 117.1 | — |
| SECONDARY WCST: Completed Categories (Cc) |
3.2; 3.3; 4.1; 4 | — |
| SECONDARY WCST: Correct Responses (Rc) |
72.9; 77.9; 80.3; 84.7 | — |
| SECONDARY WCST: Error Responses (Re) |
52.3; 42.9; 36.1; 32.3 | — |
| SECONDARY WCST: Percentage of Correct Responses (Rc%) |
58.678; 65.52; 70.096; 73.34 | — |
| SECONDARY WCST: First Response (Rf) |
22.6; 25.2; 23.4; 26.5 | — |
| SECONDARY WCST: Percentage of Conceptual Level Responses (Rf%) |
46.36; 54.73; 61.07; 65 | — |
| SECONDARY WCST: Perseverative Responses (Rp) |
33.7; 26.5; 22; 18.6 | — |
| SECONDARY WCST: Perseverative Error Responses (Rpe) |
28.7; 23; 19.4; 16.4 | — |
| SECONDARY WCST: Percentage of Perseverative Error Responses (Rpe%) |
22.67; 18.45; 16.07; 13.59 | — |
| SECONDARY WCST: Non-Persistent Error Responses (nRpe) |
23.54; 19.98; 16.75; 15.8 | — |
| SECONDARY WCST: Failure to Maintain Set (Fm) |
1.7; 2.3; 2; 2.5 | — |
| SECONDARY WCST: Learning to Learn (L-C) |
-2.49; -2.37; -1.87; -1.34 | — |
| SECONDARY Coding Test |
63.4; 77.4; 73.2; 83.1 | — |
| SECONDARY Academic Achievement |
77.35; 94.21; 83.94; 94.56; 78.86; 96.23 | — |
| SECONDARY Number of Participants With Clinical Global Impression - CGI Scale Score |
20; 28; 29; 35; 36; 59 | — |
| SECONDARY Change From Baseline in I/O Score of IOWA Conners Behavior Rating Scale at Week 12 |
10; 10.3; 7; -6.8; -5.8; -4 | — |
| SECONDARY Change From Baseline in Total Scores of Digit Span Test at Week 12 |
11.7; 11.3; 15; 1.2; 0.8; 0 | — |
| SECONDARY Change From Baseline in Completion Time of Stroop Color-word Test at Week 12 |
22.229; 17.7; 5; -3.318; -1; 0 | — |
| SECONDARY Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale at Week 12 |
85.37; 74.07; 100.00 | — |
| SECONDARY Number of Participants Compliant With Treatment |
17; 110; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01933880). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.