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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01220440
• Other study ID #: 3208
• Status: Completed
• Phase: Phase 4
• First received: September 28, 2010
• Last updated: October 13, 2010
• Start date: January 2006
• Est. completion date: December 2008

Study information

• Verified date: October 2010
• Source: Ostfold Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Service (NSD)Norway: Regional Ethics Commitee (REK 1)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 14 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder

Intervention

Drug:
• Methylphenidate
Methylphenidate:10mg x 3 for one week
• Placebo
Placebo: 1 pill x 2 for one week, 2 pills x 2 for one week.
• Dextroamphetamine
Dextroamphetamine: 5mg x 2 for one week, 10mg x 2 for one week

Locations

Country	Name	City	State
Norway	Ostfold Hospital Neuropsychiatric Unit	Fredrikstad	Ostfold
Norway	Østfold Hospital Neuropsychiatric Unit	Fredrikstad	Østfold

Sponsors (2)

Lead Sponsor	Collaborator
Ostfold Hospital Trust	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ADHD and ODD symptoms	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)	Every week for six weeks	No
Primary	Change in attention, motor activity and executive functioning	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).	The neuropsychological tests are administered once on each type of medication during the six week trial	No
Primary	Change in side-effects	Side-Effects Rating Scale (R. Barkley)	Once every week through the six week trial	No