PubMed:23473348 JSONTXT

{"target":"https://pubannotation.org/docs/sourcedb/PubMed/sourceid/23473348","sourcedb":"PubMed","sourceid":"23473348","source_url":"http://www.ncbi.nlm.nih.gov/pubmed/23473348","text":"Efficacy and safety of desvenlafaxine 50 mg/d for prevention of relapse in major depressive disorder:a randomized controlled trial.\nOBJECTIVE: To evaluate the long-term (11-month) efficacy and safety of desvenlafaxine (administered as desvenlafaxine succinate) at the recommended 50-mg/d dose in preventing relapse in patients with major depressive disorder (MDD).\nMETHOD: Adult outpatients (age ≥ 18 years) with MDD (DSM-IV criteria) and a 17-item Hamilton Depression Rating Scale (HDRS17) total score ≥ 20 at screening and baseline were enrolled in a multicenter, double-blind, placebo-controlled, randomized withdrawal trial conducted between June 2009 and March 2011. Patients who responded to 8-week open-label treatment with desvenlafaxine 50 mg/d with continuing stable response through week 20 were randomly assigned to receive placebo or desvenlafaxine 50 mg/d in a 6-month, double-blind, randomized withdrawal period. The primary efficacy endpoint was time to relapse following randomization to double-blind treatment, which was compared between groups using the log-rank test. Relapse was defined as HDRS17 total score ≥ 16, discontinuation for unsatisfactory response, hospitalization for depression, suicide attempt, or suicide. Safety and tolerability data were collected throughout the trial.\nRESULTS: A total of 874 patients were enrolled; 548 patients were randomly assigned to receive placebo (n = 276) or desvenlafaxine 50 mg/d (n = 272) in the double-blind withdrawal period. Time to relapse was significantly shorter for placebo versus desvenlafaxine (P \u003c .001). At the end of the 6-month double-blind treatment, the estimated probability of relapse was 30.2% for placebo versus 14.3% for desvenlafaxine 50 mg/d. Safety and tolerability results were generally consistent with those in short-term studies of desvenlafaxine 50 mg/d.\nCONCLUSIONS: Desvenlafaxine at the recommended dose of 50 mg/d was effective in relapse prevention of depression during a 6-month period in patients who demonstrated stable response after 20 weeks of open-label desvenlafaxine treatment.\nTRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00887224.","tracks":[{"project":"Allie","denotations":[{"id":"SS1_23473348_2_0","span":{"begin":332,"end":357},"obj":"expanded"},{"id":"SS2_23473348_2_0","span":{"begin":359,"end":362},"obj":"abbr"}],"relations":[{"id":"AE1_23473348_2_0","pred":"abbreviatedTo","subj":"SS1_23473348_2_0","obj":"SS2_23473348_2_0"}],"attributes":[{"subj":"SS1_23473348_2_0","pred":"source","obj":"Allie"},{"subj":"SS2_23473348_2_0","pred":"source","obj":"Allie"}]},{"project":"PubmedHPO","denotations":[{"id":"T1","span":{"begin":338,"end":348},"obj":"HP_0000716"}],"attributes":[{"subj":"T1","pred":"source","obj":"PubmedHPO"}]},{"project":"maxiaofeng52_800_3","denotations":[{"id":"T1","span":{"begin":23,"end":37},"obj":"CI"},{"id":"T10","span":{"begin":2063,"end":2077},"obj":"CI"},{"id":"T11","span":{"begin":1403,"end":1410},"obj":"CI"},{"id":"T12","span":{"begin":580,"end":587},"obj":"CI"},{"id":"T13","span":{"begin":836,"end":843},"obj":"CI"},{"id":"T14","span":{"begin":1542,"end":1549},"obj":"CI"},{"id":"T15","span":{"begin":1685,"end":1692},"obj":"CI"},{"id":"T16","span":{"begin":1865,"end":1879},"obj":"CI"},{"id":"T17","span":{"begin":75,"end":100},"obj":"DP"},{"id":"T18","span":{"begin":332,"end":357},"obj":"DP"},{"id":"T19","span":{"begin":359,"end":362},"obj":"DP"},{"id":"T2","span":{"begin":203,"end":217},"obj":"CI"},{"id":"T20","span":{"begin":413,"end":416},"obj":"DP"},{"id":"T3","span":{"begin":235,"end":249},"obj":"CI"},{"id":"T4","span":{"begin":731,"end":745},"obj":"CI"},{"id":"T5","span":{"begin":847,"end":861},"obj":"CI"},{"id":"T6","span":{"begin":1424,"end":1438},"obj":"CI"},{"id":"T7","span":{"begin":1557,"end":1571},"obj":"CI"},{"id":"T8","span":{"begin":1710,"end":1724},"obj":"CI"},{"id":"T9","span":{"begin":1828,"end":1842},"obj":"CI"},{"id":"T21","span":{"begin":1201,"end":1211},"obj":"DP"},{"id":"T22","span":{"begin":1954,"end":1964},"obj":"DP"}],"attributes":[{"subj":"T1","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T10","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T11","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T12","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T13","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T14","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T15","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T16","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T17","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T18","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T19","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T2","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T20","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T3","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T4","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T5","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T6","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T7","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T8","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T9","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T21","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T22","pred":"source","obj":"maxiaofeng52_800_3"}]},{"project":"wangzhuo19_800_3","denotations":[{"id":"T2","span":{"begin":332,"end":357},"obj":"DP"},{"id":"T3","span":{"begin":359,"end":362},"obj":"DP"},{"id":"T4","span":{"begin":75,"end":100},"obj":"DP"},{"id":"T5","span":{"begin":413,"end":416},"obj":"DP"},{"id":"T6","span":{"begin":1954,"end":1964},"obj":"DP"},{"id":"T7","span":{"begin":1201,"end":1211},"obj":"DP"},{"id":"T8","span":{"begin":23,"end":37},"obj":"CI"},{"id":"T9","span":{"begin":203,"end":217},"obj":"CI"},{"id":"T10","span":{"begin":235,"end":249},"obj":"CI"},{"id":"T11","span":{"begin":731,"end":745},"obj":"CI"},{"id":"T12","span":{"begin":847,"end":861},"obj":"CI"},{"id":"T13","span":{"begin":1424,"end":1438},"obj":"CI"},{"id":"T14","span":{"begin":1557,"end":1571},"obj":"CI"},{"id":"T15","span":{"begin":1710,"end":1724},"obj":"CI"},{"id":"T16","span":{"begin":1828,"end":1842},"obj":"CI"},{"id":"T17","span":{"begin":2063,"end":2077},"obj":"CI"},{"id":"T18","span":{"begin":1865,"end":1879},"obj":"CI"},{"id":"T19","span":{"begin":580,"end":587},"obj":"CI"},{"id":"T20","span":{"begin":836,"end":843},"obj":"CI"},{"id":"T21","span":{"begin":1403,"end":1410},"obj":"CI"},{"id":"T22","span":{"begin":1542,"end":1549},"obj":"CI"},{"id":"T23","span":{"begin":1685,"end":1692},"obj":"CI"}],"attributes":[{"subj":"T2","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T3","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T4","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T5","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T6","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T7","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T8","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T9","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T10","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T11","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T12","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T13","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T14","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T15","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T16","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T17","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T18","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T19","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T20","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T21","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T22","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T23","pred":"source","obj":"wangzhuo19_800_3"}]}],"config":{"attribute types":[{"pred":"source","value type":"selection","values":[{"id":"Allie","color":"#93ec95","default":true},{"id":"PubmedHPO","color":"#ec93aa"},{"id":"maxiaofeng52_800_3","color":"#93c4ec"},{"id":"wangzhuo19_800_3","color":"#deec93"}]}]}}