Comparing the Efficacy of Methylphenidate, Dextroamphetamine and Placebo in Children Diagnosed With ADHD

Sponsor

Ostfold Hospital Trust (Other)

Overall Status

Completed

CT.gov ID

NCT01220440

Collaborator

University of Oslo (Other)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study compares the efficacy of methylphenidate, dextroamphetamine and placebo on neuropsychological functioning and behavioral symptoms in 36 children diagnosed with ADHD within a double-blind cross-over design over six weeks. The assessment of ADHD followed formalized guidelines and a diagnosis of ADHD was based on DSM-IV criteria. A neuropsychological testbattery and four behavioral questionnaires were selected as efficacy variables. The neuropsychological testbattery includes Qb-test (visual attention, inhibitory control, motor activity), Score (auditory attention), Stroop Test (processing speed, inhibitory control) and Grooved Pegboard (motor speed). The participants were tested once on each type of medication. The four questionnaires are: a)Side-Effects Rating Scale (completed by a parent at the end of each of the six weeks), b)Self-Report Questionnaire (completed by the child at the end of each of the six weeks), c)Parent and Teacher Questionnaire(completed by a parent and a teacher Monday till Friday through every week), Test Performance Questionnaire (completed by the child immediately after each of the three test sessions).

Main hypothesis: A trial including both dextroamphetamine(Dex) and methylphenidate(Met) will provide better results than a trial including only Met. a)Met and Dex are efficient as treatment for ADHD compared to placebo, albeit Dex has moderately better effect compared to Met. b)At an individual level some of the participants will show positive response to one type of stimulants and no response, mixed response or adverse response to the other type of stimulant. c)Neuropsychological tests and behavioral questionnaires are moderately in agreement but also add unique information in the assessment of the effect of stimulants. d)Qb-test is sensitive and valid as a measure of the effect of stimulants.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder	Drug: Methylphenidate Drug: Placebo Drug: Dextroamphetamine	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparing the Efficacy of Methylphenidate, Dextroamphetamine and Placebo in Children Diagnosed With ADHD

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Methylphenidate, Dexamphetamine, Placebo The 36 participants received each of the three medications for two weeks. Six different medication sequences are possible. The participants are randomly chosen for each of the six sequences in a way that allow six participants into each of the six sequences to balance the sequences.	Drug: Methylphenidate Methylphenidate:10mg x 3 for one week Drug: Placebo Placebo: 1 pill x 2 for one week, 2 pills x 2 for one week. Drug: Dextroamphetamine Dextroamphetamine: 5mg x 2 for one week, 10mg x 2 for one week

Arm

Intervention/Treatment

Experimental: Methylphenidate, Dexamphetamine, Placebo

The 36 participants received each of the three medications for two weeks. Six different medication sequences are possible. The participants are randomly chosen for each of the six sequences in a way that allow six participants into each of the six sequences to balance the sequences.

Drug: Methylphenidate

Methylphenidate:10mg x 3 for one week

Drug: Placebo

Placebo: 1 pill x 2 for one week, 2 pills x 2 for one week.

Drug: Dextroamphetamine

Dextroamphetamine: 5mg x 2 for one week, 10mg x 2 for one week

Outcome Measures

Primary Outcome Measures

Change in ADHD and ODD symptoms [Every week for six weeks]
Parent and Teacher Questionnaire (completed monday till friday every week) Self-Report Questionnaire (completed once every week) Test Performance Questionnaire (completed by the child after each testsession)
Change in attention, motor activity and executive functioning [The neuropsychological tests are administered once on each type of medication during the six week trial]
QB test is a computer based continuous performance test (visual attention and motor activity). Score!from Test of Everyday Attention - Childrens Edition (auditory attention). C. Golden version of Stroop Test(prosessing-speed and inhibitory control). Grooved Pegboard from the Hallstead battery (motor speed).
Change in side-effects [Once every week through the six week trial]
Side-Effects Rating Scale (R. Barkley)

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age from 9.0 to 14.0.
ADHD diagnosis following assessment at a child & adolescent outpatient clinic.
Clarification for stimulant treatment.

Exclusion Criteria:

Moderate or severe mental retardation.
Psychosis.
Proven brain damage.
Sensory deficits and/or motor impairments that make the individual in question unsuitable for the relevant tests.
Epilepsy.
The child has previously been prescribed stimulant medication or is being treated with such medication.
The child commutes between parents or there are other factors that substantially reduce the possibility of obtaining reliable observations from parents (The child needs to live in one place through out the whole trial since otherwise might severely influence the child's behaviour and the observations).