Loading…
Long-term safety and tolerability of open-label aripiprazole augmentation of antidepressant therapy in major depressive disorder
Effective management of major depressive disorder often includes the long-term use of multiple medications, and the longer-term utility and safety of adjunctive aripiprazole has not been evaluated in a controlled setting. Patients (n = 706) completing one of two 14-week double-blind studies of aripi...
Saved in:
Published in: | Neuropsychiatric disease and treatment 2011-01, Vol.7 (1), p.303-312 |
---|---|
Main Authors: | , , , , , , , , |
Format: | Article |
Language: | English |
Subjects: | |
Citations: | Items that cite this one |
Online Access: | Get full text |
Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
cited_by | cdi_FETCH-LOGICAL-c511t-658bb71d4f270ef78bece40277cf33edea47f7ec858a33e0c10239ea6ce0807c3 |
---|---|
cites | |
container_end_page | 312 |
container_issue | 1 |
container_start_page | 303 |
container_title | Neuropsychiatric disease and treatment |
container_volume | 7 |
creator | Berman, Robert M Thase, Michael E Trivedi, Madhukar H Hazel, James A Marler, Sabrina Vogel McQuade, Robert D Carson, William Baker, Ross A Marcus, Ronald N |
description | Effective management of major depressive disorder often includes the long-term use of multiple medications, and the longer-term utility and safety of adjunctive aripiprazole has not been evaluated in a controlled setting.
Patients (n = 706) completing one of two 14-week double-blind studies of aripiprazole augmentation, as well as de novo patients (n = 296) nonresponsive to current antidepressant therapy, were enrolled in this open-label study. Patients received open-label aripiprazole for up to 52 weeks.
Open-label treatment was completed by 323 patients (32.2%). At endpoint (n = 987), the mean dose of aripiprazole was 10.1 mg/day. Common (>15% of patients) spontaneously reported adverse events were akathisia (26.2%), fatigue (18.0%), and weight gain (17.1%). The incidence of serious adverse events was 4.0%. Four spontaneous reports of possible tardive dyskinesia were submitted (0.4%); all resolved within 45 days of drug discontinuation. Mean weight change was 4.4 kg; 36.6% experienced ≥7% increase in weight from baseline (observed case analysis, n = 303). No clinically relevant changes in other metabolic parameters were seen. At the end of open-label treatment, 221 patients (69.7%) had a Clinical Global Impression-Severity of Illness score of 1 (not at all ill) or 2 (borderline ill).
Long-term adjunctive aripiprazole therapy was well tolerated with an acceptable long-term safety and tolerability profile in patients with major depressive disorder who had not responded to treatment with one or more antidepressant therapies. Clinically significant weight gain was observed in about one-third of patients. Overall, the adverse event profile was consistent with that reported in the short-term trials and readily managed clinically. |
doi_str_mv | 10.2147/NDT.S18333 |
format | article |
fullrecord | <record><control><sourceid>proquest_doaj_</sourceid><recordid>TN_cdi_doaj_primary_oai_doaj_org_article_d53a80b7fbd44e37b9347a80c49e2718</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><doaj_id>oai_doaj_org_article_d53a80b7fbd44e37b9347a80c49e2718</doaj_id><sourcerecordid>2222754193</sourcerecordid><originalsourceid>FETCH-LOGICAL-c511t-658bb71d4f270ef78bece40277cf33edea47f7ec858a33e0c10239ea6ce0807c3</originalsourceid><addsrcrecordid>eNpdUk1v1DAQjRCIloULPwBZ4oCElNaOndi5IKHyVWkFB8rZmjiTrVdJHGxnpeXET8fd7Fa0vnj85unN-Oll2WtGLwom5OX3TzcXP5ninD_JzhmTKi9owZ4e6iqveKHOshchbCnlslbqeXZWsKosuRDn2d-1Gzd5RD-QAB3GPYGxJdH16KGxvU2A64ibcMx7aLAn4O1kJw9_EoXAvBlwjBCtG-94MEbb4uQxhFSSeJtUpj2xIxlg6zw59uwOSWuD8y36l9mzDvqAr473Kvv15fPN1bd8_ePr9dXHdW5KxmJelappJGtFV0iKnVQNGhS0kNJ0nGOLIGQn0ahSQXpTw2jBa4TKIFVUGr7Krhfd1sFWT94O4PfagdUHwPmNBh-t6VG3JQdFG9k1rRDIZVNzIRNiRI2FTEavsg-L1jQ3A7YmWeChfyD6sDPaW71xO80ZFZWqk8DlaZndYsmjjU6ocYOW5WHku-NI737PGKIebDDY9zCim4NWknFFS8oS8-0j5tbNfkze6iIdWQpW88R6v7CMdyF47O4XYFTfpUqnVOklVYn85v__3lNPMeL_ADXOzI4</addsrcrecordid><sourcetype>Open Website</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2222754193</pqid></control><display><type>article</type><title>Long-term safety and tolerability of open-label aripiprazole augmentation of antidepressant therapy in major depressive disorder</title><source>Publicly Available Content Database (Proquest) (PQ_SDU_P3)</source><source>Taylor & Francis Open Access</source><source>PubMed Central Free</source><creator>Berman, Robert M ; Thase, Michael E ; Trivedi, Madhukar H ; Hazel, James A ; Marler, Sabrina Vogel ; McQuade, Robert D ; Carson, William ; Baker, Ross A ; Marcus, Ronald N</creator><creatorcontrib>Berman, Robert M ; Thase, Michael E ; Trivedi, Madhukar H ; Hazel, James A ; Marler, Sabrina Vogel ; McQuade, Robert D ; Carson, William ; Baker, Ross A ; Marcus, Ronald N</creatorcontrib><description>Effective management of major depressive disorder often includes the long-term use of multiple medications, and the longer-term utility and safety of adjunctive aripiprazole has not been evaluated in a controlled setting.
Patients (n = 706) completing one of two 14-week double-blind studies of aripiprazole augmentation, as well as de novo patients (n = 296) nonresponsive to current antidepressant therapy, were enrolled in this open-label study. Patients received open-label aripiprazole for up to 52 weeks.
Open-label treatment was completed by 323 patients (32.2%). At endpoint (n = 987), the mean dose of aripiprazole was 10.1 mg/day. Common (>15% of patients) spontaneously reported adverse events were akathisia (26.2%), fatigue (18.0%), and weight gain (17.1%). The incidence of serious adverse events was 4.0%. Four spontaneous reports of possible tardive dyskinesia were submitted (0.4%); all resolved within 45 days of drug discontinuation. Mean weight change was 4.4 kg; 36.6% experienced ≥7% increase in weight from baseline (observed case analysis, n = 303). No clinically relevant changes in other metabolic parameters were seen. At the end of open-label treatment, 221 patients (69.7%) had a Clinical Global Impression-Severity of Illness score of 1 (not at all ill) or 2 (borderline ill).
Long-term adjunctive aripiprazole therapy was well tolerated with an acceptable long-term safety and tolerability profile in patients with major depressive disorder who had not responded to treatment with one or more antidepressant therapies. Clinically significant weight gain was observed in about one-third of patients. Overall, the adverse event profile was consistent with that reported in the short-term trials and readily managed clinically.</description><identifier>ISSN: 1176-6328</identifier><identifier>EISSN: 1178-2021</identifier><identifier>EISSN: 1176-6328</identifier><identifier>DOI: 10.2147/NDT.S18333</identifier><identifier>PMID: 21655344</identifier><language>eng</language><publisher>New Zealand: Taylor & Francis Ltd</publisher><subject>adjunctive aripiprazole ; antidepressant therapy ; Antidepressants ; Clinical significance ; long-term safety and tolerability ; major depressive disorder ; Mental depression ; Original Research</subject><ispartof>Neuropsychiatric disease and treatment, 2011-01, Vol.7 (1), p.303-312</ispartof><rights>2011. This work is licensed under https://creativecommons.org/licenses/by-nc/3.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2011 Berman et al, publisher and licensee Dove Medical Press Ltd. 2011</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c511t-658bb71d4f270ef78bece40277cf33edea47f7ec858a33e0c10239ea6ce0807c3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.proquest.com/docview/2222754193/fulltextPDF?pq-origsite=primo$$EPDF$$P50$$Gproquest$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/2222754193?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,25753,27924,27925,37012,37013,44590,53791,53793,75126</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21655344$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Berman, Robert M</creatorcontrib><creatorcontrib>Thase, Michael E</creatorcontrib><creatorcontrib>Trivedi, Madhukar H</creatorcontrib><creatorcontrib>Hazel, James A</creatorcontrib><creatorcontrib>Marler, Sabrina Vogel</creatorcontrib><creatorcontrib>McQuade, Robert D</creatorcontrib><creatorcontrib>Carson, William</creatorcontrib><creatorcontrib>Baker, Ross A</creatorcontrib><creatorcontrib>Marcus, Ronald N</creatorcontrib><title>Long-term safety and tolerability of open-label aripiprazole augmentation of antidepressant therapy in major depressive disorder</title><title>Neuropsychiatric disease and treatment</title><addtitle>Neuropsychiatr Dis Treat</addtitle><description>Effective management of major depressive disorder often includes the long-term use of multiple medications, and the longer-term utility and safety of adjunctive aripiprazole has not been evaluated in a controlled setting.
Patients (n = 706) completing one of two 14-week double-blind studies of aripiprazole augmentation, as well as de novo patients (n = 296) nonresponsive to current antidepressant therapy, were enrolled in this open-label study. Patients received open-label aripiprazole for up to 52 weeks.
Open-label treatment was completed by 323 patients (32.2%). At endpoint (n = 987), the mean dose of aripiprazole was 10.1 mg/day. Common (>15% of patients) spontaneously reported adverse events were akathisia (26.2%), fatigue (18.0%), and weight gain (17.1%). The incidence of serious adverse events was 4.0%. Four spontaneous reports of possible tardive dyskinesia were submitted (0.4%); all resolved within 45 days of drug discontinuation. Mean weight change was 4.4 kg; 36.6% experienced ≥7% increase in weight from baseline (observed case analysis, n = 303). No clinically relevant changes in other metabolic parameters were seen. At the end of open-label treatment, 221 patients (69.7%) had a Clinical Global Impression-Severity of Illness score of 1 (not at all ill) or 2 (borderline ill).
Long-term adjunctive aripiprazole therapy was well tolerated with an acceptable long-term safety and tolerability profile in patients with major depressive disorder who had not responded to treatment with one or more antidepressant therapies. Clinically significant weight gain was observed in about one-third of patients. Overall, the adverse event profile was consistent with that reported in the short-term trials and readily managed clinically.</description><subject>adjunctive aripiprazole</subject><subject>antidepressant therapy</subject><subject>Antidepressants</subject><subject>Clinical significance</subject><subject>long-term safety and tolerability</subject><subject>major depressive disorder</subject><subject>Mental depression</subject><subject>Original Research</subject><issn>1176-6328</issn><issn>1178-2021</issn><issn>1176-6328</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>PIMPY</sourceid><sourceid>DOA</sourceid><recordid>eNpdUk1v1DAQjRCIloULPwBZ4oCElNaOndi5IKHyVWkFB8rZmjiTrVdJHGxnpeXET8fd7Fa0vnj85unN-Oll2WtGLwom5OX3TzcXP5ninD_JzhmTKi9owZ4e6iqveKHOshchbCnlslbqeXZWsKosuRDn2d-1Gzd5RD-QAB3GPYGxJdH16KGxvU2A64ibcMx7aLAn4O1kJw9_EoXAvBlwjBCtG-94MEbb4uQxhFSSeJtUpj2xIxlg6zw59uwOSWuD8y36l9mzDvqAr473Kvv15fPN1bd8_ePr9dXHdW5KxmJelappJGtFV0iKnVQNGhS0kNJ0nGOLIGQn0ahSQXpTw2jBa4TKIFVUGr7Krhfd1sFWT94O4PfagdUHwPmNBh-t6VG3JQdFG9k1rRDIZVNzIRNiRI2FTEavsg-L1jQ3A7YmWeChfyD6sDPaW71xO80ZFZWqk8DlaZndYsmjjU6ocYOW5WHku-NI737PGKIebDDY9zCim4NWknFFS8oS8-0j5tbNfkze6iIdWQpW88R6v7CMdyF47O4XYFTfpUqnVOklVYn85v__3lNPMeL_ADXOzI4</recordid><startdate>20110101</startdate><enddate>20110101</enddate><creator>Berman, Robert M</creator><creator>Thase, Michael E</creator><creator>Trivedi, Madhukar H</creator><creator>Hazel, James A</creator><creator>Marler, Sabrina Vogel</creator><creator>McQuade, Robert D</creator><creator>Carson, William</creator><creator>Baker, Ross A</creator><creator>Marcus, Ronald N</creator><general>Taylor & Francis Ltd</general><general>Dove Press</general><general>Dove Medical Press</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88G</scope><scope>8AO</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB0</scope><scope>LK8</scope><scope>M0S</scope><scope>M2M</scope><scope>M2O</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope></search><sort><creationdate>20110101</creationdate><title>Long-term safety and tolerability of open-label aripiprazole augmentation of antidepressant therapy in major depressive disorder</title><author>Berman, Robert M ; Thase, Michael E ; Trivedi, Madhukar H ; Hazel, James A ; Marler, Sabrina Vogel ; McQuade, Robert D ; Carson, William ; Baker, Ross A ; Marcus, Ronald N</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c511t-658bb71d4f270ef78bece40277cf33edea47f7ec858a33e0c10239ea6ce0807c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>adjunctive aripiprazole</topic><topic>antidepressant therapy</topic><topic>Antidepressants</topic><topic>Clinical significance</topic><topic>long-term safety and tolerability</topic><topic>major depressive disorder</topic><topic>Mental depression</topic><topic>Original Research</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Berman, Robert M</creatorcontrib><creatorcontrib>Thase, Michael E</creatorcontrib><creatorcontrib>Trivedi, Madhukar H</creatorcontrib><creatorcontrib>Hazel, James A</creatorcontrib><creatorcontrib>Marler, Sabrina Vogel</creatorcontrib><creatorcontrib>McQuade, Robert D</creatorcontrib><creatorcontrib>Carson, William</creatorcontrib><creatorcontrib>Baker, Ross A</creatorcontrib><creatorcontrib>Marcus, Ronald N</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health Medical collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Psychology Database (Alumni)</collection><collection>ProQuest Pharma Collection</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>AUTh Library subscriptions: ProQuest Central</collection><collection>ProQuest Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep (ProQuest)</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ProQuest Biological Science Collection</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>ProQuest Psychology Journals</collection><collection>ProQuest research library</collection><collection>ProQuest Biological Science Journals</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>Publicly Available Content Database (Proquest) (PQ_SDU_P3)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>Neuropsychiatric disease and treatment</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Berman, Robert M</au><au>Thase, Michael E</au><au>Trivedi, Madhukar H</au><au>Hazel, James A</au><au>Marler, Sabrina Vogel</au><au>McQuade, Robert D</au><au>Carson, William</au><au>Baker, Ross A</au><au>Marcus, Ronald N</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Long-term safety and tolerability of open-label aripiprazole augmentation of antidepressant therapy in major depressive disorder</atitle><jtitle>Neuropsychiatric disease and treatment</jtitle><addtitle>Neuropsychiatr Dis Treat</addtitle><date>2011-01-01</date><risdate>2011</risdate><volume>7</volume><issue>1</issue><spage>303</spage><epage>312</epage><pages>303-312</pages><issn>1176-6328</issn><eissn>1178-2021</eissn><eissn>1176-6328</eissn><abstract>Effective management of major depressive disorder often includes the long-term use of multiple medications, and the longer-term utility and safety of adjunctive aripiprazole has not been evaluated in a controlled setting.
Patients (n = 706) completing one of two 14-week double-blind studies of aripiprazole augmentation, as well as de novo patients (n = 296) nonresponsive to current antidepressant therapy, were enrolled in this open-label study. Patients received open-label aripiprazole for up to 52 weeks.
Open-label treatment was completed by 323 patients (32.2%). At endpoint (n = 987), the mean dose of aripiprazole was 10.1 mg/day. Common (>15% of patients) spontaneously reported adverse events were akathisia (26.2%), fatigue (18.0%), and weight gain (17.1%). The incidence of serious adverse events was 4.0%. Four spontaneous reports of possible tardive dyskinesia were submitted (0.4%); all resolved within 45 days of drug discontinuation. Mean weight change was 4.4 kg; 36.6% experienced ≥7% increase in weight from baseline (observed case analysis, n = 303). No clinically relevant changes in other metabolic parameters were seen. At the end of open-label treatment, 221 patients (69.7%) had a Clinical Global Impression-Severity of Illness score of 1 (not at all ill) or 2 (borderline ill).
Long-term adjunctive aripiprazole therapy was well tolerated with an acceptable long-term safety and tolerability profile in patients with major depressive disorder who had not responded to treatment with one or more antidepressant therapies. Clinically significant weight gain was observed in about one-third of patients. Overall, the adverse event profile was consistent with that reported in the short-term trials and readily managed clinically.</abstract><cop>New Zealand</cop><pub>Taylor & Francis Ltd</pub><pmid>21655344</pmid><doi>10.2147/NDT.S18333</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
fulltext | fulltext |
identifier | ISSN: 1176-6328 |
ispartof | Neuropsychiatric disease and treatment, 2011-01, Vol.7 (1), p.303-312 |
issn | 1176-6328 1178-2021 1176-6328 |
language | eng |
recordid | cdi_doaj_primary_oai_doaj_org_article_d53a80b7fbd44e37b9347a80c49e2718 |
source | Publicly Available Content Database (Proquest) (PQ_SDU_P3); Taylor & Francis Open Access; PubMed Central Free |
subjects | adjunctive aripiprazole antidepressant therapy Antidepressants Clinical significance long-term safety and tolerability major depressive disorder Mental depression Original Research |
title | Long-term safety and tolerability of open-label aripiprazole augmentation of antidepressant therapy in major depressive disorder |
url | http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-02T12%3A57%3A08IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_doaj_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Long-term%20safety%20and%20tolerability%20of%20open-label%20aripiprazole%20augmentation%20of%20antidepressant%20therapy%20in%20major%20depressive%20disorder&rft.jtitle=Neuropsychiatric%20disease%20and%20treatment&rft.au=Berman,%20Robert%20M&rft.date=2011-01-01&rft.volume=7&rft.issue=1&rft.spage=303&rft.epage=312&rft.pages=303-312&rft.issn=1176-6328&rft.eissn=1178-2021&rft_id=info:doi/10.2147/NDT.S18333&rft_dat=%3Cproquest_doaj_%3E2222754193%3C/proquest_doaj_%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c511t-658bb71d4f270ef78bece40277cf33edea47f7ec858a33e0c10239ea6ce0807c3%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=2222754193&rft_id=info:pmid/21655344&rfr_iscdi=true |