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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Attention-deficit Hyperactivity Disorder

Treatments: Drug: Methylphenidate hydrochloride; Drug: Atomoxetine

Study type: Observational

Funder types: Industry

Identifiers

NCT01624649

CONCERTAATT4107 (Other Identifier)

CON-KOR-5026 (Other Identifier)

CR100744

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 289 patients

Sex: All

Ages: 6 to 15 years old

Volunteers: No Healthy Volunteers

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.

Trial design

289 participants in 1 patient group

Patients with ADHD

Description:

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

Treatment:

Drug: Methylphenidate hydrochloride

Drug: Atomoxetine