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.