Efficacy of asenapine in manic episodes with depressive symptoms: A review of post-hoc analyses
(2013) In International Journal of Psychiatry in Clinical Practice 17(Suppl 2). p.36-37- Abstract
- Background: Manic episodes with depressive symptoms represent a severe presentation of bipolar disorder. The effi-cacy of drugs shown useful for pure mania is largely unproven in the subset of patients with depressive symptoms. We reviewed different post-hoc analyses evaluating asenapine's effects in patients experiencing depressive symptoms during manic episodes. Methods: Different post-hoc analyses have been conducted using pooled data of two 3-week, randomized, placebo-and olanzapine-controlled trials. 1,2 Different definitions have been used to ascertain the presence of clinically relevant depressive symptoms at baseline: MADRS total score ≥ 20, CGI-BP-D scale severity score ≥ 4, DSM-IV mixed episode; 3,4 DSM-IV mixed episode with... (More)
- Background: Manic episodes with depressive symptoms represent a severe presentation of bipolar disorder. The effi-cacy of drugs shown useful for pure mania is largely unproven in the subset of patients with depressive symptoms. We reviewed different post-hoc analyses evaluating asenapine's effects in patients experiencing depressive symptoms during manic episodes. Methods: Different post-hoc analyses have been conducted using pooled data of two 3-week, randomized, placebo-and olanzapine-controlled trials. 1,2 Different definitions have been used to ascertain the presence of clinically relevant depressive symptoms at baseline: MADRS total score ≥ 20, CGI-BP-D scale severity score ≥ 4, DSM-IV mixed episode; 3,4 DSM-IV mixed episode with MADRS total score ≥ 20; 5 DSM-5 mixed features using different severity cut offs. 6 For each population, asenapine and olanzapine were compared with placebo on different depression endpoint (remission rates: MADRS ≤ 12, mean change in MADRS total score). Effect on manic symptoms was also assessed in some populations (remission rates: YMRS ≤ 12, mean change in YMRS total score) end points. Results: In all populations, asenapine was significantly superior to placebo at days 7 and 21 in reducing depressive symptoms and significantly superior to olanzapine at day 7. In a few populations, olanzapine also tended to improve depressive symptoms at day 21. Asenapine significantly improved manic symptoms as compared to placebo as early as day 2 in patients with DSM-IV mixed episodes or DSM-5 mixed features, and was significantly superior to olanzapine at day 2 in patients with the most severe depressive symptoms. Olanzapine did not separate from placebo in reducing manic symptoms severity. Conclusion: In all post-hoc analyses asenapine signifi-cantly improved both manic and depressive symptoms in bipolar patients experiencing manic episodes with depressive symptoms. Anti-manic agents appear to have differential efficacy in people who experience depressive symptoms during a manic episode. (Less)
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https://lup.lub.lu.se/record/f2434ab0-71fc-4218-a7f6-880bca799efe
- author
- Young, Allan H ; Eberhard, Jonas LU and Weiller, Emmanuelle
- publishing date
- 2013-12-01
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- asenapine, olanzapine, placebo, mania, depression, post hoc analysis, mood, anxiety disorder, human, patient, population, mixed mania and depression, DSM-5, remission, Montgomery Asberg Depression Rating Scale, Young Mania Rating Scale, controlled study, bipolar disorder
- in
- International Journal of Psychiatry in Clinical Practice
- volume
- 17
- issue
- Suppl 2
- article number
- P63
- pages
- 36 - 37
- publisher
- Informa Healthcare
- ISSN
- 1471-1788
- DOI
- 10.3109/13651501.2013.851555
- language
- English
- LU publication?
- no
- id
- f2434ab0-71fc-4218-a7f6-880bca799efe
- date added to LUP
- 2017-08-06 15:09:50
- date last changed
- 2018-11-21 21:33:44
@misc{f2434ab0-71fc-4218-a7f6-880bca799efe, abstract = {{Background: Manic episodes with depressive symptoms represent a severe presentation of bipolar disorder. The effi-cacy of drugs shown useful for pure mania is largely unproven in the subset of patients with depressive symptoms. We reviewed different post-hoc analyses evaluating asenapine's effects in patients experiencing depressive symptoms during manic episodes. Methods: Different post-hoc analyses have been conducted using pooled data of two 3-week, randomized, placebo-and olanzapine-controlled trials. 1,2 Different definitions have been used to ascertain the presence of clinically relevant depressive symptoms at baseline: MADRS total score ≥ 20, CGI-BP-D scale severity score ≥ 4, DSM-IV mixed episode; 3,4 DSM-IV mixed episode with MADRS total score ≥ 20; 5 DSM-5 mixed features using different severity cut offs. 6 For each population, asenapine and olanzapine were compared with placebo on different depression endpoint (remission rates: MADRS ≤ 12, mean change in MADRS total score). Effect on manic symptoms was also assessed in some populations (remission rates: YMRS ≤ 12, mean change in YMRS total score) end points. Results: In all populations, asenapine was significantly superior to placebo at days 7 and 21 in reducing depressive symptoms and significantly superior to olanzapine at day 7. In a few populations, olanzapine also tended to improve depressive symptoms at day 21. Asenapine significantly improved manic symptoms as compared to placebo as early as day 2 in patients with DSM-IV mixed episodes or DSM-5 mixed features, and was significantly superior to olanzapine at day 2 in patients with the most severe depressive symptoms. Olanzapine did not separate from placebo in reducing manic symptoms severity. Conclusion: In all post-hoc analyses asenapine signifi-cantly improved both manic and depressive symptoms in bipolar patients experiencing manic episodes with depressive symptoms. Anti-manic agents appear to have differential efficacy in people who experience depressive symptoms during a manic episode.}}, author = {{Young, Allan H and Eberhard, Jonas and Weiller, Emmanuelle}}, issn = {{1471-1788}}, keywords = {{asenapine; olanzapine; placebo; mania; depression; post hoc analysis; mood; anxiety disorder; human; patient; population; mixed mania and depression; DSM-5; remission; Montgomery Asberg Depression Rating Scale; Young Mania Rating Scale; controlled study; bipolar disorder}}, language = {{eng}}, month = {{12}}, note = {{Conference Abstract}}, number = {{Suppl 2}}, pages = {{36--37}}, publisher = {{Informa Healthcare}}, series = {{International Journal of Psychiatry in Clinical Practice}}, title = {{Efficacy of asenapine in manic episodes with depressive symptoms: A review of post-hoc analyses}}, url = {{http://dx.doi.org/10.3109/13651501.2013.851555}}, doi = {{10.3109/13651501.2013.851555}}, volume = {{17}}, year = {{2013}}, }