Effects of Atx and Oros-mph on Executive Functions

NCT02352051 | Completed Phase 4

• 1 other identifier: 2014/580
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Executive Dysfunction

Keywords

attention deficit-hyperactivity disorder (ADHD).; executive functions

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Atomoxetine group

ACTIVE COMPARATOR

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

Methylphenidate group

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: STRATTERA

Atomoxetine group

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

Also known as: CONCERTA

Methylphenidate group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine Hydrochloride; Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• bedia ince taşdelen, MD

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 14, 2015
• First Posted: February 2, 2015
• Study Start: February 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 2, 2015

Record last verified: 2015-01