Phase 4 Completed N=142 Treatment

An Efficacy and Safety Study of Osmotic Release Oral System (OROS) Methylphenidate in Participants With Attention Deficit Hyperactivity Disorder (ADHD)

Attention Deficit Disorder With Hyperactivity

Source: ClinicalTrials.gov NCT01012622 ↗

Enrolled (actual)

142

Serious AEs

0.0%

Results posted

Feb 2014

Primary outcomePrimary: Change From Baseline in Korean Version of the Attention-Deficit Hyperactivity Disorder (K-ADHD) Rating Scale (K-ARS) Total Score at Week 12 — 33.37; -20.43 units on a scale

Summary

The purpose of this study is to evaluate the safety and efficacy of Osmotic Release Oral System (OROS) methylphenidate in participants with Attention Deficit Hyperactivity Disorder (ADHD).

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Korean Version of the Attention-Deficit Hyperactivity Disorder (K-ADHD) Rating Scale (K-ARS) Total Score at Week 12	33.37; -20.43	—
PRIMARY Number of Participants With Response Based on K-ARS Total Score at Week 12	118	—
PRIMARY Number of Participants With Remission Based on K-ARS Total Score and Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 12	99	—
SECONDARY Change From Baseline in Child Health and Illness Profile-Child Edition (CHIP) Total Score and 5 Sub-domains Score at Week 12	207.85; 18.08; 26.17; 2.27; 82.13; 4.47	—
SECONDARY Change From Baseline in Visual Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12	8.79; -4.53; 17.42; -5.03; 501.32; -37.41	—
SECONDARY Change From Baseline in Auditory Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12	10.31; -6.27; 12.07; -3.61; 623.95; -55.34	—
SECONDARY Change From Baseline in Inhibition-Sustained Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12	35.78; -20.39; 27.73; -7.54; 576.55; -34.44	—
SECONDARY Change From Baseline in Interference-Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12	20.39; -10.83; 26.03; -6.14; 648.48; -54.35	—
SECONDARY Change From Baseline in Divided Attention Subtest of Comprehensive Attention Test (CAT) at Week 12	16.05; -4.07; 16.03; -4.73; 749.01; -27.14	—
SECONDARY Change From Baseline in Working Memory Forward Subtest of Comprehensive Attention Test (CAT) at Week 12	5.76; 0.63; 4.46; 0.25	—
SECONDARY Change From Baseline in Working Memory Backward Subtest of Comprehensive Attention Test (CAT) at Week 12	4.22; 1.86; 3.63; 1.24	—
SECONDARY Change From Baseline in Academic Performance Rating Scale (APRS) Score at Week 12	55.46; 7.40	—
SECONDARY Change From Baseline in Beck Depression Inventory (BDI) Score at Week 12	11.69; -1.89	—
SECONDARY Change From Baseline in Parenting Stress Index (PSI) Total Score at Week 12	58.20; -5.25	—
SECONDARY Change From Baseline in Clinical Global Impression-severity (CGI-S) Score at Week 12	5.14; -2.51	—
SECONDARY Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 12	122; 7	—

Eligibility Criteria

Inclusion Criteria

Participants voluntarily provided informed consent to participate in the study
Participants with written informed consent to participate in the study voluntarily by caregivers/legal representatives
Participants who were capable to follow the study visit schedule well and their parents/caregivers who were willing to complete the assessments specified in the protocol and were capable to complete them
Participant and his/her parent/guardian able to understand the study participation and to request withdrawal from the study voluntarily at any time
Participants who were satisfied in diagnosis of Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) Attention Deficit Hyperactivity Disorder (ADHD) and determined to require drug therapy

Exclusion Criteria

Participants who have known hypersensitivity (altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen) to methylphenidate HCL
Participants who have significant suicidal ideation
Participants with mental retardation
Participants who meet DSM-IV diagnostic criteria for current major depressive disorder or anxiety disorder requiring drug therapy
Participants who have abnormalities in the Electrocardiography (ECG) or show clinically significant abnormalities of laboratory results, including serum chemistries and hematology

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01012622). 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.