Aripiprazole and Autism Ranking:

There are a number of limitations to all of the research studies published to date. For example

Most of the studies (such as Jordan et al, 2012) used single-case designs, that is, they did not have a control group of participants who did not receive aripiprazole.
Most of the single case design studies used relatively weak methodologies. For example, Fung et al (2012) used a non-experimental, retrospective chart review.
One of the group studies (Lamberti et al, 2016) was a controlled study but it was non-randomised and non-blinded.
Some of the studies did not follow (or provide information about) all of the protocols expected within that type of study. For example, the randomised controlled trial by Marcus et al (2009) did not adequately describe the blinding process.

Some of the studies (such as Huang,Tsai and Yang, 2010) included fewer than 10 participants.
Some of the studies had a very high dropout rate. For example, in the study by Marcus et al (2011), only 199 of 330 participants (60.3%) completed 52 weeks of treatment.
Some of the studies were restricted to specific groups of participants. For example, Findling et al (2014) looked only at children and young people diagnosed with autistic disorder.
Some of the studies examined participants with a range of conditions, only some of whom were on the autism spectrum. For example, Valicenti-McDermott and Demb (2006) studied 32 participants with developmental disorders 24 of whom were on the autism spectrum.
Some of the studies (such as Rugino and Janvier, 2005) did not independently verify the diagnosis of autism using established diagnostic tools like the ADOS or ADI-R.

Some of the studies gave very little detail about the aripiprazole and how it was administered. For example, Gibson et al (2007) did not state the length of treatment, the frequency of treatment or the dosage of aripiprazole that was given to the participants.
Two of the papers (Aman et al, 2009 and Scahill et al, 2012) reported on the same study which compared antipsychotics combined with a parent training programme against antipsychotics alone. However the bulk of participants who received an antipsychotic in this study received risperidone rather than aripiprazole.
Some of the studies (such as Rugino and Janvier, 2005) examined participants who received one or more other medications at the same time as they received aripiprazole.
Some of the studies (such as Ichikawa et al, 2017) ran for relatively short periods of time (eight weeks).

Some of the studies used a small number of outcome measures and/or used less robust outcome measures. For example, Basgul (2014) used only one outcome measure, the Clinical Global Impression Scale. This is less robust than some other measures because it relies on the subjective judgement of the clinician.
Some of the studies did not break down outcome data by specific groups of participants. For example, Erickson et al, 2011 examined 12 participants with Fragile X syndrome but did not provide separate outcome data for the 10 participants who were also on the autism spectrum.
Some of the studies (such as Huang et al, 2010) did not provide any kind of statistical analysis of the outcomes.
Some of the studies (such as Jordan et al, 2012) did not report objective measures of potential adverse side effects (such as changes to blood glucose levels etc.).
Most of the studies did not identify if aripiprazole had any beneficial effects in the medium to long term (six months or longer).

Most of the studies did not appear to involve people on the autism spectrum or parents and carers in the design, development and evaluation of those studies.
Some of the studies (such as Marcus et al, 2009 and Owen et al, 2009) were funded by Otsuka and/or Bristol-Myers Squibb, the manufacturer and suppliers of aripiprazole. The researchers involved may therefore have been biased towards the intervention, however unconsciously.

For a comprehensive list of potential flaws in research studies, please see ‘Why some autism research studies are flawed’.

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