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Asenapine in the Treatment of Bipolar Depression.
Psychopharmacol Bull. 2020 Mar 12; 50(1):8-18.PB

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.

Authors+Show Affiliations

El-Mallakh, MD, Nuss, MS, D. Gao, MD, Y. Gao MD, Surriya Ahmad, MD, Schrodt, BS, Mood Disorders Research Program, Department of Psychiatry and Behavioral Sciences, University of Louisville School of Medicine, Louisville, Kentucky. D. Gao, MD, Post Doctoral Fellow at University of Louisville, Current Address: College of Integrative Medicine Fujian University of Traditional Chinese Medicine Fuzhou, Fujian, China. Adler, MD, Department of Psychiatry University of Cincinnati Cincinnati, Ohio.El-Mallakh, MD, Nuss, MS, D. Gao, MD, Y. Gao MD, Surriya Ahmad, MD, Schrodt, BS, Mood Disorders Research Program, Department of Psychiatry and Behavioral Sciences, University of Louisville School of Medicine, Louisville, Kentucky. D. Gao, MD, Post Doctoral Fellow at University of Louisville, Current Address: College of Integrative Medicine Fujian University of Traditional Chinese Medicine Fuzhou, Fujian, China. Adler, MD, Department of Psychiatry University of Cincinnati Cincinnati, Ohio.El-Mallakh, MD, Nuss, MS, D. Gao, MD, Y. Gao MD, Surriya Ahmad, MD, Schrodt, BS, Mood Disorders Research Program, Department of Psychiatry and Behavioral Sciences, University of Louisville School of Medicine, Louisville, Kentucky. D. Gao, MD, Post Doctoral Fellow at University of Louisville, Current Address: College of Integrative Medicine Fujian University of Traditional Chinese Medicine Fuzhou, Fujian, China. Adler, MD, Department of Psychiatry University of Cincinnati Cincinnati, Ohio.El-Mallakh, MD, Nuss, MS, D. Gao, MD, Y. Gao MD, Surriya Ahmad, MD, Schrodt, BS, Mood Disorders Research Program, Department of Psychiatry and Behavioral Sciences, University of Louisville School of Medicine, Louisville, Kentucky. D. Gao, MD, Post Doctoral Fellow at University of Louisville, Current Address: College of Integrative Medicine Fujian University of Traditional Chinese Medicine Fuzhou, Fujian, China. Adler, MD, Department of Psychiatry University of Cincinnati Cincinnati, Ohio.El-Mallakh, MD, Nuss, MS, D. Gao, MD, Y. Gao MD, Surriya Ahmad, MD, Schrodt, BS, Mood Disorders Research Program, Department of Psychiatry and Behavioral Sciences, University of Louisville School of Medicine, Louisville, Kentucky. D. Gao, MD, Post Doctoral Fellow at University of Louisville, Current Address: College of Integrative Medicine Fujian University of Traditional Chinese Medicine Fuzhou, Fujian, China. Adler, MD, Department of Psychiatry University of Cincinnati Cincinnati, Ohio.El-Mallakh, MD, Nuss, MS, D. Gao, MD, Y. Gao MD, Surriya Ahmad, MD, Schrodt, BS, Mood Disorders Research Program, Department of Psychiatry and Behavioral Sciences, University of Louisville School of Medicine, Louisville, Kentucky. D. Gao, MD, Post Doctoral Fellow at University of Louisville, Current Address: College of Integrative Medicine Fujian University of Traditional Chinese Medicine Fuzhou, Fujian, China. Adler, MD, Department of Psychiatry University of Cincinnati Cincinnati, Ohio.El-Mallakh, MD, Nuss, MS, D. Gao, MD, Y. Gao MD, Surriya Ahmad, MD, Schrodt, BS, Mood Disorders Research Program, Department of Psychiatry and Behavioral Sciences, University of Louisville School of Medicine, Louisville, Kentucky. D. Gao, MD, Post Doctoral Fellow at University of Louisville, Current Address: College of Integrative Medicine Fujian University of Traditional Chinese Medicine Fuzhou, Fujian, China. Adler, MD, Department of Psychiatry University of Cincinnati Cincinnati, Ohio.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32214517

Citation

El-Mallakh, Rif S., et al. "Asenapine in the Treatment of Bipolar Depression." Psychopharmacology Bulletin, vol. 50, no. 1, 2020, pp. 8-18.
El-Mallakh RS, Nuss S, Gao D, et al. Asenapine in the Treatment of Bipolar Depression. Psychopharmacol Bull. 2020;50(1):8-18.
El-Mallakh, R. S., Nuss, S., Gao, D., Gao, Y., Ahmad, S. C., Schrodt, C., & Adler, C. (2020). Asenapine in the Treatment of Bipolar Depression. Psychopharmacology Bulletin, 50(1), 8-18.
El-Mallakh RS, et al. Asenapine in the Treatment of Bipolar Depression. Psychopharmacol Bull. 2020 Mar 12;50(1):8-18. PubMed PMID: 32214517.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Asenapine in the Treatment of Bipolar Depression. AU - El-Mallakh,Rif S, AU - Nuss,Sharon, AU - Gao,Dong, AU - Gao,Yonglin, AU - Ahmad,Surriya Colleen, AU - Schrodt,Clare, AU - Adler,Caleb, PY - 2021/03/12/pmc-release PY - 2020/3/28/entrez PY - 2020/3/28/pubmed PY - 2020/3/28/medline KW - anxiety KW - asenapine KW - bipolar depression KW - bipolar disorder KW - depression KW - serotonin transporter SP - 8 EP - 18 JF - Psychopharmacology bulletin JO - Psychopharmacol Bull VL - 50 IS - 1 N2 - 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. SN - 2472-2448 UR - https://www.unboundmedicine.com/medline/citation/32214517/Asenapine_in_the_Treatment_of_Bipolar_Depression L2 - https://medworksmedia.com/product/asenapine-in-the-treatment-of-bipolar-depression/ DB - PRIME DP - Unbound Medicine ER -
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