Drug Class Review on Pharmacologic Treatments for ADHD - OHSU

Drug Class Review on

Pharmacologic Treatments for ADHD

Final Report

EVIDENCE TABLES

May 2006

The purpose of this report is to make available information regarding the comparative effectiveness and safety profiles of different drugs within

pharmaceutical classes. Reports are not usage guidelines, nor should they be read as an endorsement of, or recommendation for, any particular drug, use or approach. Oregon Health & Science University does not recommend or endorse

any guideline or recommendation developed by users of these reports.

Marian S. McDonagh, PharmD Kim Peterson, MS Oregon Evidence-based Practice Center Oregon Health & Science University Mark Helfand, MD, MPH, Director

Copyright ? 2006 by Oregon Health & Science University Portland, Oregon 97201. All rights reserved.

Final Report Update 1

Drug Effectiveness Review Project

TABLE OF CONTENTS

Evidence Tables Evidence Table 1. Placebo-controlled trials in preschool children and adolescents ...........3 Evidence Table 2. Quality of placebo-controlled trials in preschool children and adolescents. .........................................................................................57 Evidence Table 3. Head to Head trials in children with ADHD........................................66 Evidence Table 4. Quality assessment of head to head trials in children with ADHD ...318 Evidence Table 5. Placebo-controlled trials in children ..................................................354 Evidence Table 6. Quality of placebo-controlled trials in children .................................529 Evidence Table 7. Long-term efficacy trials....................................................................550 Evidence Table 8. Quality in long-term efficacy trials....................................................574 Evidence Table 9. Head to Head trials in adults with ADHD .........................................580 Evidence Table 10. Quality assessment of head to head trials in adults with ADHD.....604 Evidence Table 11. Placebo-controlled trials in adults with ADHD ...............................608 Evidence Table 12. Quality assessment of placebo-controlled trials in adults with ADHD.............................................................................................680 Evidence Table 13. Observational Studies - Functional Outcomes.................................696 Evidence Table 14. Quality assessment of observational studies - Functional Outcomes............................................................................711 Evidence Table 15. Observational studies - Long term safety ........................................717 Evidence Table 16. Quality of observational studies of long-term safety.......................792

Suggested Citation:

McDonagh MS, Peterson K. Drug Class Review on Pharmacologic Treatment for ADHD. Final Report. 2006.

Funding:

The funding source, the Center for Evidence-based Policy, is supported by 17 organizations, including 15 state Medicaid programs. These organizations selected the topic and had input into the Key Questions for this review. The content and conclusions of the review are entirely determined by the Evidence-based Practice Center researchers. The authors of this report have no financial interest in any company that makes or distributes the products reviewed in this report.

ADHD Drugs

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Final Report Update 1

Evidence Table 1. Placebo-controlled trials in preschool children and adolescents

Drug Effectiveness Review Project

Author Year (Quality) Preschool chidren Schleifer 1975 (Fair)

Study Design Setting

RCT DB crossover

Eligibility criteria

Preschool children diagnosed as hyperactive participated in this study

Comorbidity NR

Barkley 1988 (Fair)

RCT DB crossover

1. Parent and/or teacher complaints of short attention span, NR poor impulse control and restlessness 2. Age of onset of problem behavior prior to 6 years 3. A duration of problem behavior for at least 12 months 4. Scores on the Hyperactivity Index of the Conners Parent Rating Scale and the Werry-Weiss-Peters Activity Rating Scale greater than two SDs above the mean for same-age, same-sex normal children 5. Scores on the Home Situations Questionnaire indicating that the child posed behavior problems in at least eight of the 16 situations described on the questionnaire to establish pervasiveness of behavior problems 6. Absence of epilepsy, severe language delay, deafness, blindness, autism, psychosis or gross brain damage as estabished through developmental/medical histories and observation of the children

ADHD Drugs

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Final Report Update 1

Evidence Table 1. Placebo-controlled trials in preschool children and adolescents

Author Year (Quality) Preschool chidren Schleifer 1975 (Fair)

Interventions and total daily dose Duration Dosing schedule

methylphenidate: 2.5 mg - 20mg q.a.m and 10mg at lunch (mean dose = 5mg bid) Duration: 14-21 days

Run-in/Washout Period

NR/NR

Drug Effectiveness Review Project

Allowed other medications/ interventions NR

Barkley 1988

methylphenidate 0.15mg/kg bid or 0.5mg/kg bid

2 days/NR

NR

(Fair)

Duration: 7-10 days for each condition (baseline, placebo, low dose,

high dose)

Timing: NR

ADHD Drugs

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Final Report Update 1

Evidence Table 1. Placebo-controlled trials in preschool children and adolescents

Author Year (Quality) Preschool chidren Schleifer 1975 (Fair)

Method of Outcome Assessment and Timing of Assessment

Observation Hyperactivity Rating Scale

Timing: before and after the intervention

Age Gender Ethnicity

Mean age=4.08 years Gender: 89.3% male Ethnicity: NR

Barkley 1988 (Fair)

A free play (20 mins) and 5 task (20 mins total): mother-child Mean age=3.9 years

interactions were videotaped and separate coding of the

Gender: 70.3% male

interactions was done using the Response Class Matrix.

Ethnicity: NR

Timing: the last day of each drug condition

Drug Effectiveness Review Project

ADHD Drugs

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