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

NCT ID: NCT01220440

Last Updated: 2010-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2008-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Methylphenidate

Intervention Type: DRUG

Methylphenidate:10mg x 3 for one week

Placebo

Intervention Type: DRUG

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

Dextroamphetamine

Intervention Type: DRUG

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

Interventions

Methylphenidate

Methylphenidate:10mg x 3 for one week

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Dextroamphetamine

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

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

Ostfold Hospital Trust

OTHER

Sponsor Role: lead

Responsible Party

Ostfold Hospital Trust

Principal Investigators

Arne K. Henriksen, Phd

Role: STUDY_DIRECTOR

Ostfold Hospital Trust

Locations

Ostfold Hospital Neuropsychiatric Unit

Fredrikstad, Østfold fylke, Norway

Østfold Hospital Neuropsychiatric Unit

Fredrikstad, Østfold fylke, Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 24666268 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23659360 (View on PubMed)

Other Identifiers

3208

Identifier Type: -

Identifier Source: org_study_id