NCT01624649

Brief Summary

The purpose of this observational study is to explore the efficacy of methylphenidate hydrochloride in children and adolescents diagnosed with attention-deficit hyperactivity disorder (ADHD) by Kiddie-scheduled for affective disorders (SADS)-present and life time version (K-SADS-PL).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
289

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Typical duration for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

June 9, 2015

Status Verified

June 1, 2015

Enrollment Period

2.2 years

First QC Date

June 19, 2012

Last Update Submit

June 8, 2015

Conditions

Attention-deficit Hyperactivity Disorder

Keywords

Attention-deficit hyperactivity disorderDevelopmental disorderAtomoxetineMethylphenidatePsychiatric disorder

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the ADHD Rating Scale (ARS)

    The ADHD Rating Scale (ARS) - Parent Version: ARS contains 18 items, in which parent version of the questionnaire is based on home behaviors.

    Baseline and Week 52

Secondary Outcomes (6)

  • Clinical Global Impression-Severity (CGI-S)

    Baseline to Week 52

  • Adherence Rate

    Week 4 to Week 52

  • Comprehensive Attention Test (CAT)

    Baseline, Week 24 and Week 52

  • Academic Performance Rating Scale (APRS)

    Baseline, Week 24 and Week 52

  • Symptoms Checklist (SCL-90) for Parent Depression

    Baseline, Week 24 and Week 52

  • +1 more secondary outcomes

Study Arms (1)

Patients with ADHD

Patients will receive methylphenidate hydrochloride or atomoxetine. The methylphenidate hydrochloride is available in three forms. 1) Immediate release 2) Extended release 3) Osmotic release oral system

Drug: Methylphenidate hydrochlorideDrug: Atomoxetine

Interventions

Methylphenidate hydrochlorideDRUG

Form = tablet, route = oral, administered as a flexible dosage

Patients with ADHD
AtomoxetineDRUG

Form = tablet, route = oral;

Patients with ADHD

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children and adolescents of age between 6 and 15 years (in Korean age) who are dianosed with ADHD by K-SADS-PL but have never received any of methylphenidate or atomoxetine within 3 months prior to screening.

You may qualify if:

  • Has been diagnosed with attention-deficit hyperactivity disorder (ADHD) by Kiddie-SADS-present and life time version (K-SADS-PL)
  • Have not received methylphenidate or atomoxetine within 3 months prior to screening.

You may not qualify if:

  • Has intelligence quotient (IQ) ≤70 assessed by comprehensive attention test (CAT) at screening diagnosed with congenital disorders
  • Has had history of acquired brain damage (eg, cerebral palsy)
  • Has had diagnosed with convulsive disabilities or other neurological disease or dysesthesia
  • Has had developmental disabilities such as autistic spectrum disorder
  • Has had history of schizophrenia, bipolar, or other pediatric psychotic disorder, and obsessive compulsive disorder
  • Has had linguistic disability and had diagnosed with tic disorder that requires additional drug treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Bucheon-Si Gyeonggi-Do, South Korea

Location

Unknown Facility

Daegu, South Korea

Location

Unknown Facility

Gyeongsangnam-Do, South Korea

Location

Unknown Facility

Jeju Special Self-Governing Province, South Korea

Location

Unknown Facility

Jeonju, South Korea

Location

Unknown Facility

Kyunggi-Do, South Korea

Location

Unknown Facility

Seongnam, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Suwon, South Korea

Location

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityDevelopmental DisabilitiesMental Disorders

Interventions

MethylphenidateAtomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPropylaminesAmines

Study Officials

  • Janssen Korea, Ltd., Korea Clinical Trial

    Janssen Korea, Ltd., Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2012

First Posted

June 21, 2012

Study Start

February 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

June 9, 2015

Record last verified: 2015-06

Locations

KR(9)