An Antipsychotic May Ease Temper Outbursts in PWS, Small Study Suggests

Half of people with Prader-Willi syndrome (PWS) treated with the antipsychotic aripiprazole in a small German study experienced fewer temper outbursts, but daytime sleepiness was a common side effect.

The medication did not cause an increase in weight, however, which is a plus considering that people with PWS typically have an increased appetite and eat excessively.

The findings suggest that aripiprazole may be “a treatment option for temper outbursts in people with PWS,” the researchers wrote.

The study, “Aripiprazole treatment for temper outbursts in Prader-Willi syndrome,” was published in the Orphanet Journal of Rare Diseases.

PWS is a genetic disease that can cause a wide range of symptoms, including learning difficulties, developmental delays, problems with sleep, a short stature, and an increased appetite and overeating that may lead to weight gain and obesity. It also can cause behavioral challenges, including temper outbursts, acting out physically, and shouting, screaming, and crying.

Aripiprazole, sold as Abilify and Aristada among other names, is an antipsychotic that is typically used for the treatment of schizophrenia, temper tantrums, and other psychiatric symptoms.

It has been used off-label in patients with PWS for behavioral challenges, a type of symptom for which “reliable treatment recommendations are currently not available,” the researchers wrote. Moreover, the few existing reports sometimes contradict one another, with a research study showing that aripiprazole actually worsened aggressiveness, irritability, and impulsiveness in patients ages 11–19.

The present study included 10 patients (six men and four women) with a genetic diagnosis of PWS. Their mean age was 35.8 years, ranging from 25 to 52 years. Seven of the adults had never taken any medication to control behavior or mood; two were on antipsychotic and antidepressant treatment, and one was taking an antidepressant.

All reached out to their doctors to treat temper outbursts, which they described as “irritability in general and tantrums during conflicts or disagreements.” Depending on the Clinical Global Impression (CGI) scale score, the temper outbursts could be accompanied by damage to things or harm to others.

To understand how severe the symptoms were, the doctors used the Clinical Global Impression-Severity (CGI-S) scale. Two of the patients scored five points in the CGI-S scale, meaning they had temper outbursts more than twice a month and/or damaged things severely but did not harm others. Seven other patients had a score of six points, which means they had multiple temper outbursts per month and/or damaged things severely or harmed others in a nonserious way. One patient scored a seven, meaning she had multiple temper outbursts per month and/or damaged things or harmed others severely.

Daily treatment with aripiprazole eased the symptoms of seven patients. Of these participants, five took aripiprazole at 5 mg per day and two took the higher 10 mg dose.

To understand the extent of improvement, the team used the CGI-Improvement scale. Three patients were found to have “very much improved,” and four were found to have “much improved” conditions. Of these seven patients, two stopped taking aripiprazole due to daytime sleepiness. Among the remaining three patients, two experienced only minimal improvement, and one saw no changes in temper outbursts.

Overall, this means that five, or half of the patients, “were successfully treated with aripiprazole for temper outbursts,” the researchers wrote.

Two participants who experienced improvements were either already taking or started taking sertraline, an antidepressant.

Daytime sleepiness, a known side effect of aripiprazole, occurred in six patients. In two of them, daytime sleepiness was mild, and there was no need to change the medication. In the other four patients, the medication was switched to the evening. In two, that reduced daytime sleepiness; in the other two, the medication was stopped due to the severity of daytime sleepiness.

In seven patients who underwent treatment for six months, body mass index (a measure of body fat) was measured before the start and at the end of treatment. No remarkable changes were observed (23.76 vs. 23.49 kilograms per square meter).

The findings suggest that not only “aripiprazole can lead to a reduction of symptoms,” but also “the absence of weight gain makes aripiprazole interesting especially for the PWS population,” the researchers concluded.