Dataset Information

Asenapine in the Treatment of Bipolar Depression.

ABSTRACT:

Objectives

Asenapine, a potent serotonin 7 (5-HT₇) receptor antagonist, was examined for efficacy as an antidepressant in depressed bipolar subjects. It was predicted that subjects with the genetic variant of the short form of the serotonin transporter (5HTTR) would be more likely to respond.

Experimental design

A subset of patients participating in a randomized, placebo-controlled study of the efficacy of asenapine in bipolar I depression also underwent genetic testing for the 5HTTR. Montgomery Åsberg Depression Rating Scale (MADRS) score was ? 26 prior to randomization to asenapine or placebo for 8 weeks. Gene testing was performed before breaking the blind.

Principal observations

Nine patients completing the study also underwent gene testing. At study end, the average MADRS improvement was -19.80 ± SD 8.59 for the 4 people randomized to asenapine and -3.80 ± 9.01 for the 5 people receiving placebo (P = 0.021, t = 2.88). Anxiety, as measured by the Hamilton Anxiety Rating Scale (HAM-A), also improved in asenapine-treated patients (-15.40 ± 6.15 vs. -2.80 ± 7.95, P = 0.023, t = 2.803). Six participants had the short form of the 5HTTR, and it is believed they influenced the significant outcome in this small sample.

Conclusions

While this is a very small sample, asenapine appears to have a beneficial effect on both depression and anxiety in depressed bipolar I patients compared to treatment with placebo. Due to the large fraction of subjects with the short form, the hypothesis that the SF-5HTTR might increase asenapine response could not be adequately tested.

SUBMITTER: El-Mallakh RS

PROVIDER: S-EPMC7093720 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Asenapine in the Treatment of Bipolar Depression.

El-Mallakh Rif S RS Nuss Sharon S Gao Dong D Gao Yonglin Y Ahmad Surriya Colleen SC Schrodt Clare C Adler Caleb C

Psychopharmacology bulletin 20200301 1

<h4>Objectives</h4>Asenapine, a potent serotonin 7 (5-HT<sub>7</sub>) receptor antagonist, was examined for efficacy as an antidepressant in depressed bipolar subjects. It was predicted that subjects with the genetic variant of the short form of the serotonin transporter (5HTTR) would be more likely to respond.<h4>Experimental design</h4>A subset of patients participating in a randomized, placebo-controlled study of the efficacy of asenapine in bipolar I depression also underwent genetic testing ...[more]

PMID: 32214517

Similar Datasets

Project description:Asenapine (Saphris(®)) is an atypical antipsychotic drug which has been approved by the US Food and Drug Administration for the treatment of schizophrenia in adults, as well as the treatment of acute manic or mixed episodes of bipolar I in both adult and pediatric populations. Asenapine is a tetracyclic drug with antidopaminergic and antiserotonergic activity with a unique sublingual route of administration. In this review, we examine and summarize the available literature on the safety, efficacy, and tolerability of asenapine in the treatment of bipolar disorder (BD). Data from randomized, double-blind trials comparing asenapine to placebo or olanzapine in the treatment of acute manic or mixed episodes showed asenapine to be an effective monotherapy treatment in clinical settings; asenapine outperformed placebo and showed noninferior performance to olanzapine based on improvement in the Young Mania Rating Scale scores. There are limited data available on the use of asenapine in the treatment of depressive symptoms of BD, or in the maintenance phase of BD. The available data are inconclusive, suggesting the need for more robust data from prospective trials in these clinical domains. The most commonly reported adverse effect associated with use of asenapine is somnolence. However, the somnolence associated with asenapine use did not cause significant rates of discontinuation. While asenapine was associated with weight gain when compared to placebo, it appeared to be modest when compared to other atypical antipsychotics, and its propensity to cause increases in hemoglobin A1c or serum lipid levels appeared to be similarly modest. Asenapine does not appear to cause any clinically significant QTc prolongation. The most commonly reported extra-pyramidal symptom associated with asenapine was akathisia. Overall, asenapine appears to be a relatively well-tolerated atypical antipsychotic, effective in the treatment of acute manic and mixed episodes of BD.

Dataset Information

Asenapine in the Treatment of Bipolar Depression.

Objectives

Experimental design

Principal observations

Conclusions

Publications

Asenapine in the Treatment of Bipolar Depression.

Similar Datasets

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