Clinical trial NCT01933880: 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
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: Attention Deficit Hyperactivity Disorder
Methylphenidate Hydrochloride
CONCERTA
Lead sponsor: Xian-Janssen Pharmaceutical Ltd.
Sponsor class: INDUSTRY
First posted: 2013-09-02
Enrollment: 194
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

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

Primary outcomes:
measure: Change From Baseline in Digit Span Test Total Score at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Inattention/Overactivity With Aggression (IOWA) Conners Behavior Rating Scale - I/O Score at Week 1
timeFrame: Baseline and Week 1
measure: Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 2
timeFrame: Baseline and Week 2
measure: Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 3
timeFrame: Baseline and Week 3
measure: Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 7
timeFrame: Baseline and Week 7
measure: Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale.
timeFrame: End of Week 1, 2, 3, 7 and 12
measure: Stroop Color Word Naming Test
timeFrame: Baseline and End of Week 12
measure: Wisconsin Card Sorting Test (WCST): Administered Responses (Ra) of Completed Examination
timeFrame: Baseline and End of Week 12
measure: WCST: Completed Categories (Cc)
timeFrame: Baseline and End of Week 12
measure: WCST: Correct Responses (Rc)
timeFrame: Baseline and End of Week 12
measure: WCST: Error Responses (Re)
timeFrame: Baseline and End of Week 12
measure: WCST: Percentage of Correct Responses (Rc%)
timeFrame: Baseline and End of Week 12
measure: WCST: First Response (Rf)
timeFrame: Baseline and End of Week 12
measure: WCST: Percentage of Conceptual Level Responses (Rf%)
timeFrame: Baseline and End of Week 12
measure: WCST: Perseverative Responses (Rp)
timeFrame: Baseline and End of Week 12
measure: WCST: Perseverative Error Responses (Rpe)
timeFrame: Baseline and End of Week 12
measure: WCST: Percentage of Perseverative Error Responses (Rpe%)
timeFrame: Baseline and End of Week 12
measure: WCST: Non-Persistent Error Responses (nRpe)
timeFrame: Baseline and End of Week 12
measure: WCST: Failure to Maintain Set (Fm)
timeFrame: Baseline and End of Week 12
measure: WCST: Learning to Learn (L-C)
timeFrame: Baseline and End of Week 12
measure: Coding Test
timeFrame: Baseline and End of Week 12
measure: Academic Achievement
timeFrame: Baseline and End of Week 12
measure: Number of Participants With Clinical Global Impression - CGI Scale Score
timeFrame: End of Week 1, 2, 3, 7 and 12
measure: Change From Baseline in I/O Score of IOWA Conners Behavior Rating Scale at Week 12
timeFrame: Baseline and End of Week 12
measure: Change From Baseline in Total Scores of Digit Span Test at Week 12
timeFrame: Baseline and End of Week 12
measure: Change From Baseline in Completion Time of Stroop Color-word Test at Week 12
timeFrame: Baseline and End of Week 12
measure: Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale at Week 12
timeFrame: Week 12
measure: Number of Participants Compliant With Treatment
timeFrame: End of Week 12
Other outcomes:
Locations:
city: Beijing
country: China
city: Changchun City
country: China
city: Guangzhou
country: China
city: Hangzhou
country: China
city: Shanghai
country: China
city: Shenzhen
country: China
Study officials:
affiliation: Janssen Pharmaceutica
name: Janssen Pharmaceutica Clinical trial
role: STUDY_DIRECTOR
References:
citation: 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.