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Evidence Tables Drug Class Review Pharmacologic Treatments for Attention Deficit Hyperactivity Disorder Final Update 4 Evidence Tables December 2011 The purpose of Drug Effectiveness Review Project reports is to make available information regarding the comparative clinical effectiveness and harms of different drugs. 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. Update 3: October 2009 Update 2: November 2007 Update 1: May 2006 Original Report: September 2005 The literature on this topic is scanned periodically. Update 4 Authors: Marian S. McDonagh, PharmD Kim Peterson, MS Sujata Thakurta, MPA:HA Allison Low, BA Drug Effectiveness Review Project Marian McDonagh, PharmD, Principal Investigator Oregon Evidence-based Practice Center Mark Helfand, MD, MPH, Director Oregon Health & Science University Copyright © 2011 by Oregon Health & Science University Portland, Oregon 97239. All rights reserved. Final Update 4 Evidence Tables Drug Effectiveness Review Project The medical literature relating to this topic is scanned periodically. (See http://www.ohsu.edu/xd/research/centers-institutes/evidence-based-policy- center/derp/documents/methods.cfm for description of scanning process). Prior versions of this report can be accessed at the DERP website. Attention deficit hyperactivity disorder 2 of 555 Final Update 4 Evidence Tables Drug Effectiveness Review Project TABLE OF CONTENTS Abbreviations used in evidence tables ...................................................................................................... 4 Evidence Table 1. Data abstraction of head-to-head trials in children and adults with attention deficit hyperactive disorder ................................................................................................................................... 7 Evidence Table 2. Quality assessment of head-to-head trials in children and adults with attention deficit hyperactivity disorder ............................................................................................................................. 116 Evidence Table 3. Data abstraction of placebo-controlled trials in children .......................................... 136 Evidence Table 4. Quality assessment of placebo-controlled trials in children ..................................... 276 Evidence Table 5. Data abstraction of long-term efficacy trials ............................................................ 302 Evidence Table 6. Quality assessment of long-term efficacy trials ....................................................... 329 Evidence Table 7. Data abstraction of placebo-controlled trials in adults with attention deficit hyperactivity disorder ............................................................................................................................. 333 Evidence Table 8. Quality assessment of placebo-controlled trials in adults with attention deficit hyperactivity disorder ............................................................................................................................. 450 Evidence Table 9. Data abstraction of observational studies ................................................................ 468 Evidence Table 10. Quality assessment of observational studies ........................................................ 540 Evidence Table 11. Data abstraction of abuse and diversion studies ................................................... 552 Evidence Table 12. Quality assessment of abuse and diversion studies .............................................. 554 Attention deficit hyperactivity disorder 3 of 555 Final Update 4 Evidence Tables Drug Effectiveness Review Project Abbreviations used in evidence tables Abbreviation Term ACDS ADHD Clinical Diagnostic Scale Investigator-rated Attention Deficit and Disruptive Behavior Disorder ADDB-Inv Instrument ADHD Attention deficit hyperactivity disorder ADHD-AM-RS Attention Deficit Hyperactivity Disorder - Rating Scale (morning version) ADHD-RS-IV Attention Deficit Hyperactivity Disorder - Rating Scale IV AISRS Adult ADHD Investigator Symptom Rating Scale ASQ Abbreviated Symptom Questionnaire bid Twice daily BMI Body mass index BPM Beats per minute CCT Controlled clinical trial CD Conduct disorder CGAS Children's Global Assessment Scale CGI Clinical global impression CGI-I Clinical global impression-Improvement CHQ Child Health Questionnaire CI Confidence interval CLON Clonidine CMTD Chronic multiple tic disorder CNS Central nervous system CPRS-48 Connors' Parent Rating Scale CPRS-R:L Conners' Parent Rating Scale-Revised: Long Form CR Controlled release CTRS-39 Connors' Teacher Rating Scale CTRS-L Conners' Teacher Rating Scale-Long Form CTRS-R Connors' Teacher Rating Scale-Revised CV Cardiovascular CVS Cardiovascular system d Day DB Double-blind DBD-NOS Disruptive behavior disorder behavior, not otherwise specified DBP Diastolic blood pressure DEX Dextroamphetamine DICA Diagnostic Instrument of Childhood and Adolescence dL Deciliter d-MPH Dexmethylphenidate DSM-IV Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition ECG Electrocardiogram EEG Electroencephalogram EF Ejection fraction ER Extended release FDA US Food and Drug Administration FU Follow-up g Gram GAD Generalized anxiety disorder Attention deficit hyperactivity disorder 4 of 555 Final Update 4 Evidence Tables Drug Effectiveness Review Project Abbreviation Term GAF Global Assessment of Functioning GI Gastrointestinal GP General practitioner GTRS Global Tic Rating Scale h Hour HARS Hamilton Anxiety Rating Scale HDL-C High density lipoprotein cholesterol HDRS Hamilton Depression Rating scale HMO Health maintenance organization HR Hazard ratio HRQOL Health-related quality of life ICD-10 International Classification of Diseases, Tenth Revision ICD-9 International Classification of Diseases, Ninth Revision IQ Intelligence quotient IQR Interquartile range IR Immediate release ITT Intent-to-treat K-SADS-PL Kiddie-SADS- Present and Lifetime Diagnostic Interview L Liter LA Long acting LDL-C Low-density lipoprotein cholesterol LOCF Last Observation Carried Forward LS means Least squares means MANCOVA Multivariate analysis of covariance MAS Mixed Amphetamine Salts mcg Microgram mg Milligram min Minute mL Milliliter mo Month MPH Methylphenidate MPH MR Methylphenidate modified release MTS Methylphenidate transdermal formulation N Sample size (entire sample) n Subgroup sample size NA Not applicable NCBRF-TIQ Nisonger Child Behavior Rating Form NR Not reported NS Not significant NSD No significant difference OCD Obsessive-compulsive disorder ODD Oppositional Defiant Disorder OR Odds ratio OROS Osmotic release oral system P P value P Placebo PCT Placebo-controlled trial Attention deficit hyperactivity disorder 5 of 555 Final Update 4 Evidence Tables Drug Effectiveness Review Project Abbreviation Term PDD-NOS Pervasive developmental disorder, not otherwise specified PERMP-A Permanent Product Measure of Performance-Attempted PERMP-C Permanent Product Measure of Performance-Correct PGA Parent Global Assessment PPY Per person year qd Once daily QOL Quality of life RCT Randomized controlled trial RR Relative risk SAD Separation Anxiety Disorder SAERS Barkeley Dtimulant Adverse Event Rating Scale SB Single-blind SBP Systolic blood pressure SD Standard deviation SE Standard error SKAMP-A Swanson, Kotkin, Agler, M-Flynn and Pelham-Attention SKAMP-D Swanson, Kotkin, Agler, M-Flynn and Pelham-Deportment SNAP Swanson Nolan and Pelham Rating Scale-Revised SR Sustained release SSEC Stimulant Side Effects Checklist SUD Substance Use Disorder tid Three times daily URTI Upper respiratory tract infection VAS Visual analog scale vs. Compared with (versus) WD Withdrawal WURS Wender Utah Rating Scale XR Extended release y Year YGTSS Yale Global Tic Severity Scale YQOL-R Youth Quality of Life-Research Version Attention deficit hyperactivity disorder 6 of 555 Final Update 4 Evidence Tables Drug Effectiveness Review Project Evidence Table 1. Data abstraction of head-to-head trials in children and adults with attention deficit hyperactivity disorder Author Year Country Allowed other Age Number withdrawn/ Trial name medications/ Gender Other population lost to follow- Quality rating Population Interventions interventions Ethnicity characteristics N up/analyzed Amiri 2008 Patients were 6-15 years old who met Modafinil NR Mean age: 9.2 NR 60 5 withdrew: 2 from Iran the DSM-IV-TR diagnostic criteria for Dependant on weight: 200mg/day years (Modafinil) modafinil group vs 3 ADHD. They had total and/or for <30 kg and 300mg/day for >30 vs 8.96 years from subscale scores on ADHD-RS-IV, kg (Methylphenidate) methylphenidate school version at least 1.5 SD above 78.3% male group norms for patient's age and gender. Methylphenidate 100% Persian Patients were excluded if they had a Dependant on weight: 20mg/day Lost to FU=NR history or current diagnosis of for <30 kg and 30mg/day for >30 Analyzed=60 pervasive developmental disorders, kg schizophrenia or other psychiatric disorders; any current psychiatric comorbidity that required pharmacotherapy; any evidence of suicide risk and mental retardation; they had a clinically significant chronic medical condition, including organic brain disorder, seizures and current abuse or dependence on drugs within 6 months; hypertension, hypotension and habitual consumption of more than
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