Among 13 patients who completed six months of treatment with sertraline, the researchers reported a greater than 90% decrease in the frequency of temper outbursts.
Treatment over six months also led to lower body mass index, a measure of body fat, the study found.
Titled “Sertraline as a treatment option for temper outbursts in Prader–Willi syndrome,” the study was published in the American Journal of Medical Genetics.
People with PWS frequently have severe temper outbursts, which have been reported to affect 88% of patients. While general behavioral problems in those with PWS start in childhood, temper outbursts specifically seem to increase with age, and contribute to a poorer quality of life for both patients and caregivers. Often, such outbursts are combined with physical aggressiveness and self‐injury, the researchers noted.
There currently are no treatment guidelines for temper outbursts in PWS patients. One of the possible therapeutic approaches, besides certain antipsychotics, is the use of antidepressants such as selective serotonin reuptake inhibitors (SSRIs). These work by increasing brain levels of the chemical messenger serotonin, which helps regulate mood, besides other functions.
However, evidence of the effectiveness of SSRIs in PWS is limited to case reports, lacking evidence from large studies.
Here, a group of researchers at the Medical School Hannover, in Germany, reviewed data from 14 people with a confirmed genetic diagnosis of PWS. The patients comprised six females and eight males, with a mean age of 31, ranging in age from 16 to 51.
All had sought counseling due to their severe and frequent temper outbursts, which were accompanied by physical aggressiveness and, in certain cases, by self-injuries. Two had a prior diagnosis of autism spectrum disease. No other mental disorders were diagnosed among the remaining participants.
The patients initially were treated with 25 mg of the SSRI sertraline per day, with that dose increasing if no improvements were seen after a minimum of four weeks (about one month). The Clinical Global Impression Severity of Illness Scale (CGIS), a seven-point tool in which a score of one is normal and seven means severely ill, was used at the study’s start (baseline). The Global Improvement Scale was used to assess treatment outcomes following six months of sertraline, using information given by both patients and caregivers.
At baseline, one participant was categorized as “moderately ill,” with a score of four, while four people had a score of 5, noted as “markedly ill.” Eight of the patients were categorized as “severely ill,” with a score of six, and one as “among the most extremely ill patients” with a score of seven.
After six months, 13 patients (92.6%) had a significant reduction in the frequency of temper outbursts, with no reports of property destruction or of attacks on other persons. A treatment response was defined as a score of one — “very much improved” — or two for “much improved.”
Among the respondents, six received sertraline at a dose of 25 mg/day, eight at 50 mg/day, and one a daily dose of 75 mg. One patient showed no response to treatment with 100 mg/day.
In one case, treatment was discontinued due to severe sleep abnormalities, which enhanced behavioral problems. After six months, one participant reported occasional vertigo, but its frequency was not considered severe; thus, treatment was maintained. Routine blood analyses of all participants showed no abnormalities.
Seven patients were not being treated with any antipsychotics at the start of the study. The remaining participants received risperidone (sold under the brand name Risperdal among others), aripiprazole (marketed as Abilify, for example), and two the anticonvulsant oxcarbazepine.
Three patients stopped treatment with these therapies due to improvements with sertraline, and in one case the dose of risperidone was lowered.
In addition, the patients’ body mass index dropped by an average of 1.5 kg per square meters over the six months, indicative of “a positive effect of sertraline on weight in patients with PWS,” the researchers wrote.
Overall, “sertraline is a promising and safe treatment option for severe temper outbursts in patients with PWS,” they concluded.
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