Table 2.

Published efficacy trials of duloxetine in other mood disorders.

Authors/year of publication	Study design	Trial duration	Number of patients	Duloxetine regimen	Active comparator regimen	Primary outcome measure	Main efficacy results
Persistent depressive disorder
Koran et al., 2007 (29)	Open-label, uncontrolled	12 weeks	24	60–120 mg/day	NA	IDS-C	IDS-C (ITT): response rate = 83%; remission rate = 79%
Kerner et al., 2014 (30)	Open-label, uncontrolled	12 weeks	30	20–120 mg/day	NA	HDRS	HDRS (ITT): response rate = 53.3%; remission rate (ITT) = 33.3%; daily doses above 60 mg were associated with greater improvement and well tolerated
Hellerstein et al., 2012 (31)	Randomized, double-blind, placebo-controlled	10 weeks	65	30–120 mg/day	NA/Pl	HDRS	HDRS: response rate DUL vs. Pl = 65.5% vs. 25.0% (p = 0.003); remission rate DUL vs. Pl = 55.2% vs. 14.3% (p = 0.002)
Hellerstein et al., 2017 (32)	Open-label, observational	12 weeks	19 D24 Pl → D	30–120 mg/day	NA	HDRS	Patients continuing DUL: response criteria = 84%, remission criteria = 63%.Patients initially Pl: response criteria = 83%, remission criteria = 62%
Seasonal affective disorder
Pjirek et al., 2008 (33)	Open-label, uncontrolled	8 weeks	26	60–120 mg/day	NA	SIGH-SAD	SIGH-SAD (ITT): response rate = 80.8%; remission rate = 76.9%
Premenstrual dysphoric disorder
Mazza et al., 2008 (34)	Open-label, uncontrolled	Two menstrual cycles	55	60 mg/day	NA	VAS-Mood	VAS-Mood: response rate = 78%
Ramos et al., 2009 (35)	Single-blind, uncontrolled	Three menstrual cycles	20	60 mg/day	NA/Pl	DRSP	DRSP (ITT): response rate = 65%

DUL, duloxetine; NA, not available; Pl, placebo; IDS-C, Inventory for Depressive Symptomatology; HDRS, Hamilton Depression Rating Scale; SIGH-SAD, Structured Interview Guide for the Hamilton Rating Scale–SAD version; VAS-Mood, visual analog scale–mood; DRSP, Daily Record of Severity of Problems; ITT, intent-to-treat.