Effects of Atx and Oros-mph on Executive Functions

TC Erciyes University

Status and phase: Completed; Phase 4

Conditions: Executive Dysfunction

Treatments: Drug: methylphenidate; Drug: Atomoxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT02352051

2014/580

Details and patient eligibility

About

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).

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 7 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Atomoxetine group

Active Comparator group

Description:

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.

Treatment:

Drug: Atomoxetine

Methylphenidate group

Active Comparator group

Description:

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.

Treatment:

Drug: methylphenidate