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

NCT ID: NCT01933880

Last Updated: 2014-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2010-11-30

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.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OROS-MPH Group

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.

Group Type: EXPERIMENTAL

Osmotic Release Oral System Methylphenidate Hydrochloride (OROS-MPH)

Intervention Type: 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.

Normal Group

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.

Group Type: ACTIVE_COMPARATOR

No intervention

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DRUG

No intervention

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xian-Janssen Pharmaceutical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutica Clinical trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutica

Locations

Beijing, , China

Changchun, , China

Guangzhou, , China

Hangzhou, , China

Shanghai, , China

Shenzhen, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 26608976 (View on PubMed)

Other Identifiers

CONCERTAATT4099

Identifier Type: -

Identifier Source: secondary_id

CR016078

Identifier Type: -

Identifier Source: org_study_id