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Aripiprazole and Autism Ranking: Mildly Hazardous Very strong positive evidence

Current Research

Description of the studies

We have identified 23* studies of aripiprazole as a treatment for people on the autism spectrum in peer-reviewed journals published in English.

These studies included more than 800 individuals on the autism spectrum aged from 4 years old to adult, although the bulk of studies were of children and young people.  Individuals with specific diagnoses included people with autistic disorder, Asperger syndrome or pervasive developmental disorder - not otherwise specified.  A small number of studies also included people with other conditions, such as bipolar disorder or Fragile X syndrome.

The length of treatment varied between eight weeks and two and a half years, although in most cases the treatment lasted eight,12 or 24 weeks. The dosage of aripiprazole varied from 0.5 mg to 30 mg per day, although in most case the dosage was in the region of 5mg, 10mg or 15 mg per day. Younger children received smaller doses than adolescents and adults. In most cases, the medication was started at a low dose and gradually increased to a higher maximum dose. 

Seven of the studies used a group design, usually comparing a group of people receiving aripiprazole to a different group receiving a placebo. 16 of the studies used single case designs, usually in the form of an open trial of aripiprazole within a single group. A minority of the group studies compared aripiprazole with other antipsychotics, such as risperidone. 

Seven of the papers reported data from the same two studies (Marcus et al, 2009 and Owen et al, 2009). For example, the paper by Robb et al (2011) provided information on the safety and tolerability of aripiprazole pooled from these two studies.

Two of the papers reported on the same study which compared antipsychotics combined with a parent training programme against antipsychotics alone. The bulk of participants who received an antipsychotic received risperidone rather than aripiprazole.

*Please note: we have not included studies with fewer than three autistic participants.

Outcomes of the studies

Most of the studies (such as Marcus et al, 2009 and Owen et al, 2009) reported reduced irritability (which includes tantrums, aggression, self-injurious behaviour, or a combination of these symptoms).

Two of the studies (Marcus et al, 2009 and Owen et al, 2009) also reported improvements in the quality of life of the participants and of their family members.

A number of studies reported improvements in other areas. For example

  • One study (Fung et al, 2012) reported that aripiprazole improved 'auditory processing, and modulation of visual input affecting emotional responses and activity level, suggesting that aripiprazole might be beneficial in targeting sensory abnormalities in autism.’
  • One study (Huang, Tsai and Yang, 2010) reported that aripiprazole “significantly improved the social interaction of ... three children. Furthermore, two patients also showed significant improvement in depression/anxiety syndromes.”

A minority of studies reported mixed findings. For example 

  • Findling et al (2014) reported “In this study, there was no statistically significant difference between aripiprazole and placebo in time to relapse during maintenance therapy. However, the [hazard ratio] and [number needed to treat] suggest some patients will benefit from maintenance treatment.”  
  • Rugino and Janvier Y (2005) reported “Only 4 of 16 bipolar and autistic subjects (25%) demonstrated reduced aggression without adverse events...  Coadministration of sedative medications (particularly guanfacine or clonidine) and weight < 58 kg increased the risk of adverse events, such as increased lability and aggression.”

Some of the studies reported adverse effects. For example, 

  • Marcus et al (2011) reported “Adverse events were experienced by 286/330 subjects (86.7%). Common adverse events included weight increase, vomiting, nasopharyngitis, increased appetite, pyrexia, upper respiratory tract infection, and insomnia.”

Some of the studies (such as Ishitobi et al, 2012) reported that aripiprazole was well tolerated by some participants and might constitute an alternative treatment for subjects on the autism spectrum who experience tolerability issues with risperidone.  

Updated
17 Jun 2022
Last Review
01 Jul 2018
Next Review
01 Mar 2024