Asenapine, an antipsychotic medicine, is used to treat mania in bipolar disorder. Researchers looked to see if it was helpful for people with bipolar disorder who had mixed episodes.
Results showed that asenapine lowered symptoms of both mania and depression over the 12 weeks of the study.
Antipsychotic medicines can have side effects, so long-term studies are needed.
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Researchers, led by J.M. Azorin at the Hospital Ste. Marguerite in Marseille, France, compiled the information from two clinical trials of asenapine, which is sold under the names Saphris and Sycrest by Merck.
Asenapine is an antipsychotic that is approved to treat schizophrenia and bipolar mania.
For their study, the researchers looked at people who were experiencing mixed episodes. Mixed episodes may include symptoms of mania, like feeling hyper or needing less sleep. But they may also include depressive symptoms at the same time, like feeling sad or having changes in appetite.
A total 295 patients in the two trials had mixed episodes. For the first three weeks of the trials, patients took either Zyprexa (olanzapine, an antipsychotic), asenapine or sugar pill. Then, 102 of the patients continued on either olanzapine or asenapine for nine more weeks.
The researchers used standard tests for symptoms of both depression and mania. Each participant had a score for their depression symptoms and another score for mania symptoms.
After three weeks, patients who took asenapine had lower scores for both depression and mania symptoms compared to those taking the sugar pills.
After 12 weeks, asenapine lowered scores even more on both symptom tests. The people who continued on olanzapine showed a similar level of improvement in symptoms.
The authors concluded that asenapine helped lower symptoms for people with mixed episodes, and it worked about as well as olanzapine.
Side effects of antipsychotics can be more severe than those seen in other types of bipolar disorder medications, like mood stabilizers. In this study, about 84 percent of people taking asenapine reported side effects. Side effects were also reported by about 70 percent of people taking sugar pill and about 74 percent of people taking olanzapine.
Increased appetite, changes in sleep, sedation and dizziness were the most common side effects reported by people taking asenapine. Participants taking olanzapine reported similar side effects.
The authors said, “To conclude, these exploratory post hoc analyses provide supportive evidence for the efficacy of asenapine in treating the associated symptoms of mania as well as core features of depression in bipolar I patients with mixed episodes. Further prospective studies in this specific population are warranted to confirm these preliminary findings.”
The study was limited by the fact that it looked at people with mixed episodes who were part of another trial. Trials aimed specifically at people with mixed episodes are needed.
dailyRx News spoke with psychiatrist Barbara Long, MD, PhD, about the results of this trial. She said, “There are a number of limitations of this study in addition to the one cited. First, there are known drawbacks to the use of antipsychotic medications in bipolar mixed episodes, including the risk of some potentially permanent side effects, such as tardive dyskinesia, a movement disorder, or neuroleptic malignant syndrome, which is a rare but fatal complication. Such risks are accepted when the antipsychotic is used to treat schizophrenia and other psychotic disorders, but usually treaters prefer to use mood stabilizers to treat bipolar disorder, as these carry fewer risks of major side effects.
“Second, data is absent about the safety and efficacy of asenapine used beyond the acute phase of stabilization, whereas other medications (antipsychotic and mood stabilizers) with longer track records are better understood. The conclusion is that these results are of interest but should be only considered preliminary. Treaters should carefully weigh the potential risks versus benefits of using an antipsychotic to treat bipolar disorder versus mood stabilizers, which carry fewer risks.”
This study was published in the February issue of the Journal of Affective Disorders. The original studies were funded by Merck. This post hoc analysis was funded by Lundbeck. The authors reported affiliations with multiple pharmaceutical companies.