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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02352051
Other study ID # 2014/580
Secondary ID
Status Completed
Phase Phase 4
First received January 14, 2015
Last updated January 30, 2015
Start date February 2014
Est. completion date October 2014

Study information

Verified date January 2015
Source TC Erciyes University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Both
Age group 7 Years to 12 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
TC Erciyes University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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