Effects of Atx and Oros-mph on Executive Functions

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

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).

Study Overview

• Status: Completed
• Conditions: Executive Dysfunction
• Intervention / Treatment: Drug: Atomoxetine; Drug: methylphenidate

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Atomoxetine group; 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.	Drug: Atomoxetine; 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
Active Comparator: Methylphenidate group; 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.	Drug: methylphenidate; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	20 weeks

Collaborators and Investigators

• Sponsor: TC Erciyes University
• Investigators: Principal Investigator: bedia ince taşdelen, MD, TC Erciyes University

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: January 14, 2015
• First Submitted That Met QC Criteria: January 30, 2015
• First Posted (Estimate): February 2, 2015

Study Record Updates

• Last Update Posted (Estimate): February 2, 2015
• Last Update Submitted That Met QC Criteria: January 30, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: executive functions; attention deficit-hyperactivity disorder (ADHD).
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Adrenergic Uptake Inhibitors; Methylphenidate; Atomoxetine Hydrochloride
• Other Study ID Numbers: 2014/580