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American Academy of Pediatrics
Review Article

Medications for Adolescents and Young Adults With Autism Spectrum Disorders: A Systematic Review

Dwayne Dove, Zachary Warren, Melissa L. McPheeters, Julie Lounds Taylor, Nila A. Sathe and Jeremy Veenstra-VanderWeele
Pediatrics October 2012, 130 (4) 717-726; DOI: https://doi.org/10.1542/peds.2012-0683
Dwayne Dove
Departments of aPediatrics,
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Zachary Warren
Departments of aPediatrics,
bPsychiatry,
cVanderbilt Kennedy Center Treatment and Research Institute for Autism Spectrum Disorders;
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Melissa L. McPheeters
dObstetrics and Gynecology, and
eVanderbilt Evidence-based Practice Center, Institute for Medicine and Public Health, Vanderbilt University Medical Center;
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Julie Lounds Taylor
Departments of aPediatrics,
fVanderbilt Kennedy Center, Vanderbilt University, Nashville, Tennessee
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Nila A. Sathe
eVanderbilt Evidence-based Practice Center, Institute for Medicine and Public Health, Vanderbilt University Medical Center;
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Jeremy Veenstra-VanderWeele
Departments of aPediatrics,
bPsychiatry,
cVanderbilt Kennedy Center Treatment and Research Institute for Autism Spectrum Disorders;
gPharmacology;
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  • FIGURE 1
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    FIGURE 1

    Disposition of articles identified for review. aNumbers do not tally because studies could be excluded for multiple reasons. bOne study4 addresses an antipsychotic and an SRI.

Tables

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    TABLE 1

    Inclusion and Exclusion Criteria

    CategoryCriteria
    Study populationAdolescents or young adults (ages 13–30 years) with ASD (autistic disorder, Asperger syndrome, PDD-NOS) or families/caregivers of individuals with ASD between the ages of 13 and 30 years
    InterventionsInterventions aimed at ameliorating core symptoms of ASD, affecting independent functioning, adaptive behavior, or the transition process, or targeting family outcomes
    ComparatorsPlacebo
    Other intervention
    OutcomesSocial skills/interaction, language and communication, repetitive and other maladaptive behaviors, motor outcomes, psychological distress, adaptive skills development, academic skills development, and family outcomes, including family distress and family satisfaction
    Time periodStudies published from 1980–present with no limits on timing of outcomes
    SettingAny setting, including educational, residential, and clinic
    Publication languagesEnglish only
    Admissible evidence (study design and other criteria)
     Admissible designControlled trials, observational studies including prospective and retrospective cohort studies, prospective and retrospective case series
     Study sizeAt least 20 total individuals between 13 and 30 years of age with ASD or family members of such individuals
     Other criteriaOriginal research studies that provide sufficient detail regarding methods and results to enable use and adjustment of the data and results
    Patient populations must include adolescents or young adults (13–30 years of age) with ASD or families/caregivers of individuals with ASD between the ages of 13 and 30 years
    Studies must address 1 or more of the following: (1) treatment modality aimed at modifying ASD core symptoms, common comorbidities, family-related outcomes, or assisting with transitional issues; and (2) outcomes (including harms) related to interventions for ASD
    Studies must include extractable data on relevant outcomes, including data presented in text or tables (versus solely in figures)
    Studies must present aggregate data (versus only data for each individual participant)
    • PDD-NOS, pervasive developmental disorder–not otherwise specified.

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    TABLE 2

    Domains Used to Assess Strength of Evidence

    DomainDescription
    Risk of biasReflects issues in study design and conduct that could result in biased estimates of effect
    ConsistencyReflects similarity of effect sizes seen across studies. Consistency cannot be assessed when only 1 study is available
    DirectnessReflects the relationship between the intervention and the ultimate health outcome of interest
    PrecisionReflects the level of certainty around the effect observed
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    TABLE 3

    Overview of Studies

    CharacteristicRCTs (n = 5)Prospective Case Series (n = 2)Retrospective Case Series (n = 1)Total Literature (N = 8a)
    Intervention
     Antipsychoticsa3003
     SRIsa2215
     Opioid receptor antagonist1001
    Treatment duration, mo
     >1 to ≤3 4206
     >3 to ≤6 1001
     >6 to ≤120011
    Study population
     United States3216
     Europe1001
     Other1001
    Total participants1727723272
    • ↵a One study assessed both an antipsychotic agent and an SRI.

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    TABLE 4

    Key Outcomes of Studies Assessing Medication Treatments in Adolescents and Young Adults With ASD

    Study (Author, Year, Country
Groups, N; Enrollment/N Final; Study, Quality)Age, y, Mean ± SDIQ, Mean ± SDOutcome Measure/ Baseline Scores, Mean ± SDOutcome Measure/Posttreatment Scores, Mean ± SD
    Antipsychotic agents
     Hellings et al,4 2006; United States; G1 + G2: placebo phase, then dose risperidone, followed by crossover to the other risperidone dose, then another placebo phase; placebo I phase: 3–5 wk of placebo, n = 40; acute-dose phase: G1 low-dose (n = 39) or G2 high-dose risperidone (n = 36); placebo II phase: 3–5 wk of placebo, n = 33; maintenance phase: optimal dose risperidone, n = 32; poor qualityG1 + G2: 22 ± 13.1NR, 40/40 with intellectual disabilityABC Irritability: G1 + G2, placebo I phase: 19.16 ± 9.96; G1 + G2, placebo II phase: 18.23 ± 12.36ABC Irritability: G1, Low-dose acute phase: 11.15 ± 9.28; G2, High-dose acute phase: 13.31 ± 8.92; P = .13 G1 versus G2, P = .0002 G1 + G2 acute phase versus G1 + G2 placebo II; maintenance phase scores only reported graphically
     Remington et al,5 2001; Canada; G1: clomipramine; G2: haloperidol; G3: placebo; Overall N: 37/36; fair qualityOverall: 16.3 (SD NR)NRCARS: overall, 41.8 ± 7.1CARS: G1: 37.8 ± 8.7; G2: 36.7 ± 6.1; G3: 39.4 ± 7.0; P < .05, G2 versus baseline; ABC reported only graphically
     McDougle et al,6 1998; United States; G1: risperidone, 15/12; G2: placebo,16/12; G2a: open-label risperidone after placebo, n = 15; fair qualityG1 + G2: 28.1 ± 7.3G1 + G2: 54.6 ± 23.9Y-BOCS, compulsion: G1: 16.5 ± 3.58; G2: 14.29 ± 3.50; G2a: 14.27 ± 2.92; SIB-Q: G1: 47.8 ± 19.5; G2: 37.7 ± 11.9; G2a: 32.43 ± 15.89Y-BOCS, compulsion: G1: 12.77 ± 3.63; G2: 14.35 ± 3.02; P < .001, G1 versus G2; G2a: 11.47 ± 3.64; P < .03, G2a versus baseline; SIB-Q: G1: 24.2 ± 9.5; G2: 32.8 ± 15.0; P < .001, G2 versus G1; G2a: 23.07 ± 13.45; P < .05, G2a versus baseline
    SRIs
     Remington et al,5 2001; Canada; G1: clomipramine; G2: haloperidol; G3: placebo; Overall N: 37/36; fair qualityOverall: 16.3 (SD NR)NRCARS; Overall: 41.8±7.1CARS: G1: 37.8 ± 8.7; G2: 36.7 ± 6.1; G3: 39.4 ± 7.0; P < .05, G2 versus baseline; ABC reported only graphically
     McDougle et al,8 1998; United States; G1: sertraline, n = 42/37; G1a: AD; G1b: AS; G1c: PDD-NOS; poor quality26.1 ± 5.860.5 ± 22.7 (28 with intellectual disability)Y-BOCS, total score: G1a: 16.5 ± 6.7; G1b: 25.7 ± 4.1; G1c: 18.2 ± 4.8; Vineland Maladaptive Behavior: G1a: 27.0 ± 9.4; G1b: 19.8 ± 8.6; G1c: 28.3 ± 10.8; SIB-Q: G1a: 32.7 ± 16.5; G1b: 17.5 ± 7.7; G1c: 36.2 ± 16.4;Y-BOCS, total score: G1a: 11.5 ± 5.8; G1b: 27.8 ± 5.3; G1c: 14.8 ± 5.7; P = .005, G1 versus baseline; Vineland Maladaptive Behavior Scale: G1a: 13.8 ± 6.0; G1b: 20.2 ± 8.2; G1c: 19.5 ± 9.1; P = .0001, G1 versus baseline SIB-Q: G1a: 15.5 ± 9.5; G1b: 18.8 ± 7.7; G1c: 20.2 ± 12.8; P = .0001, G1 versus baseline
     Brodkin et al,9 1997; United States; G1: clomipramine, 35/33; G1a: responders, n = 18; G1b: nonresponders, n = 15; poor qualityG1: 30.2 ± 7.0G1: 64.6 ± 27.2Y-BOCS, total score: G1a: 18.7 ± 6.8; G1b: 17.9 ± 6.2; Y-BOCS, compulsion subscale: G1a: 13.7 ± 3.3; G1b: 13.9 ± 2.5; Y-BOCS, obsession subscale: G1a: 10 ± 6.8; G1b: 6.7 ± 6.2; Brown Aggression Scale: G1a: 10.6 ± 7.4; G1b: 6.5 ± 4.1Y-BOCS, total score: G1a: 9.1 ± 3.0; G1b: 17.3 ± 7.8; P < .001, G1 versus baseline; P < .001, G1a versus G1b; Y-BOCS, compulsion subscale: G1a: 6.9 ± 2.1; G1b: 12.5 ± 3.3; P < .001, G1 versus baseline; P < .001, G1a versus G1b; Y-BOCS, obsession subscale: G1a: 4.4 ± 2.8; G1b: 8 ± 6.6; P < .001, G1 versus baseline; P < .001, G1a versus G1b; Brown Aggression Scale: G1a: 3.7 ± 3.6; G1b: 6.4 ± 4.6; P < .001, G1 versus baseline; P < .001, G1a versus G1b
     McDougle et al,7 1996; United States; G1: fluvoxamine, 15/15; G2: placebo, 15/15; fair qualityG1: 30.1 ± 7.1; G2: 30.1 ± 8.4G1: 82.5 ± 26.8; G2: 77.3 ± 33.1Y-BOCS, total score: G1: 21.4 ± 7.3; G2: 21.5 ± 6.8Y-BOCS, total score: G1: 13.7 ± 9.1; G2: 21.9 ± 6.7; P < .003, G1 versus G2; Data for Vineland Maladaptive Behavior and Brown Aggression Scale were not reported, although statistically significant improvements were noted
     Cook et al,10 1992; United States; G1: fluoxetine, 23/23; poor quality15.9 ± 6.2NR, 19 with intellectual disabilityCGI-S, total: 5.7 ± 0.8; CGI-S, compulsion: 5.5 ± 1.5CGI-S, total: 4.9 ± 1.1; P < .002, G1 versus baseline; CGI-S, compulsion: 4.7 ± 1.6; P < .005, G1 versus baseline
    Opioid receptor antagonist
     Willemsen-Swinkels et al,11 1995; the Netherlands; G1 + G2: 4-week naltrexone phase for cohorts 1 (50 mg daily) and 2 (150 mg daily) (ASD patients only); G3 + G4: 4-week placebo phase for cohorts 1 and 2 (ASD patients only); overall N: 33/31; fair qualityOverall: 29 ± 6.0NRABC Stereotypy: G1 + G2: 9.7 ± 4.7; G3 + G4: 8.3 ± 5.2ABC Stereotypy: G1 + G2: 10.0 ± 4.7; G3 + G4: 9.0 ± 4.8; P = .018, G1 + G2 versus G3 + G4
    • AD, autistic disorder; AS, Asperger syndrome; CARS, Childhood Autism Rating Scale; CGI-S, Clinical Global Impression of Severity; G, group; NR, not reported; PDD-NOS, pervasive developmental disorder–not otherwise specified; SIB-Q, Self-Injurious Behavior Questionnaire; Y-BOCS, Yale-Brown Obsessive Compulsive Scale.

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Medications for Adolescents and Young Adults With Autism Spectrum Disorders: A Systematic Review
Dwayne Dove, Zachary Warren, Melissa L. McPheeters, Julie Lounds Taylor, Nila A. Sathe, Jeremy Veenstra-VanderWeele
Pediatrics Oct 2012, 130 (4) 717-726; DOI: 10.1542/peds.2012-0683

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Medications for Adolescents and Young Adults With Autism Spectrum Disorders: A Systematic Review
Dwayne Dove, Zachary Warren, Melissa L. McPheeters, Julie Lounds Taylor, Nila A. Sathe, Jeremy Veenstra-VanderWeele
Pediatrics Oct 2012, 130 (4) 717-726; DOI: 10.1542/peds.2012-0683
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