{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T01:28:09Z","timestamp":1777858089332,"version":"3.51.4"},"reference-count":37,"publisher":"SAGE Publications","issue":"9","license":[{"start":{"date-parts":[[2017,8,31]],"date-time":"2017-08-31T00:00:00Z","timestamp":1504137600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Psychopharmacol"],"published-print":{"date-parts":[[2017,9]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>This randomized, double-blind, placebo-controlled study evaluated dose-response relationships of lisdexamfetamine dimesylate when used as augmentation for major depressive disorder in individuals exhibiting inadequate responses to antidepressant monotherapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Eligible adults (18\u201365 years) were assigned to antidepressant monotherapy (escitalopram or venlafaxine extended-release) plus lisdexamfetamine dimesylate-matching placebo during an eight-week single-blind lead-in phase. Participants meeting randomization criteria were randomized (1:1:1:1:1) to eight weeks of lisdexamfetamine dimesylate (10, 30, 50, or 70 mg) or placebo while maintaining antidepressant therapy. Dose-responses for changes from augmentation baseline to week 16\/early termination for Montgomery-\u00c5sberg Depression Rating Scale total score (primary efficacy endpoint) and vital signs (systolic and diastolic blood pressure and pulse) were assessed using multiple comparisons procedures with modeling.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>For Montgomery-\u00c5sberg Depression Rating Scale total score change, no significant dose-responses were observed for any candidate dose-response curve (all p&gt;0.10). In the dose-response evaluable population, least squares mean (90% confidence interval) treatment differences versus placebo for Montgomery-\u00c5sberg Depression Rating Scale total score change at week 16 were \u22121.4 (\u22123.9, 1.2), 0.1 (\u22122.5, 2.7), \u22120.7 (\u22123.4, 2.0), and \u22120.9 (\u22123.5, 1.6) with 10, 30, 50, and 70 mg lisdexamfetamine dimesylate, respectively. For all vital sign parameters, lisdexamfetamine dimesylate exhibited significant dose-responses for all candidate dose-response curves (all p&lt;0.10), with increases observed as lisdexamfetamine dimesylate dose increased; a linear relationship provided the best fit. Mean\u00b1standard deviation changes from augmentation baseline for systolic and diastolic blood pressure and pulse at week 16\/early termination were \u22120.7\u00b19.90 and \u22120.3\u00b17.24 mm Hg and 0.2\u00b110.57 bpm with placebo and were 1.9\u00b19.47 and 0.8\u00b17.40 mm Hg and 3.6\u00b19.74 bpm with lisdexamfetamine dimesylate (all doses combined). The safety and tolerability profile of lisdexamfetamine dimesylate was consistent with previous studies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Lisdexamfetamine dimesylate augmentation did not provide benefit over placebo in adults with inadequate responses to antidepressant monotherapy based on the assessed efficacy measures.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/0269881117722998","type":"journal-article","created":{"date-parts":[[2017,8,31]],"date-time":"2017-08-31T10:29:41Z","timestamp":1504175381000},"page":"1190-1203","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":15,"title":["A randomized, double-blind, placebo-controlled, dose-ranging study of lisdexamfetamine dimesylate augmentation for major depressive disorder in adults with inadequate response to antidepressant therapy"],"prefix":"10.1177","volume":"31","author":[{"given":"Cynthia","family":"Richards","sequence":"first","affiliation":[{"name":"Formerly of Shire, Lexington, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dan V","family":"Iosifescu","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, New York University School of Medicine, New York, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rajnish","family":"Mago","sequence":"additional","affiliation":[{"name":"Private Practice, Philadelphia, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elias","family":"Sarkis","sequence":"additional","affiliation":[{"name":"Sarkis Family Psychiatry, Gainesville, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James","family":"Reynolds","sequence":"additional","affiliation":[{"name":"Formerly of Shire, Lexington, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brooke","family":"Geibel","sequence":"additional","affiliation":[{"name":"Formerly of Shire, Lexington, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew","family":"Dauphin","sequence":"additional","affiliation":[{"name":"Formerly of Shire, Lexington, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2017,8,31]]},"reference":[{"key":"bibr1-0269881117722998","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.v69n0903"},{"key":"bibr2-0269881117722998","doi-asserted-by":"publisher","DOI":"10.1370\/afm.349"},{"key":"bibr3-0269881117722998","doi-asserted-by":"publisher","DOI":"10.1111\/j.1541-0420.2005.00344.x"},{"key":"bibr4-0269881117722998","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD006722.pub2"},{"key":"bibr5-0269881117722998","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(09)60046-5"},{"key":"bibr6-0269881117722998","doi-asserted-by":"publisher","DOI":"10.1001\/archpsyc.64.3.327"},{"key":"bibr7-0269881117722998","doi-asserted-by":"publisher","DOI":"10.1517\/17425255.2012.671295"},{"key":"bibr8-0269881117722998","unstructured":"European Medicines Agency Committee for Medicinal Products for Human Use (2014) Qualification opinion of MCP-Mod as an efficient statistical methodology for model-based design and analysis of phase II dose finding studies under model uncertainty. 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