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Efficacy of asenapine in manic episodes with depressive symptoms: A review of post-hoc analyses

Young, Allan H; Eberhard, Jonas LU and Weiller, Emmanuelle (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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author
publishing date
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
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
2017-08-07 14:40:59
@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.},
  articleno    = {P63},
  author       = {Young, Allan H and Eberhard, Jonas and Weiller, Emmanuelle},
  issn         = {1471-1788},
  keyword      = {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},
  volume       = {17},
  year         = {2013},
}