Adjunctive Brexpiprazole and Functioning in Major Depressive Disorder: A Pooled Analysis of Six Randomized Studies Using the Sheehan Disability Scale
Abstract Background Patients with major depressive disorder and inadequate response to antidepressant treatments may experience a prolonged loss of functioning. This post hoc analysis aimed to determine the effect of adjunctive brexpiprazole on functioning in such patients. Methods A pooled analysis...
Gespeichert in:
| Veröffentlicht in: | The international journal of neuropsychopharmacology 2019-03, Vol.22 (3), p.173-179 |
|---|---|
| Hauptverfasser: | , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 179 |
|---|---|
| container_issue | 3 |
| container_start_page | 173 |
| container_title | The international journal of neuropsychopharmacology |
| container_volume | 22 |
| creator | Hobart, Mary Zhang, Peter Weiss, Catherine Meehan, Stine Rasmussen Eriksson, Hans |
| description | Abstract
Background
Patients with major depressive disorder and inadequate response to antidepressant treatments may experience a prolonged loss of functioning. This post hoc analysis aimed to determine the effect of adjunctive brexpiprazole on functioning in such patients.
Methods
A pooled analysis of data from the 6-week, randomized, double-blind treatment phases of 6 studies of adjunctive brexpiprazole (2 and 3 mg/d in fixed-dose studies; 1–3 mg/d in flexible-dose studies) vs placebo in patients with major depressive disorder and inadequate response to antidepressant treatments (NCT01360645, NCT01360632, NCT02196506, NCT01727726, NCT00797966, NCT01052077). Functioning was measured by change in Sheehan Disability Scale score from baseline to week 6.
Results
Considering Sheehan Disability Scale mean score across all 6 studies (n = 2066 randomized), the least squares mean difference between antidepressant treatments + brexpiprazole and antidepressant treatments + placebo at week 6 was −0.40 (95% CI: −0.56, −0.23; P < .0001). Antidepressant treatments + brexpiprazole showed a greater benefit than antidepressant treatments + placebo on the social life (−0.45; −0.63, −0.27; P < .001) and family life (−0.50; −0.70, −0.31; P < .001) items but not on the work/studies item (−0.16; −0.38, 0.06; P = .16). Pooled analyses of just the (1) fixed-dose, (2) flexible-dose, and (3) Phase 3 studies showed the same pattern of benefits for antidepressant treatments + brexpiprazole.
Conclusions
Brexpiprazole, as adjunct to antidepressant treatments, improved functioning in patients with major depressive disorder and inadequate response to antidepressant treatments. |
| doi_str_mv | 10.1093/ijnp/pyy095 |
| format | Article |
| fullrecord | <record><control><sourceid>gale_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6403084</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A613204216</galeid><oup_id>10.1093/ijnp/pyy095</oup_id><sourcerecordid>A613204216</sourcerecordid><originalsourceid>FETCH-LOGICAL-c479t-86fa6684da7754687b1c3d5212b68f499a52815276e323452c1b2bf8122d0d163</originalsourceid><addsrcrecordid>eNp9klFr1TAUx4sobk6ffJeAIIJ0S9I0TX0Q6uZUmChe9xzS5vTeXHqTmrRj3ffw-5rezuFAJA8JOb_z4xz4J8lzgo8JLrMTs7X9ST9NuMwfJIeE8TLNCSEP92-SEpYXB8mTELYYU5Zn_HFykOEcC1ziw-RXpbejbQZzBei9h-ve9F7duA6Qshqd70vOGrtGxqIvaus8OoPeQwhzx5kJzmvwb1GFvrnYpVFlVTcFE5Br0cpco-_R43bmJpZWw6gNBHQZZt-wAbTaAGyUnT2qNp0ZJrRqVAdPk0et6gI8u72PksvzDz9OP6UXXz9-Pq0u0oYV5ZAK3irOBdOqKHLGRVGTJtM5JbTmomVlqXIqSE4LDhnNWE4bUtO6FYRSjTXh2VHybvH2Y70D3YAdvOpk781O-Uk6ZeT9ijUbuXZXkjOcYcGi4PWtwLufI4RB7kxooOuUBTcGSQkrBRMFLSL6ckHXcUFpbOuisZlxWXGSUczofqLjf1DxaNiZxlloTfy_1_BmaWi8C8FDezc9wXLOh5zzIZd8RPrF3wvfsX8CEYFXC-DG_r-m38g2xZE</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2149848727</pqid></control><display><type>article</type><title>Adjunctive Brexpiprazole and Functioning in Major Depressive Disorder: A Pooled Analysis of Six Randomized Studies Using the Sheehan Disability Scale</title><source>Oxford Journals Open Access Collection</source><source>MEDLINE</source><source>DOAJ Directory of Open Access Journals</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>PubMed Central</source><creator>Hobart, Mary ; Zhang, Peter ; Weiss, Catherine ; Meehan, Stine Rasmussen ; Eriksson, Hans</creator><creatorcontrib>Hobart, Mary ; Zhang, Peter ; Weiss, Catherine ; Meehan, Stine Rasmussen ; Eriksson, Hans</creatorcontrib><description>Abstract
Background
Patients with major depressive disorder and inadequate response to antidepressant treatments may experience a prolonged loss of functioning. This post hoc analysis aimed to determine the effect of adjunctive brexpiprazole on functioning in such patients.
Methods
A pooled analysis of data from the 6-week, randomized, double-blind treatment phases of 6 studies of adjunctive brexpiprazole (2 and 3 mg/d in fixed-dose studies; 1–3 mg/d in flexible-dose studies) vs placebo in patients with major depressive disorder and inadequate response to antidepressant treatments (NCT01360645, NCT01360632, NCT02196506, NCT01727726, NCT00797966, NCT01052077). Functioning was measured by change in Sheehan Disability Scale score from baseline to week 6.
Results
Considering Sheehan Disability Scale mean score across all 6 studies (n = 2066 randomized), the least squares mean difference between antidepressant treatments + brexpiprazole and antidepressant treatments + placebo at week 6 was −0.40 (95% CI: −0.56, −0.23; P < .0001). Antidepressant treatments + brexpiprazole showed a greater benefit than antidepressant treatments + placebo on the social life (−0.45; −0.63, −0.27; P < .001) and family life (−0.50; −0.70, −0.31; P < .001) items but not on the work/studies item (−0.16; −0.38, 0.06; P = .16). Pooled analyses of just the (1) fixed-dose, (2) flexible-dose, and (3) Phase 3 studies showed the same pattern of benefits for antidepressant treatments + brexpiprazole.
Conclusions
Brexpiprazole, as adjunct to antidepressant treatments, improved functioning in patients with major depressive disorder and inadequate response to antidepressant treatments.</description><identifier>ISSN: 1461-1457</identifier><identifier>ISSN: 1469-5111</identifier><identifier>EISSN: 1469-5111</identifier><identifier>DOI: 10.1093/ijnp/pyy095</identifier><identifier>PMID: 30508090</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>Antidepressants ; Antidepressive Agents - administration & dosage ; Brexpiprazole ; Depression (Mood disorder) ; Depressive Disorder, Major - diagnosis ; Depressive Disorder, Major - drug therapy ; Depressive Disorder, Major - psychology ; Disabilities ; Disability Evaluation ; Dosage and administration ; Double-Blind Method ; Drug therapy ; Drug Therapy, Combination ; Family life ; Humans ; Major depressive disorder ; Medical research ; Patient outcomes ; Prospective Studies ; Quinolones - administration & dosage ; Randomized Controlled Trials as Topic - methods ; Regular ; Retirement benefits ; Serotonin Agents - administration & dosage ; Single-Blind Method ; Thiophenes - administration & dosage</subject><ispartof>The international journal of neuropsychopharmacology, 2019-03, Vol.22 (3), p.173-179</ispartof><rights>The Author(s) 2018. Published by Oxford University Press on behalf of CINP. 2018</rights><rights>The Author(s) 2018. Published by Oxford University Press on behalf of CINP.</rights><rights>COPYRIGHT 2019 Oxford University Press</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c479t-86fa6684da7754687b1c3d5212b68f499a52815276e323452c1b2bf8122d0d163</citedby><cites>FETCH-LOGICAL-c479t-86fa6684da7754687b1c3d5212b68f499a52815276e323452c1b2bf8122d0d163</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6403084/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6403084/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,1598,27903,27904,53769,53771</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30508090$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hobart, Mary</creatorcontrib><creatorcontrib>Zhang, Peter</creatorcontrib><creatorcontrib>Weiss, Catherine</creatorcontrib><creatorcontrib>Meehan, Stine Rasmussen</creatorcontrib><creatorcontrib>Eriksson, Hans</creatorcontrib><title>Adjunctive Brexpiprazole and Functioning in Major Depressive Disorder: A Pooled Analysis of Six Randomized Studies Using the Sheehan Disability Scale</title><title>The international journal of neuropsychopharmacology</title><addtitle>Int J Neuropsychopharmacol</addtitle><description>Abstract
Background
Patients with major depressive disorder and inadequate response to antidepressant treatments may experience a prolonged loss of functioning. This post hoc analysis aimed to determine the effect of adjunctive brexpiprazole on functioning in such patients.
Methods
A pooled analysis of data from the 6-week, randomized, double-blind treatment phases of 6 studies of adjunctive brexpiprazole (2 and 3 mg/d in fixed-dose studies; 1–3 mg/d in flexible-dose studies) vs placebo in patients with major depressive disorder and inadequate response to antidepressant treatments (NCT01360645, NCT01360632, NCT02196506, NCT01727726, NCT00797966, NCT01052077). Functioning was measured by change in Sheehan Disability Scale score from baseline to week 6.
Results
Considering Sheehan Disability Scale mean score across all 6 studies (n = 2066 randomized), the least squares mean difference between antidepressant treatments + brexpiprazole and antidepressant treatments + placebo at week 6 was −0.40 (95% CI: −0.56, −0.23; P < .0001). Antidepressant treatments + brexpiprazole showed a greater benefit than antidepressant treatments + placebo on the social life (−0.45; −0.63, −0.27; P < .001) and family life (−0.50; −0.70, −0.31; P < .001) items but not on the work/studies item (−0.16; −0.38, 0.06; P = .16). Pooled analyses of just the (1) fixed-dose, (2) flexible-dose, and (3) Phase 3 studies showed the same pattern of benefits for antidepressant treatments + brexpiprazole.
Conclusions
Brexpiprazole, as adjunct to antidepressant treatments, improved functioning in patients with major depressive disorder and inadequate response to antidepressant treatments.</description><subject>Antidepressants</subject><subject>Antidepressive Agents - administration & dosage</subject><subject>Brexpiprazole</subject><subject>Depression (Mood disorder)</subject><subject>Depressive Disorder, Major - diagnosis</subject><subject>Depressive Disorder, Major - drug therapy</subject><subject>Depressive Disorder, Major - psychology</subject><subject>Disabilities</subject><subject>Disability Evaluation</subject><subject>Dosage and administration</subject><subject>Double-Blind Method</subject><subject>Drug therapy</subject><subject>Drug Therapy, Combination</subject><subject>Family life</subject><subject>Humans</subject><subject>Major depressive disorder</subject><subject>Medical research</subject><subject>Patient outcomes</subject><subject>Prospective Studies</subject><subject>Quinolones - administration & dosage</subject><subject>Randomized Controlled Trials as Topic - methods</subject><subject>Regular</subject><subject>Retirement benefits</subject><subject>Serotonin Agents - administration & dosage</subject><subject>Single-Blind Method</subject><subject>Thiophenes - administration & dosage</subject><issn>1461-1457</issn><issn>1469-5111</issn><issn>1469-5111</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>TOX</sourceid><sourceid>EIF</sourceid><recordid>eNp9klFr1TAUx4sobk6ffJeAIIJ0S9I0TX0Q6uZUmChe9xzS5vTeXHqTmrRj3ffw-5rezuFAJA8JOb_z4xz4J8lzgo8JLrMTs7X9ST9NuMwfJIeE8TLNCSEP92-SEpYXB8mTELYYU5Zn_HFykOEcC1ziw-RXpbejbQZzBei9h-ve9F7duA6Qshqd70vOGrtGxqIvaus8OoPeQwhzx5kJzmvwb1GFvrnYpVFlVTcFE5Br0cpco-_R43bmJpZWw6gNBHQZZt-wAbTaAGyUnT2qNp0ZJrRqVAdPk0et6gI8u72PksvzDz9OP6UXXz9-Pq0u0oYV5ZAK3irOBdOqKHLGRVGTJtM5JbTmomVlqXIqSE4LDhnNWE4bUtO6FYRSjTXh2VHybvH2Y70D3YAdvOpk781O-Uk6ZeT9ijUbuXZXkjOcYcGi4PWtwLufI4RB7kxooOuUBTcGSQkrBRMFLSL6ckHXcUFpbOuisZlxWXGSUczofqLjf1DxaNiZxlloTfy_1_BmaWi8C8FDezc9wXLOh5zzIZd8RPrF3wvfsX8CEYFXC-DG_r-m38g2xZE</recordid><startdate>20190301</startdate><enddate>20190301</enddate><creator>Hobart, Mary</creator><creator>Zhang, Peter</creator><creator>Weiss, Catherine</creator><creator>Meehan, Stine Rasmussen</creator><creator>Eriksson, Hans</creator><general>Oxford University Press</general><scope>TOX</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20190301</creationdate><title>Adjunctive Brexpiprazole and Functioning in Major Depressive Disorder: A Pooled Analysis of Six Randomized Studies Using the Sheehan Disability Scale</title><author>Hobart, Mary ; Zhang, Peter ; Weiss, Catherine ; Meehan, Stine Rasmussen ; Eriksson, Hans</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c479t-86fa6684da7754687b1c3d5212b68f499a52815276e323452c1b2bf8122d0d163</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Antidepressants</topic><topic>Antidepressive Agents - administration & dosage</topic><topic>Brexpiprazole</topic><topic>Depression (Mood disorder)</topic><topic>Depressive Disorder, Major - diagnosis</topic><topic>Depressive Disorder, Major - drug therapy</topic><topic>Depressive Disorder, Major - psychology</topic><topic>Disabilities</topic><topic>Disability Evaluation</topic><topic>Dosage and administration</topic><topic>Double-Blind Method</topic><topic>Drug therapy</topic><topic>Drug Therapy, Combination</topic><topic>Family life</topic><topic>Humans</topic><topic>Major depressive disorder</topic><topic>Medical research</topic><topic>Patient outcomes</topic><topic>Prospective Studies</topic><topic>Quinolones - administration & dosage</topic><topic>Randomized Controlled Trials as Topic - methods</topic><topic>Regular</topic><topic>Retirement benefits</topic><topic>Serotonin Agents - administration & dosage</topic><topic>Single-Blind Method</topic><topic>Thiophenes - administration & dosage</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hobart, Mary</creatorcontrib><creatorcontrib>Zhang, Peter</creatorcontrib><creatorcontrib>Weiss, Catherine</creatorcontrib><creatorcontrib>Meehan, Stine Rasmussen</creatorcontrib><creatorcontrib>Eriksson, Hans</creatorcontrib><collection>Oxford Journals Open Access Collection</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>The international journal of neuropsychopharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hobart, Mary</au><au>Zhang, Peter</au><au>Weiss, Catherine</au><au>Meehan, Stine Rasmussen</au><au>Eriksson, Hans</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Adjunctive Brexpiprazole and Functioning in Major Depressive Disorder: A Pooled Analysis of Six Randomized Studies Using the Sheehan Disability Scale</atitle><jtitle>The international journal of neuropsychopharmacology</jtitle><addtitle>Int J Neuropsychopharmacol</addtitle><date>2019-03-01</date><risdate>2019</risdate><volume>22</volume><issue>3</issue><spage>173</spage><epage>179</epage><pages>173-179</pages><issn>1461-1457</issn><issn>1469-5111</issn><eissn>1469-5111</eissn><abstract>Abstract
Background
Patients with major depressive disorder and inadequate response to antidepressant treatments may experience a prolonged loss of functioning. This post hoc analysis aimed to determine the effect of adjunctive brexpiprazole on functioning in such patients.
Methods
A pooled analysis of data from the 6-week, randomized, double-blind treatment phases of 6 studies of adjunctive brexpiprazole (2 and 3 mg/d in fixed-dose studies; 1–3 mg/d in flexible-dose studies) vs placebo in patients with major depressive disorder and inadequate response to antidepressant treatments (NCT01360645, NCT01360632, NCT02196506, NCT01727726, NCT00797966, NCT01052077). Functioning was measured by change in Sheehan Disability Scale score from baseline to week 6.
Results
Considering Sheehan Disability Scale mean score across all 6 studies (n = 2066 randomized), the least squares mean difference between antidepressant treatments + brexpiprazole and antidepressant treatments + placebo at week 6 was −0.40 (95% CI: −0.56, −0.23; P < .0001). Antidepressant treatments + brexpiprazole showed a greater benefit than antidepressant treatments + placebo on the social life (−0.45; −0.63, −0.27; P < .001) and family life (−0.50; −0.70, −0.31; P < .001) items but not on the work/studies item (−0.16; −0.38, 0.06; P = .16). Pooled analyses of just the (1) fixed-dose, (2) flexible-dose, and (3) Phase 3 studies showed the same pattern of benefits for antidepressant treatments + brexpiprazole.
Conclusions
Brexpiprazole, as adjunct to antidepressant treatments, improved functioning in patients with major depressive disorder and inadequate response to antidepressant treatments.</abstract><cop>US</cop><pub>Oxford University Press</pub><pmid>30508090</pmid><doi>10.1093/ijnp/pyy095</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1461-1457 |
| ispartof | The international journal of neuropsychopharmacology, 2019-03, Vol.22 (3), p.173-179 |
| issn | 1461-1457 1469-5111 1469-5111 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6403084 |
| source | Oxford Journals Open Access Collection; MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central |
| subjects | Antidepressants Antidepressive Agents - administration & dosage Brexpiprazole Depression (Mood disorder) Depressive Disorder, Major - diagnosis Depressive Disorder, Major - drug therapy Depressive Disorder, Major - psychology Disabilities Disability Evaluation Dosage and administration Double-Blind Method Drug therapy Drug Therapy, Combination Family life Humans Major depressive disorder Medical research Patient outcomes Prospective Studies Quinolones - administration & dosage Randomized Controlled Trials as Topic - methods Regular Retirement benefits Serotonin Agents - administration & dosage Single-Blind Method Thiophenes - administration & dosage |
| title | Adjunctive Brexpiprazole and Functioning in Major Depressive Disorder: A Pooled Analysis of Six Randomized Studies Using the Sheehan Disability Scale |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-27T06%3A40%3A40IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Adjunctive%20Brexpiprazole%20and%20Functioning%20in%20Major%20Depressive%20Disorder:%20A%20Pooled%20Analysis%20of%20Six%20Randomized%20Studies%20Using%20the%20Sheehan%20Disability%20Scale&rft.jtitle=The%20international%20journal%20of%20neuropsychopharmacology&rft.au=Hobart,%20Mary&rft.date=2019-03-01&rft.volume=22&rft.issue=3&rft.spage=173&rft.epage=179&rft.pages=173-179&rft.issn=1461-1457&rft.eissn=1469-5111&rft_id=info:doi/10.1093/ijnp/pyy095&rft_dat=%3Cgale_pubme%3EA613204216%3C/gale_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2149848727&rft_id=info:pmid/30508090&rft_galeid=A613204216&rft_oup_id=10.1093/ijnp/pyy095&rfr_iscdi=true |