Asenapine for the Acute Treatment of Pediatric Manic or Mixed Episode of Bipolar I Disorder

Asenapine, brand name Saphris, is a sublingual tablet that is FDA labeled for the treatment of bipolar disorder and schizophrenia. Like most antipsychotics, the exact mechanism of action is unknown, just that it acts on dopamine receptors in the brain. Findling and colleagues preformed a double-blind placebo controlled study in which they studied the use of asenapine for the treatment of manic or mixed episode bipolar disorders in children aged 10 to 17 years old. The doses included placebo 2.5 mg, 5 mg, and 10 mg twice daily and they were distributed to the patients in a 1:1:1:1 ratio. 403 patients were included in the study, so about 101 patients received each dose. The results were measured based on the Young-mania rating scale (YMRS). The YMRS is a rating scale based on the patient’s subjective view of his or her manic symptoms in the last 48 hours. The YMRS was assessed after 21 days of the assigned medication strength.

The average YMRS rating is 12 and the results showed that after the 21 days the average difference in YMRS for those with the placebo controlled versus the asenapine doses were -3.2 for the 2.5 mg, -5.3 for the 5.0 mg, and -6.2 for the 10 mg. In contrast to the average improvement in the YMRS, there was significantly more adverse effects experienced by those taking the asenapine doses. These adverse effects include somnolence, sedation, increased appetite, weight gain, and increased fasting blood glucose levels. The researchers also looked at the presence of ADHD and if the symptoms were changed, which they were not.

The researchers concluded that asenapine is superior to the placebo with the improvement of YMRS scores and was very well tolerated, even with the increase in side effects.

This is really interesting, and relevant to our learning in top drugs currently. This is not one of the antipsychotics we are learning about specifically, but its really interesting to see actual data for the use of an antipsychotic, especially on kids. I wonder if there have been studies done that look to see if antipsychotics affect the brain development of these children as they grow.

J AM ACAD CHILD ADOLESC PSYCHIATRY. 2015;45(12):1032-1041.