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

NCT01220440 | Completed Phase 4

• 1 other identifier: 3208
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; Children; Methylphenidate; Dextroamphetamine; Placebo; Crossover; Double Blind; Neuropsychological tests; Behavioural Questionnaires

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Methylphenidate, Dexamphetamine, Placebo

EXPERIMENTAL

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; Drug: Placebo; Drug: Dextroamphetamine

Interventions

Methylphenidate DRUG

Methylphenidate:10mg x 3 for one week

Methylphenidate, Dexamphetamine, Placebo

Placebo DRUG

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

Methylphenidate, Dexamphetamine, Placebo

Dextroamphetamine DRUG

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

Methylphenidate, Dexamphetamine, Placebo

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ostfold Hospital Trust: lead
• University of Oslo: collaborator

Study Sites (2)

Ostfold Hospital Neuropsychiatric Unit

Fredrikstad, Østfold fylke, 1605, Norway

Location

Østfold Hospital Neuropsychiatric Unit

Fredrikstad, Østfold fylke, 1605, Norway

Location

Related Publications (2)

• 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.

  PMID: 24666268 DERIVED

• 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.

  PMID: 23659360 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate; Dextroamphetamine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines

Study Officials

• Arne K. Henriksen, Phd

  Ostfold Hospital Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 28, 2010
• First Posted: October 14, 2010
• Study Start: January 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: October 14, 2010

Record last verified: 2010-10

Locations

NO (2)