PMC:546184 / 8251-9755 JSONTXT

{"target":"https://pubannotation.org/docs/sourcedb/PMC/sourceid/546184","sourcedb":"PMC","sourceid":"546184","source_url":"http://www.ncbi.nlm.nih.gov/pmc/546184","text":"Study Design\nAll 8 studies included in these analyses were randomized, multicenter, double-blind, placebo-controlled clinical trials and represented all of the double-blind studies included in the New Drug Application reviewed by regulatory agencies for duloxetine's indication in MDD. All studies incorporated double-blind, variable-expected duration placebo lead-in periods to blind patients and investigators to the start of active therapy. Six studies also utilized an active comparator – fluoxetine (20 mg QD) in Studies 1 and 2, and paroxetine (20 mg QD) in Studies 3, 4, 7, and 8. Study protocols were reviewed and approved by the ethical review board at each center, in accordance with the principles of the Declaration of Helsinki, and all patients provided written informed consent prior to the administration of any study procedures or study drug. The numbers of patients randomized in each study are summarized in Table 1. Detailed safety and efficacy results from Studies 1 [39], 4 [40], 5 [41], and 6 [42] have been published previously.\nTable 1 Numbers of randomized patients‡ ‡ Data presented in the form T (% M), where T = total number of patients, % M = percentage of patients with melancholic features\na. SSRI in Studies 1 and 2 is fluoxetine (20 mg QD). SSRI in Studies 3, 4, 7, and 8 is paroxetine (20 mg QD).\nb. Administered 20 mg twice-daily (BID)\nc. Administered 40 mg BID\nd. Administered 60 mg BID. Studies 1 and 2 incorporated a forced titration from 20 mg BID to 60 mg BID.\n\n","divisions":[{"label":"Title","span":{"begin":0,"end":12}},{"label":"Table caption","span":{"begin":1052,"end":1503}}],"tracks":[{"project":"2_test","denotations":[{"id":"15631624-11926722-13857383","span":{"begin":988,"end":990},"obj":"11926722"},{"id":"15631624-15232330-13857384","span":{"begin":996,"end":998},"obj":"15232330"},{"id":"15631624-12000204-13857385","span":{"begin":1004,"end":1006},"obj":"12000204"},{"id":"15631624-12393307-13857386","span":{"begin":1016,"end":1018},"obj":"12393307"}],"attributes":[{"subj":"15631624-11926722-13857383","pred":"source","obj":"2_test"},{"subj":"15631624-15232330-13857384","pred":"source","obj":"2_test"},{"subj":"15631624-12000204-13857385","pred":"source","obj":"2_test"},{"subj":"15631624-12393307-13857386","pred":"source","obj":"2_test"}]},{"project":"NEUROSES","denotations":[{"id":"T162","span":{"begin":91,"end":96},"obj":"PATO_0001177"},{"id":"T163","span":{"begin":167,"end":172},"obj":"PATO_0001177"},{"id":"T164","span":{"begin":318,"end":323},"obj":"PATO_0001177"},{"id":"T165","span":{"begin":379,"end":384},"obj":"PATO_0001177"},{"id":"T166","span":{"begin":201,"end":205},"obj":"CHEBI_23888"},{"id":"T167","span":{"begin":853,"end":857},"obj":"CHEBI_23888"},{"id":"T168","span":{"begin":206,"end":217},"obj":"CHEBI_33232"},{"id":"T169","span":{"begin":254,"end":264},"obj":"CHEBI_36796"},{"id":"T170","span":{"begin":281,"end":284},"obj":"CHEBI_566274"},{"id":"T171","span":{"begin":325,"end":333},"obj":"PATO_0001227"},{"id":"T172","span":{"begin":343,"end":351},"obj":"PATO_0001309"},{"id":"T173","span":{"begin":360,"end":364},"obj":"CHEBI_25016"},{"id":"T174","span":{"begin":360,"end":364},"obj":"CHEBI_27889"},{"id":"T175","span":{"begin":428,"end":434},"obj":"PATO_0002354"},{"id":"T176","span":{"begin":473,"end":479},"obj":"PATO_0002354"},{"id":"T177","span":{"begin":493,"end":503},"obj":"CHEBI_5118"},{"id":"T178","span":{"begin":539,"end":549},"obj":"CHEBI_7936"}],"attributes":[{"subj":"T162","pred":"source","obj":"NEUROSES"},{"subj":"T163","pred":"source","obj":"NEUROSES"},{"subj":"T164","pred":"source","obj":"NEUROSES"},{"subj":"T165","pred":"source","obj":"NEUROSES"},{"subj":"T166","pred":"source","obj":"NEUROSES"},{"subj":"T167","pred":"source","obj":"NEUROSES"},{"subj":"T168","pred":"source","obj":"NEUROSES"},{"subj":"T169","pred":"source","obj":"NEUROSES"},{"subj":"T170","pred":"source","obj":"NEUROSES"},{"subj":"T171","pred":"source","obj":"NEUROSES"},{"subj":"T172","pred":"source","obj":"NEUROSES"},{"subj":"T173","pred":"source","obj":"NEUROSES"},{"subj":"T174","pred":"source","obj":"NEUROSES"},{"subj":"T175","pred":"source","obj":"NEUROSES"},{"subj":"T176","pred":"source","obj":"NEUROSES"},{"subj":"T177","pred":"source","obj":"NEUROSES"},{"subj":"T178","pred":"source","obj":"NEUROSES"}]}],"config":{"attribute types":[{"pred":"source","value type":"selection","values":[{"id":"2_test","color":"#9bec93","default":true},{"id":"NEUROSES","color":"#ec93b5"}]}]}}