A Study to Examine the Progression of Attention-Deficit Hyperactivity Disorder (ADHD) Drug Treatment and to Analyze Associated Factors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

289 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of the Effectiveness and Safety of Prolonged-release Methylphenidate Hydrochloride in Adult Patients With Attention Deficit/Hyperactivity Disorder.

NCT00246220

Attention Deficit Disorder With Hyperactivity

COMPLETED PHASE3

Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD)

NCT01259492

Attention Deficit/Hyperactivity Disorder

COMPLETED PHASE3

The Effect of Methylphenidate Treatment in Familial Attention Deficit/Hyperactivity Disorder (ADHD)

NCT01554046

Attention Deficit/Hyperactivity Disorder Combined Type ADHD Predominantly Inattentive Type ADHD Predominantly Hyperactivity Type +1 more

COMPLETED NA

Stimulant Drug Treatment of Attention-Deficit Hyperactivity Disorder (AD/HD), Inattentive Type

NCT00824317

ADHD

COMPLETED NA

Identification of Neuropsychological, Genetic and Neuroimaging Markers and Treatment Response Predictors of ADHD

NCT02430896

Attention Deficit Disorder With Hyperactivity

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a 1-year open-label (all people involved know the identity of the assigned drug), multicenter, single arm, prospective, observational study to explore under natural setting the efficacy of drug treatment in children and adolescents diagnosed with ADHD by K-SADS-PL (K-SADS-PL is a tool used for ADHD diagnosis. Patient may be diagnosed with ADHD by using K-SADS-PL to check if he or she meets the criteria according to Diagnostic and Statistical Manual of Mental Disorders \& edition (DSM-IV). After obtaining informed consent, investigator will prescribe stimulant or non-stimulant ADHD treatment medications (ie, Immediate release \[IR\]/extended release \[ER\]/osmotic release oral system (OROS) methylphenidate, atomoxetine). Efficacy and safety assessments will be performed at 4, 12, 24, 36, and 52 weeks after the first day of giving study drug. Progression of symptom improvement and adherence will be investigated and associated variables (ie, demographic, clinical, familial and treatment factors) will be analyzed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Attention-deficit Hyperactivity Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Methylphenidate hydrochloride

Intervention Type DRUG

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

Atomoxetine

Intervention Type DRUG

Form = tablet, route = oral;

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Methylphenidate hydrochloride

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

Intervention Type DRUG

Atomoxetine

Form = tablet, route = oral;

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No