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Meta-Analysis
. 2016 Jun 26;2016(6):CD009043.
doi: 10.1002/14651858.CD009043.pub3.

Aripiprazole for autism spectrum disorders (ASD)

Lauren E Hirsch  1 , Tamara Pringsheim
Affiliations
Meta-Analysis

Aripiprazole for autism spectrum disorders (ASD)

Lauren E Hirsch et al. Cochrane Database Syst Rev. .

Abstract

Background: Autism spectrum disorders (ASD) include autistic disorder, Asperger's disorder and pervasive developmental disorder - not otherwise specified (PDD-NOS). Antipsychotics have been used as a medication intervention for irritability related to ASD. Aripiprazole, a third-generation, atypical antipsychotic, is a relatively new drug that has a unique mechanism of action different from that of other antipsychotics. This review updates a previous Cochrane review on the safety and efficacy of aripiprazole for individuals with ASD, published in 2011 (Ching 2011).

Objectives: To assess the safety and efficacy of aripiprazole as medication treatment for individuals with ASD.

Search methods: In October 2015, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and seven other databases as well as two trial registers. We searched for records published in 1990 or later, as this was the year aripiprazole became available.

Selection criteria: Randomised controlled trials (RCTs) of aripiprazole (administered orally and at any dosage) versus placebo for treatment of individuals with a diagnosis of ASD.

Data collection and analysis: Two review authors independently collected, evaluated and analysed data. We performed meta-analysis for primary and secondary outcomes, when possible. We used the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach to rate the overall quality of the evidence.

Main results: We included three trials in this review. Two were included in the previous published review, and the results of one, placebo-controlled discontinuation study were added to this review. Although we searched for studies across age groups, we found only studies conducted in children and youth. Included trials had low risk of bias across most domains. High risk of bias was seen in only one trial with incomplete outcome data. We judged the overall quality of the evidence for most outcomes to be moderate.Two RCTs with similar methods evaluated use of aripiprazole for a duration of eight weeks in 316 children/adolescents with ASD. Meta-analysis of study results revealed a mean improvement of -6.17 points on the Aberrant Behavior Checklist (ABC) - Irritability subscale (95% confidence intervals (CIs) -9.07 to -3.26, two studies, 308 children/adolescents, moderate-quality evidence), -7.93 points on the ABC - Hyperactivity subscale (95% CI -10.98 to -4.88, two studies, 308 children/adolescents, moderate-quality evidence) and -2.66 points on the ABC - Stereotypy subscale (95% CI -3.55 to -1.77, two studies, 308 children/adolescents, moderate-quality evidence) in children/adolescents taking aripiprazole relative to children/adolescents taking placebo. In terms of side effects, children/adolescents taking aripiprazole had a greater increase in weight, with a mean increase of 1.13 kg relative to placebo (95% CI 0.71 to 1.54, two studies, 308 children/adolescents, moderate-quality evidence), and had a higher risk ratio (RR) for sedation (RR 4.28, 95% CI 1.58 to 11.60, two studies, 313 children/adolescents, moderate-quality evidence) and tremor (RR 10.26, 95% CI 1.37 to 76.63, two studies, 313 children/adolescents, moderate-quality evidence). A randomised, placebo-controlled discontinuation study found that 35% of children/adolescents randomised to continue intervention with aripiprazole relapsed with respect to their symptoms of irritability, compared with 52% of children/adolescents randomised to placebo, for a hazard ratio of 0.57 (95% CI 0.28 to 1.12, 85 children/adolescents, low-quality evidence).All three included trials were supported by Bristol-Myers Squibb (Princeton, NJ) and Otsuka Pharmaceutical Company, Ltd. (Tokyo, Japan), with editorial support provided by Ogilvy Healthworld Medical Education and Bristol-Myers Squibb.

Authors' conclusions: Evidence from two RCTs suggests that aripiprazole can be effective as a short-term medication intervention for some behavioural aspects of ASD in children/adolescents. After a short-term medication intervention with aripiprazole, children/adolescents showed less irritability and hyperactivity and fewer stereotypies (repetitive, purposeless actions). However, notable side effects, such as weight gain, sedation, drooling and tremor, must be considered. One long-term, placebo discontinuation study found that relapse rates did not differ between children/adolescents randomised to continue aripiprazole versus children/adolescents randomised to receive placebo, suggesting that re-evaluation of aripiprazole use after a period of stabilisation in irritability symptoms is warranted. Studies included in this review used criteria from the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (APA 2000) for ASD diagnosis; however, the diagnostic criteria for ASD changed significantly with release of the fifth edition of the DSM (DSM-5) in 2013 (APA 2013).

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Conflict of interest statement

Lauren Hirsch has no conflicts of interest to declare.

Tamara Pringsheim (TP) has received direct financial gain from:

  1. Teva Canada Innovation, on one occasion in 2014, for consulting. TP declares that Teva does not make or market any products relevant to this review.

TP has received indirect financial gain from:

  1. Shire Canada, in 2015. TP received an unrestricted educational grant to create an educational curriculum on assessment and treatment of aggression in youth. TP declares that Shire does not make or market any products relevant to this review.

TP declares that the entities listed below are funding agencies that do not make treatments for ASD or any other disease.

  1. Canadian Institutes of Health Research, for research funding to create a patient decision aid in 2014 and 2015.

  2. Alberta Mental Health Strategic Clinical Network, for research funding on off‐label prescribing of antipsychotics in 2015.

  3. Mathison Centre for Mental Health Research and Education, for research funding for the Canadian Schizophrenia Guidelines in 2015.

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
1.1
1.1. Analysis
Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 1 Aberrant Behavior Checklist (ABC) ‐ Irritability subscale: mean score changes.
1.2
1.2. Analysis
Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 2 Aberrant Behavior Checklist (ABC) ‐ Hyperactivity subscale: mean score changes.
1.3
1.3. Analysis
Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 3 Aberrant Behavior Checklist (ABC) ‐ Stereotypy subscale: mean score changes.
1.4
1.4. Analysis
Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 4 Aberrant Behavior Checklist (ABC) ‐ Inappropriate Speech subscale: mean score changes.
1.5
1.5. Analysis
Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 5 Aberrant Behavior Checklist (ABC) ‐ Lethargy/Withdrawal subscale: mean score changes.
1.6
1.6. Analysis
Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 6 Clinical Global Impression (CGI) ‐ Severity subscale: mean scores.
1.7
1.7. Analysis
Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 7 Clinical Global Impression (CGI) ‐ Improvement subscale: mean scores.
1.8
1.8. Analysis
Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 8 Any extrapyramidal symptom event (side effect).
1.9
1.9. Analysis
Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 9 Children's Yale‐Brown Obsessive Compulsive Scale (CY‐BOCS): mean scores.
1.10
1.10. Analysis
Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 10 Clinically relevant weight gain (side effect).
1.11
1.11. Analysis
Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 11 Weight gain (side effect).
1.12
1.12. Analysis
Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 12 Body mass index (BMI) change from baseline (side effect).
1.13
1.13. Analysis
Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 13 Elevated fasting triglycerides at endpoint (side effect).
1.14
1.14. Analysis
Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 14 Elevated low‐density lipoprotein at endpoint (side effect).
1.15
1.15. Analysis
Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 15 Decreased high‐density lipoprotein at endpoint (side effect).
1.16
1.16. Analysis
Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 16 Elevated fasting blood glucose at endpoint (side effect).
1.17
1.17. Analysis
Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 17 Sedation (side effect).
1.18
1.18. Analysis
Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 18 Drooling (side effect).
1.19
1.19. Analysis
Comparison 1 Aripiprazole versus placebo in randomised controlled trials (RCTs), Outcome 19 Tremor (side effect).
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