Cariprazine for the treatment of bipolar mania with mixed features: A post hoc pooled analysis of 3 trials
•Bipolar I disorder mixed features are frequently misdiagnosed, improperly treated.•Mixed features were identified using DSM-5 and 2 proxy criteria.•Pooled patients from 3 studies were stratified post hoc using the 3 criteria.•Post hoc analyses assessed cariprazine efficacy in mixed feature episodes...
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| Veröffentlicht in: | Journal of affective disorders 2019-10, Vol.257, p.600-606 |
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| creator | McIntyre, Roger S. Masand, Prakash S. Earley, Willie Patel, Mehul |
| description | •Bipolar I disorder mixed features are frequently misdiagnosed, improperly treated.•Mixed features were identified using DSM-5 and 2 proxy criteria.•Pooled patients from 3 studies were stratified post hoc using the 3 criteria.•Post hoc analyses assessed cariprazine efficacy in mixed feature episodes.•Cariprazine effectively treated manic and depressive symptoms in mixed episodes.
Background: When bipolar I disorder (BP-I) mania is accompanied by subsyndromal depressive symptoms, a more complicated illness presentation results. To qualify for the mixed features specifier during mania, the DSM-5 requires ≥3 “non-overlapping” depressive symptoms (DS); notwithstanding, concerns of this definition's ecological validity and implications for timely diagnosis remain.
Methods: Herein, patients were pooled from three similarly-designed pivotal trials of cariprazine compared to placebo for BP-I mania (NCT00488618/NCT01058096/NCT01058668) in post hoc analyses of mixed features using three criteria: ≥3 DS (DSM-5), ≥2 DS, and Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥10. Efficacy of cariprazine compared to placebo was assessed (Week 3) by Young Mania Rating Scale (YMRS) and MADRS scores and rates of mania response and remission.
Results: In pooled patients (N = 1037), cariprazine significantly improved mean YMRS scores compared to placebo for each criterion; LSMDs were ≥3 DS = -3.79 (P = .0248), ≥2 DS = -2.91 (P = .0207), and ≥10 MADRS = -5.49 (P |
| doi_str_mv | 10.1016/j.jad.2019.07.020 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2265769285</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0165032718322092</els_id><sourcerecordid>2265769285</sourcerecordid><originalsourceid>FETCH-LOGICAL-c396t-e886dbfbd7cc8c4364ca9b3fab3b514e4545f90a491d2d49391dad62f6ea7b0e3</originalsourceid><addsrcrecordid>eNp9kE1v1DAQhq0K1C6FH8AF-cglwd9O4FStWlqpEhc4W4490TpK4mB7gfLr8WoLR07vSPPMK82D0FtKWkqo-jC1k_UtI7RviW4JIxdoR6XmDZNUv0C7ysiGcKav0KucJ0KI6jW5RFecciEk63Zo2tsUtmR_hxXwGBMuB8AlgS0LrAXHEQ9hi7NNeLFrsPhnKAe8hF_g8VihY4L8Ed_gLeaCD9HVIc51Z1c7P-WQTwW89gU759fo5VgD3jznNfp2d_t1f988fvn8sL95bBzvVWmg65QfxsFr5zonuBLO9gMf7cAHSQUIKeTYEyt66pkXPa9pvWKjAqsHAvwavT_3bil-P0IuZgnZwTzbFeIxG8aU1KpnnawoPaMuxZwTjGZLYbHpyVBiTorNZKpic1JsiDZVcb1591x_HBbw_y7-Oq3ApzMA9ckfAZLJLsDqwIcErhgfw3_q_wDBSY05</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2265769285</pqid></control><display><type>article</type><title>Cariprazine for the treatment of bipolar mania with mixed features: A post hoc pooled analysis of 3 trials</title><source>Elsevier ScienceDirect Journals Complete</source><creator>McIntyre, Roger S. ; Masand, Prakash S. ; Earley, Willie ; Patel, Mehul</creator><creatorcontrib>McIntyre, Roger S. ; Masand, Prakash S. ; Earley, Willie ; Patel, Mehul</creatorcontrib><description>•Bipolar I disorder mixed features are frequently misdiagnosed, improperly treated.•Mixed features were identified using DSM-5 and 2 proxy criteria.•Pooled patients from 3 studies were stratified post hoc using the 3 criteria.•Post hoc analyses assessed cariprazine efficacy in mixed feature episodes.•Cariprazine effectively treated manic and depressive symptoms in mixed episodes.
Background: When bipolar I disorder (BP-I) mania is accompanied by subsyndromal depressive symptoms, a more complicated illness presentation results. To qualify for the mixed features specifier during mania, the DSM-5 requires ≥3 “non-overlapping” depressive symptoms (DS); notwithstanding, concerns of this definition's ecological validity and implications for timely diagnosis remain.
Methods: Herein, patients were pooled from three similarly-designed pivotal trials of cariprazine compared to placebo for BP-I mania (NCT00488618/NCT01058096/NCT01058668) in post hoc analyses of mixed features using three criteria: ≥3 DS (DSM-5), ≥2 DS, and Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥10. Efficacy of cariprazine compared to placebo was assessed (Week 3) by Young Mania Rating Scale (YMRS) and MADRS scores and rates of mania response and remission.
Results: In pooled patients (N = 1037), cariprazine significantly improved mean YMRS scores compared to placebo for each criterion; LSMDs were ≥3 DS = -3.79 (P = .0248), ≥2 DS = -2.91 (P = .0207), and ≥10 MADRS = -5.49 (P < .0001). More cariprazine- than placebo-treated patients met YMRS response and remission criteria, reaching significance for response in ≥2 DS (34% versus 47%; number-needed-to-treat [NNT] = 8, P = .0483) and ≥10 MADRS
(31% versus 57%, NNT = 4, P < .0001) and for remission in ≥2 DS (27% versus 39%, NNT = 9, P = .0462), ≥10 MADRS (23% versus 44%, NNT = 5, P < .0001). Depressive symptoms were improved compared to placebo, reaching statistical significance in the MADRS ≥10 subgroup (LSMD = -1.59, P = .0082).
Limitations: Post hoc analysis, MADRS < 18 entry criterion may have prevented assessment of MADRS changes.
Conclusions: Cariprazine significantly reduced manic and depressive symptoms in patients with mixed features with differential efficacy across the subgroups analyzed herein.</description><identifier>ISSN: 0165-0327</identifier><identifier>EISSN: 1573-2517</identifier><identifier>DOI: 10.1016/j.jad.2019.07.020</identifier><identifier>PMID: 31344528</identifier><language>eng</language><publisher>Netherlands: Elsevier B.V</publisher><subject>Atypical antipsychotic ; Bipolar disorder ; Bipolar mania ; Cariprazine ; Mixed episodes ; Mixed features</subject><ispartof>Journal of affective disorders, 2019-10, Vol.257, p.600-606</ispartof><rights>2019</rights><rights>Copyright © 2019. Published by Elsevier B.V.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c396t-e886dbfbd7cc8c4364ca9b3fab3b514e4545f90a491d2d49391dad62f6ea7b0e3</citedby><cites>FETCH-LOGICAL-c396t-e886dbfbd7cc8c4364ca9b3fab3b514e4545f90a491d2d49391dad62f6ea7b0e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0165032718322092$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31344528$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>McIntyre, Roger S.</creatorcontrib><creatorcontrib>Masand, Prakash S.</creatorcontrib><creatorcontrib>Earley, Willie</creatorcontrib><creatorcontrib>Patel, Mehul</creatorcontrib><title>Cariprazine for the treatment of bipolar mania with mixed features: A post hoc pooled analysis of 3 trials</title><title>Journal of affective disorders</title><addtitle>J Affect Disord</addtitle><description>•Bipolar I disorder mixed features are frequently misdiagnosed, improperly treated.•Mixed features were identified using DSM-5 and 2 proxy criteria.•Pooled patients from 3 studies were stratified post hoc using the 3 criteria.•Post hoc analyses assessed cariprazine efficacy in mixed feature episodes.•Cariprazine effectively treated manic and depressive symptoms in mixed episodes.
Background: When bipolar I disorder (BP-I) mania is accompanied by subsyndromal depressive symptoms, a more complicated illness presentation results. To qualify for the mixed features specifier during mania, the DSM-5 requires ≥3 “non-overlapping” depressive symptoms (DS); notwithstanding, concerns of this definition's ecological validity and implications for timely diagnosis remain.
Methods: Herein, patients were pooled from three similarly-designed pivotal trials of cariprazine compared to placebo for BP-I mania (NCT00488618/NCT01058096/NCT01058668) in post hoc analyses of mixed features using three criteria: ≥3 DS (DSM-5), ≥2 DS, and Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥10. Efficacy of cariprazine compared to placebo was assessed (Week 3) by Young Mania Rating Scale (YMRS) and MADRS scores and rates of mania response and remission.
Results: In pooled patients (N = 1037), cariprazine significantly improved mean YMRS scores compared to placebo for each criterion; LSMDs were ≥3 DS = -3.79 (P = .0248), ≥2 DS = -2.91 (P = .0207), and ≥10 MADRS = -5.49 (P < .0001). More cariprazine- than placebo-treated patients met YMRS response and remission criteria, reaching significance for response in ≥2 DS (34% versus 47%; number-needed-to-treat [NNT] = 8, P = .0483) and ≥10 MADRS
(31% versus 57%, NNT = 4, P < .0001) and for remission in ≥2 DS (27% versus 39%, NNT = 9, P = .0462), ≥10 MADRS (23% versus 44%, NNT = 5, P < .0001). Depressive symptoms were improved compared to placebo, reaching statistical significance in the MADRS ≥10 subgroup (LSMD = -1.59, P = .0082).
Limitations: Post hoc analysis, MADRS < 18 entry criterion may have prevented assessment of MADRS changes.
Conclusions: Cariprazine significantly reduced manic and depressive symptoms in patients with mixed features with differential efficacy across the subgroups analyzed herein.</description><subject>Atypical antipsychotic</subject><subject>Bipolar disorder</subject><subject>Bipolar mania</subject><subject>Cariprazine</subject><subject>Mixed episodes</subject><subject>Mixed features</subject><issn>0165-0327</issn><issn>1573-2517</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><recordid>eNp9kE1v1DAQhq0K1C6FH8AF-cglwd9O4FStWlqpEhc4W4490TpK4mB7gfLr8WoLR07vSPPMK82D0FtKWkqo-jC1k_UtI7RviW4JIxdoR6XmDZNUv0C7ysiGcKav0KucJ0KI6jW5RFecciEk63Zo2tsUtmR_hxXwGBMuB8AlgS0LrAXHEQ9hi7NNeLFrsPhnKAe8hF_g8VihY4L8Ed_gLeaCD9HVIc51Z1c7P-WQTwW89gU759fo5VgD3jznNfp2d_t1f988fvn8sL95bBzvVWmg65QfxsFr5zonuBLO9gMf7cAHSQUIKeTYEyt66pkXPa9pvWKjAqsHAvwavT_3bil-P0IuZgnZwTzbFeIxG8aU1KpnnawoPaMuxZwTjGZLYbHpyVBiTorNZKpic1JsiDZVcb1591x_HBbw_y7-Oq3ApzMA9ckfAZLJLsDqwIcErhgfw3_q_wDBSY05</recordid><startdate>20191001</startdate><enddate>20191001</enddate><creator>McIntyre, Roger S.</creator><creator>Masand, Prakash S.</creator><creator>Earley, Willie</creator><creator>Patel, Mehul</creator><general>Elsevier B.V</general><scope>6I.</scope><scope>AAFTH</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20191001</creationdate><title>Cariprazine for the treatment of bipolar mania with mixed features: A post hoc pooled analysis of 3 trials</title><author>McIntyre, Roger S. ; Masand, Prakash S. ; Earley, Willie ; Patel, Mehul</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c396t-e886dbfbd7cc8c4364ca9b3fab3b514e4545f90a491d2d49391dad62f6ea7b0e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Atypical antipsychotic</topic><topic>Bipolar disorder</topic><topic>Bipolar mania</topic><topic>Cariprazine</topic><topic>Mixed episodes</topic><topic>Mixed features</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>McIntyre, Roger S.</creatorcontrib><creatorcontrib>Masand, Prakash S.</creatorcontrib><creatorcontrib>Earley, Willie</creatorcontrib><creatorcontrib>Patel, Mehul</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of affective disorders</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>McIntyre, Roger S.</au><au>Masand, Prakash S.</au><au>Earley, Willie</au><au>Patel, Mehul</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Cariprazine for the treatment of bipolar mania with mixed features: A post hoc pooled analysis of 3 trials</atitle><jtitle>Journal of affective disorders</jtitle><addtitle>J Affect Disord</addtitle><date>2019-10-01</date><risdate>2019</risdate><volume>257</volume><spage>600</spage><epage>606</epage><pages>600-606</pages><issn>0165-0327</issn><eissn>1573-2517</eissn><abstract>•Bipolar I disorder mixed features are frequently misdiagnosed, improperly treated.•Mixed features were identified using DSM-5 and 2 proxy criteria.•Pooled patients from 3 studies were stratified post hoc using the 3 criteria.•Post hoc analyses assessed cariprazine efficacy in mixed feature episodes.•Cariprazine effectively treated manic and depressive symptoms in mixed episodes.
Background: When bipolar I disorder (BP-I) mania is accompanied by subsyndromal depressive symptoms, a more complicated illness presentation results. To qualify for the mixed features specifier during mania, the DSM-5 requires ≥3 “non-overlapping” depressive symptoms (DS); notwithstanding, concerns of this definition's ecological validity and implications for timely diagnosis remain.
Methods: Herein, patients were pooled from three similarly-designed pivotal trials of cariprazine compared to placebo for BP-I mania (NCT00488618/NCT01058096/NCT01058668) in post hoc analyses of mixed features using three criteria: ≥3 DS (DSM-5), ≥2 DS, and Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥10. Efficacy of cariprazine compared to placebo was assessed (Week 3) by Young Mania Rating Scale (YMRS) and MADRS scores and rates of mania response and remission.
Results: In pooled patients (N = 1037), cariprazine significantly improved mean YMRS scores compared to placebo for each criterion; LSMDs were ≥3 DS = -3.79 (P = .0248), ≥2 DS = -2.91 (P = .0207), and ≥10 MADRS = -5.49 (P < .0001). More cariprazine- than placebo-treated patients met YMRS response and remission criteria, reaching significance for response in ≥2 DS (34% versus 47%; number-needed-to-treat [NNT] = 8, P = .0483) and ≥10 MADRS
(31% versus 57%, NNT = 4, P < .0001) and for remission in ≥2 DS (27% versus 39%, NNT = 9, P = .0462), ≥10 MADRS (23% versus 44%, NNT = 5, P < .0001). Depressive symptoms were improved compared to placebo, reaching statistical significance in the MADRS ≥10 subgroup (LSMD = -1.59, P = .0082).
Limitations: Post hoc analysis, MADRS < 18 entry criterion may have prevented assessment of MADRS changes.
Conclusions: Cariprazine significantly reduced manic and depressive symptoms in patients with mixed features with differential efficacy across the subgroups analyzed herein.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>31344528</pmid><doi>10.1016/j.jad.2019.07.020</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Atypical antipsychotic Bipolar disorder Bipolar mania Cariprazine Mixed episodes Mixed features |
| title | Cariprazine for the treatment of bipolar mania with mixed features: A post hoc pooled analysis of 3 trials |
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