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Effects of Atx and Oros-mph on Executive Functions

Primary Purpose

Executive Dysfunction

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Atomoxetine
methylphenidate
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Executive Dysfunction focused on measuring attention deficit-hyperactivity disorder (ADHD)., executive functions

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Atomoxetine group

    Methylphenidate group

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 14, 2015
    Last Updated
    January 30, 2015
    Sponsor
    TC Erciyes University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02352051
    Brief Title
    Effects of Atx and Oros-mph on Executive Functions
    Official Title
    Effects of Atomoxetine and Oros-mph on Executive Functions in Patients With Combined Type Attention Deficit Hyperactivity Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2014 (undefined)
    Primary Completion Date
    October 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    TC Erciyes University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Executive Dysfunction
    Keywords
    attention deficit-hyperactivity disorder (ADHD)., executive functions

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    43 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Atomoxetine group
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Methylphenidate group
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Atomoxetine
    Other Intervention Name(s)
    STRATTERA
    Intervention 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.
    Intervention Type
    Drug
    Intervention Name(s)
    methylphenidate
    Other Intervention Name(s)
    CONCERTA
    Intervention 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
    Primary Outcome Measure Information:
    Title
    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
    Description
    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.
    Time Frame
    20 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    bedia ince taşdelen, MD
    Organizational Affiliation
    TC Erciyes University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Effects of Atx and Oros-mph on Executive Functions

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