Aripiprazole for autism spectrum disorders (ASD)

Lauren E Hirsch; Tamara Pringsheim

doi:10.1002/14651858.CD009043.pub3

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Analysis 1.1

Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 1 Aberrant Behavior Checklist (ABC) ‐ Irritability subscale: mean score changes.

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Analysis 1.2

Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 2 Aberrant Behavior Checklist (ABC) ‐ Hyperactivity subscale: mean score changes.

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Analysis 1.3

Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 3 Aberrant Behavior Checklist (ABC) ‐ Stereotypy subscale: mean score changes.

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Analysis 1.4

Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 4 Aberrant Behavior Checklist (ABC) ‐ Inappropriate Speech subscale: mean score changes.

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Analysis 1.5

Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 5 Aberrant Behavior Checklist (ABC) ‐ Lethargy/Withdrawal subscale: mean score changes.

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Analysis 1.6

Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 6 Clinical Global Impression (CGI) ‐ Severity subscale: mean scores.

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Analysis 1.7

Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 7 Clinical Global Impression (CGI) ‐ Improvement subscale: mean scores.

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Analysis 1.8

Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 8 Any extrapyramidal symptom event (side effect).

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Analysis 1.9

Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 9 Children's Yale‐Brown Obsessive Compulsive Scale (CY‐BOCS): mean scores.

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Analysis 1.10

Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 10 Clinically relevant weight gain (side effect).

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Analysis 1.11

Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 11 Weight gain (side effect).

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Analysis 1.12

Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 12 Body mass index (BMI) change from baseline (side effect).

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Analysis 1.13

Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 13 Elevated fasting triglycerides at endpoint (side effect).

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Analysis 1.14

Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 14 Elevated low‐density lipoprotein at endpoint (side effect).

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Analysis 1.15

Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 15 Decreased high‐density lipoprotein at endpoint (side effect).

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Analysis 1.16

Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 16 Elevated fasting blood glucose at endpoint (side effect).

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Analysis 1.17

Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 17 Sedation (side effect).

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Analysis 1.18

Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 18 Drooling (side effect).

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Analysis 1.19

Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 19 Tremor (side effect).

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Aripiprazole compared with placebo for autism spectrum disorders (ASD)*
Patient or population: children/youth with ASD Settings: ambulatory care Intervention: aripiprazole Comparison: placebo
Outcomes	Effect (95% confidence interval)	Number of participants (studies)	Quality of the evidence (GRADE)	Comments
ABC ‐ Irritability subscale Mean score changes 8 weeks of treatment	MD ‐6.17 (‐9.07 to ‐3.26) points relative to placebo, in favour of aripiprazole	308 (2)	⊕⊕⊕⊝ Moderate^a	‐
ABC ‐ Hyperactivity subscale Mean score changes 8 weeks of treatment	MD ‐7.93 (‐10.98 to ‐4.88) points relative to placebo, in favour of aripiprazole	308 (2)	⊕⊕⊕⊝ Moderate^a	‐
ABC ‐ Stereotypy subscale Mean score changes 8 weeks of treatment	MD ‐2.66 (‐3.55 to ‐1.77) points relative to placebo, in favour of aripiprazole	308 (2)	⊕⊕⊕⊝ Moderate^a	‐
Weight gain 8 weeks of treatment	MD 1.13 (0.71 to 1.54) points relative to placebo	308 (2)	⊕⊕⊕⊝ Moderate^a	‐
Sedation 8 weeks of treatment	RR 4.28 (1.58 to 11.60)	313 (2)	⊕⊕⊕⊝ Moderate^a	‐
Tremor 8 weeks of treatment	RR 10.26 (1.37 to 76.63)	313 (2)	⊕⊕⊕⊝ Moderate^a	‐
Relapse rate 16 weeks of treatment	HR 0.57 (0.28 to 1.12)	85 (1)	Low^b	‐
ABC: Aberrant Behavior Checklist; GRADE: Grades of Recommendation, Assessment, Development and Evaluation; HR: hazard ratio;MD: mean difference; RR: risk ratio
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
^aQuality was rated as moderate because of unclear risk of bias for some domains in Marcus 2009 and Owen 2009, and because of the overall small number of studies conducted using aripiprazole in ASD. ^bQuality of evidence for long‐term trials was rated as low because of high risk of attrition bias for incomplete outcome data in Findling 2014. Further research may have an important impact on our confidence in the estimate of effect and may change the estimate. *A small number of studies have evaluated the use of aripiprazole for ASD. Only one study examined aripiprazole at a duration longer than eight weeks. Future trials of aripiprazole in children/adolescents with ASD are likely to impact the estimates found in this review.

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Comparison 1. Aripiprazole versus placebo in randomised controlled trials (RCTs)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Aberrant Behavior Checklist (ABC) ‐ Irritability subscale: mean score changes Show forest plot	2	308	Mean Difference (IV, Random, 95% CI)	‐6.17 [‐9.07, ‐3.26]

2 Aberrant Behavior Checklist (ABC) ‐ Hyperactivity subscale: mean score changes Show forest plot	2	308	Mean Difference (IV, Random, 95% CI)	‐7.93 [‐10.98, ‐4.88]

3 Aberrant Behavior Checklist (ABC) ‐ Stereotypy subscale: mean score changes Show forest plot	2	308	Mean Difference (IV, Random, 95% CI)	‐2.66 [‐3.55, ‐1.77]

4 Aberrant Behavior Checklist (ABC) ‐ Inappropriate Speech subscale: mean score changes Show forest plot	2	308	Mean Difference (IV, Random, 95% CI)	‐1.43 [‐2.60, ‐0.27]

5 Aberrant Behavior Checklist (ABC) ‐ Lethargy/Withdrawal subscale: mean score changes Show forest plot	2	308	Mean Difference (IV, Random, 95% CI)	‐1.19 [‐2.77, 0.40]

6 Clinical Global Impression (CGI) ‐ Severity subscale: mean scores Show forest plot	2	308	Mean Difference (IV, Random, 95% CI)	‐0.57 [‐0.96, ‐0.18]

7 Clinical Global Impression (CGI) ‐ Improvement subscale: mean scores Show forest plot	2	308	Mean Difference (IV, Random, 95% CI)	‐1.33 [‐1.75, ‐0.92]

8 Any extrapyramidal symptom event (side effect) Show forest plot	2	313	Risk Ratio (M‐H, Random, 95% CI)	1.89 [0.98, 3.66]

9 Children's Yale‐Brown Obsessive Compulsive Scale (CY‐BOCS): mean scores Show forest plot	2	308	Mean Difference (IV, Random, 95% CI)	‐1.93 [‐3.86, 0.00]

10 Clinically relevant weight gain (side effect) Show forest plot	2	308	Risk Ratio (M‐H, Random, 95% CI)	3.78 [1.78, 8.02]

11 Weight gain (side effect) Show forest plot	2	308	Mean Difference (IV, Random, 95% CI)	1.13 [0.71, 1.54]

12 Body mass index (BMI) change from baseline (side effect) Show forest plot	2	313	Mean Difference (IV, Random, 95% CI)	0.44 [‐0.27, 1.16]

13 Elevated fasting triglycerides at endpoint (side effect) Show forest plot	2	313	Risk Ratio (M‐H, Random, 95% CI)	1.51 [0.62, 3.67]

14 Elevated low‐density lipoprotein at endpoint (side effect) Show forest plot	2	313	Risk Ratio (M‐H, Random, 95% CI)	3.19 [0.13, 76.36]

15 Decreased high‐density lipoprotein at endpoint (side effect) Show forest plot	2	313	Risk Ratio (M‐H, Random, 95% CI)	0.94 [0.11, 8.18]

16 Elevated fasting blood glucose at endpoint (side effect) Show forest plot	2	313	Risk Ratio (M‐H, Random, 95% CI)	1.57 [0.08, 32.11]

17 Sedation (side effect) Show forest plot	2	313	Risk Ratio (M‐H, Random, 95% CI)	4.28 [1.58, 11.60]

18 Drooling (side effect) Show forest plot	2	313	Risk Ratio (M‐H, Random, 95% CI)	9.64 [1.29, 72.10]

19 Tremor (side effect) Show forest plot	2	313	Risk Ratio (M‐H, Random, 95% CI)	10.26 [1.37, 76.63]

Comparison 1. Aripiprazole versus placebo in randomised controlled trials (RCTs)

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