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

Attention-deficit Hyperactivity Disorder Clinical Trial

Official title:

Prospective Follow-Up Observational Study to Examine the Progression of ADHD Drug Treatment and to Analyze Associated Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01624649
• Other study ID #: CR100744
• Secondary ID: CONCERTAATT4107C
• Status: Completed
• Phase: Phase 4
• First received: June 19, 2012
• Last updated: June 8, 2015
• Start date: February 2012
• Est. completion date: April 2014

Study information

• Verified date: June 2015
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Korea Food and Drug Administration (KFDA)Republic of Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 15 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Methylphenidate hydrochloride
Form = tablet, route = oral, administered as a flexible dosage
• Atomoxetine
Form = tablet, route = oral;

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Clinical Global Impression-Severity (CGI-S)	CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Ratings are 1 = normal/not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = extremely ill.	Baseline to Week 52	No
Secondary	Adherence Rate	Pill count at each visit; at least 50% adherence rate will be considered clinically relevant.	Week 4 to Week 52	No
Secondary	Comprehensive Attention Test (CAT)	CAT is a computerized test which includes attention task, sustained attention to response, flanker task, divided attention task, and spatial working memory task.	Baseline, Week 24 and Week 52	No
Secondary	Academic Performance Rating Scale (APRS)	APRS is a 19-item scale, where parents rate the child's academic abilities and behaviors on a 5-point scale. Higher scores indicate greater academic performance.	Baseline, Week 24 and Week 52	No
Secondary	Symptoms Checklist (SCL-90) for Parent Depression		Baseline, Week 24 and Week 52	No
Secondary	Clinical Global Impression- Improvement (CGI-I)	CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. It is rated as 1, every much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.	Baseline and Week 52	No