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

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Drug: Methylphenidate; Drug: Placebo; Drug: Dextroamphetamine

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• Norway
  • Ostfold
    • Fredrikstad, Ostfold, Norway, 1605
      • Ostfold Hospital Neuropsychiatric Unit
  • Østfold
    • Fredrikstad, Østfold, Norway, 1605
      • Østfold Hospital Neuropsychiatric Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Change in side-effects	Side-Effects Rating Scale (R. Barkley)	Once every week through the six week trial

Collaborators and Investigators

• Sponsor: Ostfold Hospital Trust
• Collaborators: University of Oslo
• Investigators: Study Director: Arne K. Henriksen, Phd, Ostfold Hospital Trust

Publications and helpful links

General Publications

• Ramtvedt BE, Aabech HS, Sundet K. Minimizing adverse events while maintaining clinical improvement in a pediatric attention-deficit/hyperactivity disorder crossover trial with dextroamphetamine and methylphenidate. J Child Adolesc Psychopharmacol. 2014 Apr;24(3):130-9. doi: 10.1089/cap.2013.0114. Epub 2014 Mar 25.
• Ramtvedt BE, Roinas E, Aabech HS, Sundet KS. Clinical gains from including both dextroamphetamine and methylphenidate in stimulant trials. J Child Adolesc Psychopharmacol. 2013 Nov;23(9):597-604. doi: 10.1089/cap.2012.0085. Epub 2013 May 9.

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: September 28, 2010
• First Submitted That Met QC Criteria: October 13, 2010
• First Posted (Estimate): October 14, 2010

Study Record Updates

• Last Update Posted (Estimate): October 14, 2010
• Last Update Submitted That Met QC Criteria: October 13, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: Children; ADHD; Crossover; Double Blind; Placebo; Methylphenidate; Dextroamphetamine; Neuropsychological tests; Behavioural Questionnaires
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Methylphenidate; Dextroamphetamine
• Other Study ID Numbers: 3208