Effects of Atx and Oros-mph on Executiv… | Clinical Trial

Key information

Conditions

Executive Dysfunction Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

The aim of this study was to evaluate and compare the effects of Atomoxetine(ATX) and osmotic release oral system-methylphenidate (OROS-MPH) therapies on executive functions, activities, treatment response time and adverse effects based on discernible clinical effects in children with combined type attention deficit-hyperactivity disorder (ADHD).

In this study, the functional capabilities of the patients who clinically responded well to therapy were assessed simultaneously with clinical response that may appear at different time periods and the treatment groups were compared in patients who responded to therapy by excluding patients with insufficient clinical response.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Combined type ADHD diagnosis was made by a child psychiatrist according to DSM-IV criteria through K-SADS interview with the patient and mother
The Clinical Global Impression Scale (CGI-S) was applied to determine ADHD severity and patients with a CGI-S score≥4

Exclusion criteria

Psychological, neurological or psychiatric diseases other than ADHD,
ADHD types other than combined type,
Medication that influences cognitive processes or history of such medication,
WISC-R scores <80 or >120

Treatment and study plan

Atomoxetine

Drug

the drug was initiated at a dose of 0.5 mg/kg/day which was then gradually increased at 2-week intervals and it was attempted to titrate the dose to 1.2 mg/kg/day.

Other names: STRATTERA

Methylphenidate

Drug

the drug was initiated at the lowest commercially available dose this was then increased at one-month intervals and it was attempted to titrate the dose to 1 mg/kg/day using daily doses of 36-54 mg

Other names: CONCERTA

Primary outcomes

Effects of Atx and Oros-mph on Executive Functions, measured by Wisconsin Card Sorting Test, Stroop Test TBAG Form and Visual Auditory Digit Span B

Time frame: 20 weeks

Wisconsin Card Sorting Test:WCST measures cognitive processes such as administrative control, characterization, perseveration, executive function, conceptualization, abstract thinking and reasoning, and it is mainly linked to frontal lobe .

Stroop Test TBAG Form:Stroop test is closely related to frontal lobe and many other serebral regions. It provides information about several cognitive processes such as selective attention, response inhibition, interference control and input processing speed.

Visual Auditory Digit Span B:VADS B is a test measures short-term memory, sequencing and sensorimotor integration.

The tests were applied to all patients after diagnosis and evaluations.Recovery score decreasing to 2 or 1 according to CGI-I was set as time for repetition of tests. The tests were repeated at any time of day in ATX group while they were repeated within first 60-180 minutes after ingestion of drug in OROS MPH group.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

Effects of Atomoxetine and Oros-mph on Executive Functions in Patients With Combined Type Attention Deficit Hyperactivity Disorder

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Feb 2, 2015
Registry last updated: Feb 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed